Applied Nursing Research 28 (2015) 374–380
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Applied Nursing Research journal homepage: www.elsevier.com/locate/apnr
Original Article
Improving sleep quality interventions among menopausal women with sleep disturbances in Taiwan: a preliminary study Hsiu-Chin Hsu, PhD, RN a, Lee-Ing Tsao, DNSc b, Mei-Hsiang Lin, EdD, RN b,⁎ a b
Department of Nursing Chang Gung University of Science and Technology, Taiwan, ROC National Taipei University of Nursing and Health Science, Taipei, Taiwan
a r t i c l e
i n f o
Article history: Received 1 September 2014 Revised 17 January 2015 Accepted 24 January 2015 Available online xxxx Keywords: Sleep quality Menopause Improving sleep quality intervention Actiwatch
a b s t r a c t Aim: The aim of this study was to evaluate the effectiveness of improving sleep quality interventions in menopausal women with sleep disturbance. Background: Sleep disturbances are an extensive and common problem among menopausal women. There is an increased trend in the use of non-pharmacological methods to alleviate sleep disturbances. Studies that have implemented two or more non-pharmacological strategies for menopausal women are scant. Methods: A repeat measurement with a randomized assignment was conducted. A total of 59 menopausal women with sleep disturbance were recruited and randomly assigned to experimental (n = 29) and control (n = 30) groups. Participants in the experimental group received four 2-hour improving sleep quality activities, whereas the control group received regular greeting calls. Sleep quality was measured prior to intervention, and on the 5th and 8th weeks by using the Pittsburg’s Sleep Quality Index, and Actiwatch was worn before and during the 8 weeks of intervention. Generalized estimating equation was used to analyze data. Results: The results revealed that subjective sleep quality had significant main effect in group and time. The findings of the objective measurement showed that participants in the experimental group had significantly shorter frequency of awakening time and increased sleep efficiency. Conclusion: The improving sleep quality intervention is a healthy and cost-effective method to improve sleep quality in community-dwelling menopausal women with sleep disturbance. © 2015 Elsevier Inc. All rights reserved.
1. Introduction Menopausal women face a crucial transitional time in life. During this period, women undergo substantial biological, psychological, and social changes. This includes gradual physiological degeneration, with a considerable decrease in the production of sleep quality-regulating hormones such as estrogen and progesterone. In addition, because women have different social and cultural expectations than men (Senba & Matsuo, 2010), the multi-faceted phenomenon produces changes in the sleep-controlling neuroendocrine system, causing sleep disorders (Manocha, Semmar, & Black, 2007). Studies done on the prevalence of menopausal symptoms have reported that approximately 20 to 60% of menopausal women complain about having sleep disorders (Eichling & Sahni, 2005; Moilanen et al., 2010; Woods & Mitchell,
Funding: This study was supported by the grant from Chang Gung Medical Foundation, Taiwan, ROC (no. CMRPF1A0081). Conflict of interest: No conflict of interest had been declared by the authors. Authors' contribution: HH-C was responsible for the study conception and design. HHC was responsible drafting of the manuscript. HH-C, LM-H and Tsao L-I made critical revisions to the paper for important intellectual content. ⁎ Corresponding author at: No.365, Ming-te Road, Peitou District, Taipei City, Taiwan, ROC. Tel.: + 886 2 28227101. E-mail addresses: [email protected] (H.-C. Hsu), [email protected] (L.-I. Tsao), [email protected] (M.-H. Lin). http://dx.doi.org/10.1016/j.apnr.2015.01.004 0897-1897/© 2015 Elsevier Inc. All rights reserved.
2005), indicating the prevalence and severity of sleep-related problems. It is extremely crucial to care for the health of menopausal women because menopausal women with long-term sleep disturbances will ultimately exhibit comparatively poorer physiological and mental health and a deteriorating quality of life. These problems initiate a vicious cycle that will negatively impact the quality of their life in later years. In recent years, studies on improving the sleep quality of menopausal women have garnered increased attention. Ong, Shapiro, and Manber (2008) indicated an increased trend in the use of non-pharmacological methods to alleviate sleep disturbances. It is generally believed that the combined use of multiple behavioral techniques to improve sleep quality is more effective than a single technique. However, current solutions introduced in most studies employ only a single intervention to improve the sleep disturbance experienced by menopausal women (Elavsky & McAuley, 2007; Senba & Matsuo, 2010). Studies that have implemented two or more intervention strategies are scant. When considering the intervention strategies used to improve the sleep quality of menopausal women, these strategies must also reduce the pressure that menopausal women experience because of both physiological and mental changes, while easing the sleep problems caused by neuroendocrine changes. Therefore, a set of strategies to improve sleep quality primarily focused on reducing pressure by engaging in self-relaxation exercises was used in this study. The strategies included stressrelieving low-intensity exercises, meditation with diaphragmatic
H-C. Hsu et al. / Applied Nursing Research 28 (2015) 374–380
breathing, progressive muscle relaxation, and sleep hygiene education. These approaches were modeled on some previous studies which have found significantly reducing the level of nervous tension (Kaul, Passafiume, Sargent, & O'Hara, 2010). Notably, the social cognitive theory is a useful behavioral theory to improve health care outcomes (Bandura, 1986). Therefore, the intervention was informed by the social cognitive theory to improve the sleep quality of menopausal women. 2. Background Meditation is used to train individuals to focus on a single object, voice, or experience (Cardoso, Souza, Camano, & Leite, 2004). By meditating, the awareness of the body is lowered, the intensity of the circulating hormones created by pressure is changed, and the activities associated with the sympathetic nervous system, such as the beating of the heart, breathing, and hot flashes are reduced. In addition, by correctly and continuously practicing meditation, individuals can enhance the α wave in their brain, which eliminates worry and reduces tension. This achieves mental stability and enhances sleep quality (Kaul et al., 2010, Manocha et al., 2007). A number of sleep-related studies have used meditation as the intervention strategy to help people with sleep disorders. Results showed a significant decrease in total awake time during the night, which improved sleep efficiency and sleep quality (Ong et al., 2008, Ong, Shapiro, & Manber, 2009). The efficacy of stress-relieving exercises to reduce pressure and divert attention away from stressful events has been extensively documented (Ghoncheh & Smith, 2004; Kwekkeboom & Gretarsdottir, 2006). The exercises primarily entail the stretching of selected muscles to a maximum distance before holding still for 10 seconds and then slowly relaxing each muscle. Concurrently, the individuals rhythmically breathe in and out to produce anxiety-diversion and pressurereduction effects. Moreover, diaphragmatic breathing has long been considered the simplest and easiest technique to learn. By engaging in diaphragmatic breathing, the parasympathetic nervous system is excited and physiological and mental stimulations are reduced, immediately achieving the effect of pressure reduction when stressful events are forthcoming (Consolo, Fusner, & Staib, 2008; Kwekkeboom & Gretarsdottir, 2006). Regarding the progressive muscle relaxation technique, it has also been proven by empirical studies to have a multileveled positive effect on people experiencing physical and psychological discomfort (Rausch, Gramling, & Auerbach, 2006). The progressive muscle relaxation technique primarily involves the gradual tightening of the muscles from head to toe for 15 seconds and then the relaxation of the muscles for approximately 30 seconds. This technique can help control anxiety and create a physiological hypo-arousal effect (Rausch et al., 2006). Furthermore, sleep hygiene can help individuals with insomnia identify appropriate ways to correct their lifestyle choices and improve their sleep quality (Lynch, Jarvis, DeBellis, & Morin, 2007). Adachi, Sato, Kunitsuka, Hayama, and Doi (2008) conducted a longitudinal study and follow-up with the participants 1 year after the experiment also showed substantial sleep quality improvement. Thus, Adachi et al. recommended sleep hygiene education to encourage people to change unhealthy behaviors for improving their sleep quality. The purpose of this study was to evaluate the effects of improving sleep quality intervention on sleep disturbance through subjective and objective parameters in menopausal women. It was expected that menopausal women receiving interventions would experience enhanced sleep quality. 3. Methods 3.1. Design This study adopted a repeat measurement with a randomized assignment and a controlled trial. Sixty-three participants were
375
randomly assigned into two groups in a 1:1 ratio by neighborhood to avoid diffusion of treatment effect. The investigator drew from two sealed envelopes determining which participants would be in the experimental group and which in the control group. The experimental group received four 2-hour sleep quality-improvement intervention activities whereas the control group received only regular care or greeting calls. Upon completing these activities, the same sleep intervention teaching materials were given to the control group. The investigator explained the results of the sleep data of each participant that was collected from three questionnaires and two sleep-recording watches. 3.2. Participants Menopausal women with sleep disturbance were recruited from one of the townships in Central Taiwan. The GPower3.05 software was used to estimate the sample size and perform statistical tests on the two groups through ANOVA-repeat measure-between factors. The value of α, power, Cohen's rule effect size, and a medium autocorrelation were set at 0.05, 0.8, 0.3, and 0.5 respectively. An ideal sample size was 62, with each group comprising 31 members. By conducting a women's health lecture, posting flyers, and receiving referrals, 84 volunteers who were community-dwelling menopausal women were recruited. After removing 21 participants who failed to satisfy our inclusion criteria, the final number of participants was 63. Inclusion criteria were: (1) be between 45 and 60 years of age, (2) experience sleep difficulty for at least 3 days a week over the past month, (3) have a total score higher than five on the Pittsburg sleep quality index, (4) have no mental illness or severe illness such as cancer, heart disease, or lung disease, and (5) be willing to participate in an 8-week intervention activity. Exclusion criteria were: (1) have a habit of using sedatives, hypnotic drugs, or hormone medication, and (2) attend or are still attending sleep improvement-related lessons within the past 6 months. During the intervention period, three participants from the experimental group and one from the control group had to drop out of the study. Therefore, the remaining participants in the experimental and control groups successfully completing the study were 29 and 30, respectively (Fig. 1). 3.3. Intervention The theoretical framework for intervention program which primarily focused on reducing stress and promoting self-relaxation was based on the social cognitive theory. In the first lesson, the investigator introduced information concerning menopausal women with sleep disturbance and explained the sleep-improvement intervention program. In the second lesson, the participants were taught eight stress-relieving exercises, followed by meditation and learning how to focus on diaphragmatic breathing. A stress-relieving exercise expert was invited to the lesson for guidance and consultation. Lecture notes containing the program content were provided to each participant, including a reminder to practice at home at least 30 minutes daily. Next, the investigator made an Intervention At-Home Practice Log and required each participant to set goals and self-monitor their practice time, frequency, and any difficulties they experienced as references for assessment as well as solve problems. In the third lesson, the participants were divided into groups containing three to five members. During the lesson, the progressive muscle relaxation video was played to teach the participants how to relax their muscles and instruct them on how to duplicate the movements they heard on the CD. Additionally, the investigator provided the participants with a progressive muscle relaxation CD. The CD taught them how to lie still in bed 30 minutes before going to sleep by following the instructions to slowly relax and guide themselves to sleep. In the fourth lesson, the investigator gave each group a sleep hygiene education booklet. These provided them with information that could improve
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Fig. 1. Trial Profile.
their sleep quality. During these lessons, the participants were motivated to share their experiences and receive answers to their questions. A discussion time was allotted at the end of each of the four lessons to encourage the participants to ask questions pertaining to the lesson or to share their ideas. At the same time, the researcher asked the participants to complete the program and continually provided positive reinforcement of crucial behaviors. The purposes of these sessions were provided opportunities for observational learning, goal-setting, selfmonitoring, and social support from the social cognitive theory to help participants obtaining related behaviors (mediation and exercises). Consequently the pressure was reduced by performing the behaviors and the quality of sleep was improved. 3.4. Data collection Prior to conducting the intervention activities, each individual was required to fill out the questionnaires to build the baseline data. Concurrently, the participants were asked to wear a sleep-recording watch called Actiwatch. To prevent inconsistencies in watch-wearing time because of varying levels of activity during weekdays and weekends, the participants were instructed to wear the watch between Monday and Thursday. Considering the possibility of underestimated sleep quality on the first night, the participants were asked to wear the Actiwatches for two consecutive days (Freedman & Reohrs, 2004). Finally, the investigator reaffirmed to the participants that in weeks 5 and 8a trained research assistant would collect their subjective sleep-related data and ask the participants to wear the Actiwatch again in week 8. 3.5. Instruments validity and reliability The CPSQI contains 19 questions divided into seven major components: sleep latency, subjective sleep quality, sleep duration, sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. A score of zero to three was assigned to each component and each participant could get a global score of zero to
twenty-one. Higher scores indicated poorer sleep quality and participants with a global score higher than five were considered to have poor sleep quality. Regarding the reliability of the CPSQI, it showed an internal consistency and split-half reliability of 0.82–0.83 and 0.94, respectively (Tsai et al., 2005). In this study, the pilot study showed the Cronbach's α was 0.75, and the formal study demonstrated the Cronbach's α was 0.70. The Actiwatch is a wristwatch-sized device that has been widely used in clinical practice and research to investigate sleeping problems. The validity of the Actiwatch has been confirmed by using the polysomnography to distinguish between being asleep and being awake. Concurrently, the reliability of the Actiwatch exhibited a correlation coefficient of 0.88 with polysomnography. In this study, the Actiwatch-64 produced by the Mini Mitter Company was employed (2005) to objectively assess the sleep quality of menopausal women. The indices included sleep latency (the time it took for them to shut off the light and fall asleep), snooze time (the time it took for them to get out of bed after waking up), sleep efficiency (the ratio between the time they were fully asleep and the total time they spent in bed, multiplied by 100), the percent they were awake (the ratio between the total awake time at night and the total sleep time, multiplied by 100), and the total sleep time (the period between the time that they climbed into bed and the time they got out of bed). 3.6. Ethical considerations The original study protocol was approved by the Institutional Review Board of the appropriate university. All the participants received a detailed explanation regarding the study and all signed informed consent forms. 3.7. Data analysis SPSS 15.0 for Windows was used for data analyses. A t test for independent samples, chi-squared test, and Fisher's exact test were
H-C. Hsu et al. / Applied Nursing Research 28 (2015) 374–380
4. Results
Table 1 Baseline characteristics of the study participants. Experimental (n = 29) n Age Menopausal status Pre-menopause Peri-menopause Post-menopause Employment No Yes Hypnotic use No Yes Education Elementary or illiterate Junior or senior high school Above college Marital status Married Divorced Widowed Single Exercise No Yes Chronic disease No Yes
%
29
377
Control (n = 30)
Mean
SD
n
%
49.52
4.03
30
13 10 6
44.8 34.5 20.7
10 9 11
33.3 30.0 36.7
6 23
20.7 79.3
2 28
6.7 93.3
21 8
72.4 27.6
23 7
76.7 23.3
2
6.9
1
3.3
21
72.4
25
83.3
6
20.7
4
13.3
22 3 2 2
75.9 10.3 6.9 6.9
24 3 1 2
80.0 10.0 3.3 6.7
15 14
51.7 48.3
20 10
66.7 33.3
14 15
48.3 51.7
20 10
66.7 33.3
Mean
SD
49.57
3.41
4.1. Characteristics of the participants
t/χ2/ Fisher's exact
A total of 59 women fully participated in this study. The experimental group was composed of 29 members with an average age of 49.52 (SD 4.03); the control group consisted of 30 members with an average age of 49.57 (SD 3.41). The baseline characteristics of the two groups did not exhibit significant differences (Table 1). Moreover, there was no significant difference in the baseline subjective sleep parameter between two groups. (t = −0.59, p = .56).
−.51 .1.89
2.43
4.2. The effects of the intervention on sleep quality
.14
4.2.1. Distribution of the scores obtained from the three tests on subjective sleep quality The mean global sleep quality scores for the pretest, posttest, and follow-up test were 9.76, 8.38, and 7.86 respectively for the experimental group, and 10.20, 10.07, and 8.90 respectively for the control group. These results all showed poor sleep quality, but also revealed a gradual improvement in the experimental group's overall scores. Concerning the participants' subjective perception of sleep quality, the experimental group scored a mean of 2.03, 1.38, and 1.28 on the three tests, indicating that their subjective perception of sleep quality had improved from poor to good (Table 2).
1.07
.40
1.36
2.04
*p b .05.
employed to examine the homogeneity between groups based on their demographic characteristics and the baseline data derived from sleep quality. Generalized estimating equation was used to test the effects of the intervention on sleep quality. A p value of .05 was considered statistically significant. During the intervention process, participants from the experimental group indicated they had encountered a number of unexpected events. To reduce the effects of these confounding factors on the research results, each of these unexpected events was quantified and used the logistic regression model to calculate the probabilities of the posttest and follow-up test. After reorganizing these data, the propensity scores were obtained by conducting an inverse probability method, which were used as the control factor for data analysis. Propensity scores can be used to correct the bias caused by confounding factors in the observed results. By making adjustments using the propensity score, the dependent variable distribution allowed for random distribution, reducing the interference that covariance had on the research results, which established a causal relationship between the variables in the study (Quin, 2008).
4.2.2. Distribution of the scores obtained from objective sleep parameters The results showed that the mean score for sleep latency and percent of time awake decreased from 17.78 to 15.62 and from 13.33 to 10.65% respectively in the experimental group. Conversely, for the control group, the ratio of percent of time awake increased from 12.31 (pretest) to 13.22% (posttest), showing an upward growth. Regarding sleep efficiency, the experimental group scored 80.65 and 83.41% on the pretest and posttest respectively, whereas the control group scored 81.21 and 80.83% respectively (Table 3). 4.2.3. The effects of the improving sleep quality intervention on sleep disturbance After controlling the propensity score, the subjective sleep quality showed that no interaction was observed between the groups and time. However, a significant main effect in both variables, group and time, was found. Overall, the average score of the experimental group was 1.56 points better than the control group. Regarding the withintime effect, the average score of the experimental group was 1.47 points lower for the follow-up test than for the pretest. In terms of the objective sleep parameter, after controlling the propensity score, there was a significant difference in the interaction between time and group for the percent of time awake and sleep efficiency (Wald χ 2 = 10.15, p b .01; Wald χ 2 = 3.97, p b .05). Concerning sleep efficiency, the mean score of the experimental group surpassed that of the control group by 3.97 points (Table 4).
Table 2 Distribution of the scores obtained from the three tests on subjective sleep quality. Components
Experimental (n = 29) Baseline
Global score Subjective sleep quality Sleep latency (min) Sleep duration (hours) Sleep efficiency Sleep disturbances Use of sleeping medication Daytime dysfunction
Control (n = 30) Post test
Follow-up
Baseline
Post test
Follow-up
M
SD
M
SD
M
SD
M
SD
M
SD
M
SD
9.76 2.03 29 5.91 81.74 10.31 0.62 1.24
2.73 0.49 16.06 1.01 10.41 4.55 1.17 0.74
8.38 1.38 23.03 6.23 83.51 9.89 0.59 1.24
3.08 0.62 11.57 0.95 9.08 4.27 0.98 0.69
7.86 1.28 22.59 6.01 81.30 8.14 0.45 1.14
3.10 0.79 11.92 0.98 11.99 3.72 0.91 0.69
10.20 1.90 27.17 7.5 80.51 9.63 0.70 1.40
3.03 0.61 14.3 5.38 12.58 5.07 1.09 0.67
10.07 1.87 28.33 5.45 78.47 9.57 0.63 1.23
3.65 0.51 16.21 0.89 12.49 5.02 1.07 0.82
8.90 1.77 24.67 5.61 80.06 8.27 0.63 1.03
3.44 0.73 15.08 0.98 12.91 4.33 1.16 0.67
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Table 3 Distribution of the scores between obtained from objective sleep parameters. Experimental (n = 29)
Control (n = 30)
Pre Variables Onset latency (min) 0:≦15 1:16-30 2:31-60 3:N60 Sleep efficiency (%) 0:≧85 1:84–75 2:74–65 3:b65 WASO (min) Percentage(%) 0:≦15 1:16–30 2:31–60 3:N60 Snooze time (min) 0:≦15 1:16–30 2:31-60 3:N60 Total sleep time (hours) 0:N7 1:b6 ≦ 7 2:b5 ≦ 6 3:b5
n
Follow- up %
12 13 3 1
41.4 44.8 10.3 3.4
9 17 3 0
31.0 58.6 10.3 0
M
SD
17.78
14.51
80.65
54.87 13.3 1 2 14 12
3.4 6.9 48.3 41.4
19 7 2 1
65.5 24.1 6.9 3.4
2 14 11 2
6.9 48.3 37.9 6.9
16.11
6.04
n
%
18 6 5 0
62.1 20.7 17.2 0
14 11 4 0
48.3 37.9 13.8 0
4.84
Pre M
SD
15.62
15.33
83.41
21.06 4.23
43.77 10.65 0 7 18 4
0 24.1 62.1 13.8
18 10 1 0
62.1 34.5 3.4 0
5 10 10 4
17.2 34.5 34.5 13.8
17.59
14.14
.84
6.08
5. Discussion Regarding the participants' subjective sleep quality, no significant differences were found between the experimental and control groups as time passed. However, a between-group effect was found by further examining the main effect; the average global sleep quality score was lower for the experimental group than the control group. A time effect was also observed, where the average follow-up test score was lower than it was for the pretest in the experimental group. Additionally, concerning the objective sleep quality parameters obtained from the Actiwatch, some results found the following: in terms of waking up from sleep (in percentages) and sleep efficiency, there were significant differences in the interaction effect between the two groups and time, showing that the intervention exhibited a favorable effect on the experimental group's percent of time awake frequency and sleep efficiency. The sleep parameter showed that waking up from sleep (in percentages) and total awake time are extremely high for the participants. This finding was similar to a survey conducted by Shin et al. (2005) on sleep disturbance based on 2497 middle-aged Korean women that showed the most common disturbances were difficulty falling asleep, waking up at night, and waking up early, where waking up at night accounted for the disturbance with the highest proportion. Regarding total awake time at night, the participants in the experimental group reported 47 and 36 minutes in the pretest and follow-up test, respectively. Conversely, the control group reported 43 and 46 minutes in the pretest and follow-up test, respectively. These results indicate that the total awake time ratio and frequency were higher for the control group than for the experimental group. By significantly lowering the waking up from sleep frequency, the total sleep time undoubtedly increased and sleep quality was improved. It was found that participants in both the experimental group and the control group were recognized as poor sleepers. A progressive score reduction was observed in the experimental group, indicating sleep quality improvement. Qualitative information from this current study showed that progressive muscle relaxation has a favorable effect on participants suffering from a long-term inability to fall asleep.
n
Follow- up %
M 15.20
19 7 3 1
63.3 23.3 10 3.3
13 12 4 1
43.3 40.0 13.3 3.3
5.82
81.21
16.60 3.89
49.23 12.31 0 7 14 9
0 23.3 46.7 30
21 4 3 2
70 13.3 10 6.7
2 12 12 4
6.7 40 40 13.3
12.45
16.87
1.00
5.86
SD
n
%
5.11 23 4 2 1
76.7 13.3 6.7 3.3
16 9 4 1
53.3 30 13.3 3.3
6.79
23.93 5.11 2 5 19 4
6.7 16.7 63.3 13.3
21 7 2 0
70 23.3 6.7 0
4 10 12 4
13.3 33.3 40 13.3
18.70
.97
M
SD
13.07
14.34
80.83
7.11
48.86 13.22
28.82 5.78
13.37
10.66
5.89
1.03
Some of our participants even indicated that they had fallen asleep prior to finishing the CD. This finding suggests that the progressive muscle relaxation technique can be viewed as a crucial method in helping women go to sleep. However, in spite of this discovery, the diversified stress-relieving sleep-improvement program was unable to create significant changes in the participants' overall sleep quality parameters, which could possibly be due to the following reasons. First, it could be attributed to the insufficient statistical power that resulted in poor between-group effects. A sample size estimate prior to the intervention by setting α, power, and the Cohen's rule effect size at .05, 0.8, and 0.3, respectively, obtained an estimated ideal sample size of 62. Combined with the expected participant attrition rate of 20%, the sample size was 74. A total of 84 participants were recruited from a health seminar and volunteered to participate in this study. However, because a number of participants failed to meet the inclusion criteria or ultimately refused to participate in this study, the final number of participants was 59. By analyzing the numerical values consisting of the number of participants within each group, the ratio between β and α, the mean and standard deviation of sleep-quality score in the follow-up test, the power and effect size were reduced 51% and 0.17, respectively. The 0.17 effect size indicated the effectiveness of the intervention had been overestimated in this study. Additionally, the low sample size had engendered a low statistical power, resulting in difficulties detecting the effects of the intervention. The second reason was inadequate intervention duration and exercise intensity. Winbush, Gross, and Kreitzer (2007) pointed out that when using cognitive behavioral therapy as the intervention for improving sleep quality, it must be continued for at least 8 weeks to show a significant effect. In this study, an 8-week long stress-relieving intervention was performed to improve the sleep quality of menopausal women. The results were similar to the findings of Elavsky and McAuley (2007), who investigated the sleep quality of 164 middle-aged women who engaged in low-intensity exercises for 4 months. Elavsky and McAuley concluded that interventions through low-intensity exercises may be unable to effectively reduce the sleep disturbances experienced by women. Conversely, other research has shown that higher intensity
H-C. Hsu et al. / Applied Nursing Research 28 (2015) 374–380 Table 4 The effects of intervention on subjective and objective sleep quality of participants. Parameter PSQI(subjective sleep quality) Intercept Group Intervention vs. control Time T2 vs. T1 T3 vs. T1 Group × time Actigraphy Sleep onset latency (intercep) Group Intervention vs. control Time T3 vs. T1 Group × time Percent wake (intercep) Group Intervention vs. control Time T3 vs. T1 Group × time Sleep efficiency (intercep) Group Intervention vs. control Time T3 vs. T1 Group × time Snooze time (intercep) Group Intervention vs. control Time T3 vs. T1 Group × time Total sleep time (intercep) Group Intervention vs. control Time T3 vs. T1 Group × time
Β
SE
Ζ
p-Value 18.37
379
stress-relieving exercises and listening to the muscle relaxation CDs, I am now able to fall asleep quicker and do not get that much of a headache when I wake up. Most importantly, I no longer have to use these hypnotic drugs.”
b.01
11.78
2.74
−1.56
0.72
4.74⁎
−0.66 −1.47 −0.48
0.38 0.38 0.43
3.02 14.87⁎⁎ −1.35
15.48
11.22
1.83
.17
2.65
3.99
0.44
.51
−0.58 −1.60 12.57
3.58 4.84 1.80
0.03 0.11 48.87
1.19
1.20
0.97
−0.85 −3.66 78.49
0.61 1.14 2.84
1.96 10.15⁎⁎ 766.16
−0.63
1.50
0.18
−1.19 3.97 26.34
1.64 1.95 6.81
0.53 4.13⁎ 14.94
−2.84
4.06
0.49
0.49
−0.63 −1.37 345.83
4.56 5.48 24.27
0.02 0.07 202.98
.89 .80 b.01
10.33
14.22
0.53
.47
0.43 1.59
9.83 13.98
0.00 .01
.96 .90
.03 .08 b.01 .27
.87 .72 b.01 .32 .16 b.01 p b .01 .68 .47 .04 b.001
⁎ p b .05. ⁎⁎ p b .01.
exercises and extended intervention durations can help improve the sleep quality of menopausal women (Mansikkamäki et al., 2012; Yeh & Chang, 2012). Mansikkamäki et al. (2012) found significant differences in the sleep quality of women who engaged in high-intensity exercises (i.e., aerobic training or speed walking) for 6 months than in those who did not engage in any exercise. Therefore, extending the follow-up time and increasing the exercise intensity were recommended to enable the intervention to exhibit significant effects. The participants' compliance was another reason for a decrease in the effect of the intervention in this current study. Previous experimental, intervention-based studies have shown that when participant compliance decreases over time, the internal validity of the study also decreases. It may even result in the underestimation of the effectiveness of the intervention (Manocha et al., 2007). Because of this, it is reasonable to infer that only a small improvement was observed in our participants' subjective sleep quality from the pretest to the follow-up test due to a low compliance rating. The investigator used the information recorded in the Intervention Strategy At-Home Practice Log to calculate the participants' exercise-compliance ratings, where the average was recorded at 44%. Overall, the average daily exercise time for the experimental group was approximately 15 minutes. Finally, participants who occasionally used hypnotic drugs were also used in this study. The results showed that by adopting the sleep quality intervention, the drug use frequency decreased and sleep quality improved. For example, during the last lesson, one participant said, “I used to have to use hypnotic drugs three to four times a week; however, after practicing
5.1. Study limitation In traditional Chinese families, women of menopausal age have various responsibilities such as serving their in-laws, caring for their husbands and children, and housekeeping. In addition, when family members face unexpected events, these women are ultimately the ones who must help out the most. All of these responsibilities result in poor sleep quality. During the intervention process of this study, several experimental participants faced various unexpected events such as a husband being diagnosed with stage 4 liver cancer, a father-in-law being hospitalized, a husband suffering from a sudden stroke, and a husband having business problems. All of these directly and indirectly influenced the effectiveness of the intervention. 6. Conclusion The results of this study showed that the improving sleep quality intervention exhibited a significantly positive effect on the percent of time awake and sleep efficiency of participants in the experimental group. Although no significant improvements were observed in participants' subjective sleep quality after the implementation of the 8-week intervention, the results did demonstrate a positive and progressive change, indicating clinical applicability. It is strongly recommended to increase the sample size, prolong the intervention duration, and increase the exercise intensity in future studies to facilitate the effectiveness of intervention. Finally, the findings of this study shown that the improving sleep quality intervention may act as a non-pharmacological method to alleviate sleep disturbances in menopausal women. Hence Health care professionals can provide the simple, feasible, safe, and cost-effective selfrelaxation intervention to those menopausal women who face multiple phenomenon causing sleep disorders to improve their sleep quality. References Adachi, Y., Sato, C., Kunitsuka, K., Hayama, J., & Doi, Y. (2008). A brief behavior therapy administered by correspondence improves sleep and sleep-related behavior in poor sleepers. Sleep and Biological Rhythms, 6, 16–21. Bandura, A. (1986). Social foundations of thought and action: A social cognitive theory. Englewood Cliffs, NJ: Prentice-Hall. Cardoso, R., Souza, E., Camano, L., & Leite, J. R. (2004). Meditation in health: an operational definition. Brain Research Protocols, 14, 58–60. Consolo, K., Fusner, S., & Staib, S. (2008). Effects of diaphragmatic breathing on stress levels of nursing students. Teaching and Learning in Nursing, 3, 67–71. Eichling, P. S., & Sahni, J. (2005). Menopause related sleep disorders. Journal of Clinical Sleep Medicine, 1(3), 291–300. Elavsky, S., & McAuley, E. (2007). Lack of perceived sleep improvement after 4-month structured exercise programs. Menopause, 14(Pt 1), 535–540. Freedman, R. R., & Reohrs, T. A. (2005). Lack of sleep disturbance from menopausal hot flashes. Fertility and Sterility, 82(1), 138–145. Ghoncheh, S., & Smith, J. C. (2004). Progressive muscle relaxation, Yoga Stretching, and ABC relaxation theory. Journal of Clinical Psychology, 60(1), 131–136. Kaul, P., Passafiume, J., Sargent, R. C., & O'Hara, B. F. (2010). Meditation acutely improves psychomotor vigilance, and may decrease sleep need. Behavioral and Brain Functions, 6(47), 1–9, http://dx.doi.org/10.1186/1744-9081-6-47. Kwekkeboom, K. L., & Gretarsdottir, E. (2006). Systematic review of relaxation interventions for pain. Journal of Nursing Scholarship, 38(3), 269–277. Lynch, A. M., Jarvis, C. I., Debellis, R. J., & Morin, A. K. (2007). Nonpharmacologic approaches for the treatment of insomnia. American Journal of Lifestyle Medicine, 1(4), 274–282, http://dx.doi.org/10.1177/1559827607301. Manocha, R., Semmar, B., & Black, D. (2007). A pilot study of a mental silence from of meditation for women in perimenopause. Journal of Clinical Psychology in Medical Settings, 14, 266–273. Mansikkamäki, K., Raitanen, J., Nygård, C. H., Heinonen, R., Mikkola, T., Tomás, E., et al. (2012). Sleep quality and aerobic training among menopausal women—A randomized controlled trial. Maturitas, 72(4), 339–345, http://dx.doi.org/10.1016/j.maturitas.2012. 05.003 (Epub 2012 Jun 4).
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Moilanen, J., Aalto, A., Hemminki, E., Aro, A., Ratitanen, J., & Luoto, R. (2010). Prevalence of menopause symptoms and their association with lifestyle among Finnish middleaged women. Maturitas, 67, 368–374. Ong, J. C., Shapiro, S. L., & Manber, R. (2008). Combining mindfulness meditation with cognitive–behavior therapy for insomonia: A treatment-development study. Behavior Therapy, 39, 171–182. Ong, J. C., Shapiro, S. L., & Manber, R. (2009). Mindfulness meditation and cognitive behavioral therapy for insomnia: A naturalistic 12-month follow-up. The Journal of Science and Healing, 5(1), 30–36, http://dx.doi.org/10.1016/j.explore.2008.10.004. Quin, R. (2008). Estimating effects of nursing iIntervention via propensity score analysis. Nursing Research, 57(6), 444–452. Rausch, S. M., Gramling, S. E., & Auerbach, S. M. (2006). Effects of a single session of largegroup meditation and progressive muscle relaxation training on stress reduction, reactivity, and recovery. International Journal of Stress Management, 13(3), 273–290. Senba, N., & Matsuo, H. (2010). Effect of a health education program on climacteric women. Climacteric, 13, 561–569.
Shin, C., Lee, S., Lee, T., Shin, K., Yi, H., Kimm, K., et al. (2005). Prevalence of insomnia and its relationship to menopausal status in middle-aged Korean women. Psychiatry and Clinical Neurosciences, 59, 395–402. Tsai, P. S., Wang, S. Y., Wang, M. Y., Su, C. T., Yang, T. T., Haung, C. J., et al. (2005). Psychometric evaluation of the Chinese version of the Pittsburgh Sleep QualityIndex (CPSQI) in primary insomnia and control subjects. Quality of Life Research, 14, 1943–1952. Winbush, N. Y., Gross, C. R., & Kreitzer, M. J. (2007). The effects on mindfulness-based stress reduction on sleep disturbance: a systematic review. Explore, 3(6), 585–591. Woods, N. F., & Mitchell, E. S. (2005). Symptoms during the perimenopause: Prevalence, severity, trajectory, and significance in women’s lives. The American Journal of Medicine, 118, 14–24. Yeh, S. C., & Chang, M. -Y. (2012). The effect of Qigong on menopausal symptoms and quality of sleep for perimenopausal women: A preliminary observational study. The Journal of Alternative and Complementary Medicine, 18(6), 567–575, http://dx.doi. org/10.1089/acm.2011.0133.
Contents lists available at ScienceDirect
Applied Nursing Research journal homepage: www.elsevier.com/locate/apnr
Original Article
Improving sleep quality interventions among menopausal women with sleep disturbances in Taiwan: a preliminary study Hsiu-Chin Hsu, PhD, RN a, Lee-Ing Tsao, DNSc b, Mei-Hsiang Lin, EdD, RN b,⁎ a b
Department of Nursing Chang Gung University of Science and Technology, Taiwan, ROC National Taipei University of Nursing and Health Science, Taipei, Taiwan
a r t i c l e
i n f o
Article history: Received 1 September 2014 Revised 17 January 2015 Accepted 24 January 2015 Available online xxxx Keywords: Sleep quality Menopause Improving sleep quality intervention Actiwatch
a b s t r a c t Aim: The aim of this study was to evaluate the effectiveness of improving sleep quality interventions in menopausal women with sleep disturbance. Background: Sleep disturbances are an extensive and common problem among menopausal women. There is an increased trend in the use of non-pharmacological methods to alleviate sleep disturbances. Studies that have implemented two or more non-pharmacological strategies for menopausal women are scant. Methods: A repeat measurement with a randomized assignment was conducted. A total of 59 menopausal women with sleep disturbance were recruited and randomly assigned to experimental (n = 29) and control (n = 30) groups. Participants in the experimental group received four 2-hour improving sleep quality activities, whereas the control group received regular greeting calls. Sleep quality was measured prior to intervention, and on the 5th and 8th weeks by using the Pittsburg’s Sleep Quality Index, and Actiwatch was worn before and during the 8 weeks of intervention. Generalized estimating equation was used to analyze data. Results: The results revealed that subjective sleep quality had significant main effect in group and time. The findings of the objective measurement showed that participants in the experimental group had significantly shorter frequency of awakening time and increased sleep efficiency. Conclusion: The improving sleep quality intervention is a healthy and cost-effective method to improve sleep quality in community-dwelling menopausal women with sleep disturbance. © 2015 Elsevier Inc. All rights reserved.
1. Introduction Menopausal women face a crucial transitional time in life. During this period, women undergo substantial biological, psychological, and social changes. This includes gradual physiological degeneration, with a considerable decrease in the production of sleep quality-regulating hormones such as estrogen and progesterone. In addition, because women have different social and cultural expectations than men (Senba & Matsuo, 2010), the multi-faceted phenomenon produces changes in the sleep-controlling neuroendocrine system, causing sleep disorders (Manocha, Semmar, & Black, 2007). Studies done on the prevalence of menopausal symptoms have reported that approximately 20 to 60% of menopausal women complain about having sleep disorders (Eichling & Sahni, 2005; Moilanen et al., 2010; Woods & Mitchell,
Funding: This study was supported by the grant from Chang Gung Medical Foundation, Taiwan, ROC (no. CMRPF1A0081). Conflict of interest: No conflict of interest had been declared by the authors. Authors' contribution: HH-C was responsible for the study conception and design. HHC was responsible drafting of the manuscript. HH-C, LM-H and Tsao L-I made critical revisions to the paper for important intellectual content. ⁎ Corresponding author at: No.365, Ming-te Road, Peitou District, Taipei City, Taiwan, ROC. Tel.: + 886 2 28227101. E-mail addresses: [email protected] (H.-C. Hsu), [email protected] (L.-I. Tsao), [email protected] (M.-H. Lin). http://dx.doi.org/10.1016/j.apnr.2015.01.004 0897-1897/© 2015 Elsevier Inc. All rights reserved.
2005), indicating the prevalence and severity of sleep-related problems. It is extremely crucial to care for the health of menopausal women because menopausal women with long-term sleep disturbances will ultimately exhibit comparatively poorer physiological and mental health and a deteriorating quality of life. These problems initiate a vicious cycle that will negatively impact the quality of their life in later years. In recent years, studies on improving the sleep quality of menopausal women have garnered increased attention. Ong, Shapiro, and Manber (2008) indicated an increased trend in the use of non-pharmacological methods to alleviate sleep disturbances. It is generally believed that the combined use of multiple behavioral techniques to improve sleep quality is more effective than a single technique. However, current solutions introduced in most studies employ only a single intervention to improve the sleep disturbance experienced by menopausal women (Elavsky & McAuley, 2007; Senba & Matsuo, 2010). Studies that have implemented two or more intervention strategies are scant. When considering the intervention strategies used to improve the sleep quality of menopausal women, these strategies must also reduce the pressure that menopausal women experience because of both physiological and mental changes, while easing the sleep problems caused by neuroendocrine changes. Therefore, a set of strategies to improve sleep quality primarily focused on reducing pressure by engaging in self-relaxation exercises was used in this study. The strategies included stressrelieving low-intensity exercises, meditation with diaphragmatic
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breathing, progressive muscle relaxation, and sleep hygiene education. These approaches were modeled on some previous studies which have found significantly reducing the level of nervous tension (Kaul, Passafiume, Sargent, & O'Hara, 2010). Notably, the social cognitive theory is a useful behavioral theory to improve health care outcomes (Bandura, 1986). Therefore, the intervention was informed by the social cognitive theory to improve the sleep quality of menopausal women. 2. Background Meditation is used to train individuals to focus on a single object, voice, or experience (Cardoso, Souza, Camano, & Leite, 2004). By meditating, the awareness of the body is lowered, the intensity of the circulating hormones created by pressure is changed, and the activities associated with the sympathetic nervous system, such as the beating of the heart, breathing, and hot flashes are reduced. In addition, by correctly and continuously practicing meditation, individuals can enhance the α wave in their brain, which eliminates worry and reduces tension. This achieves mental stability and enhances sleep quality (Kaul et al., 2010, Manocha et al., 2007). A number of sleep-related studies have used meditation as the intervention strategy to help people with sleep disorders. Results showed a significant decrease in total awake time during the night, which improved sleep efficiency and sleep quality (Ong et al., 2008, Ong, Shapiro, & Manber, 2009). The efficacy of stress-relieving exercises to reduce pressure and divert attention away from stressful events has been extensively documented (Ghoncheh & Smith, 2004; Kwekkeboom & Gretarsdottir, 2006). The exercises primarily entail the stretching of selected muscles to a maximum distance before holding still for 10 seconds and then slowly relaxing each muscle. Concurrently, the individuals rhythmically breathe in and out to produce anxiety-diversion and pressurereduction effects. Moreover, diaphragmatic breathing has long been considered the simplest and easiest technique to learn. By engaging in diaphragmatic breathing, the parasympathetic nervous system is excited and physiological and mental stimulations are reduced, immediately achieving the effect of pressure reduction when stressful events are forthcoming (Consolo, Fusner, & Staib, 2008; Kwekkeboom & Gretarsdottir, 2006). Regarding the progressive muscle relaxation technique, it has also been proven by empirical studies to have a multileveled positive effect on people experiencing physical and psychological discomfort (Rausch, Gramling, & Auerbach, 2006). The progressive muscle relaxation technique primarily involves the gradual tightening of the muscles from head to toe for 15 seconds and then the relaxation of the muscles for approximately 30 seconds. This technique can help control anxiety and create a physiological hypo-arousal effect (Rausch et al., 2006). Furthermore, sleep hygiene can help individuals with insomnia identify appropriate ways to correct their lifestyle choices and improve their sleep quality (Lynch, Jarvis, DeBellis, & Morin, 2007). Adachi, Sato, Kunitsuka, Hayama, and Doi (2008) conducted a longitudinal study and follow-up with the participants 1 year after the experiment also showed substantial sleep quality improvement. Thus, Adachi et al. recommended sleep hygiene education to encourage people to change unhealthy behaviors for improving their sleep quality. The purpose of this study was to evaluate the effects of improving sleep quality intervention on sleep disturbance through subjective and objective parameters in menopausal women. It was expected that menopausal women receiving interventions would experience enhanced sleep quality. 3. Methods 3.1. Design This study adopted a repeat measurement with a randomized assignment and a controlled trial. Sixty-three participants were
375
randomly assigned into two groups in a 1:1 ratio by neighborhood to avoid diffusion of treatment effect. The investigator drew from two sealed envelopes determining which participants would be in the experimental group and which in the control group. The experimental group received four 2-hour sleep quality-improvement intervention activities whereas the control group received only regular care or greeting calls. Upon completing these activities, the same sleep intervention teaching materials were given to the control group. The investigator explained the results of the sleep data of each participant that was collected from three questionnaires and two sleep-recording watches. 3.2. Participants Menopausal women with sleep disturbance were recruited from one of the townships in Central Taiwan. The GPower3.05 software was used to estimate the sample size and perform statistical tests on the two groups through ANOVA-repeat measure-between factors. The value of α, power, Cohen's rule effect size, and a medium autocorrelation were set at 0.05, 0.8, 0.3, and 0.5 respectively. An ideal sample size was 62, with each group comprising 31 members. By conducting a women's health lecture, posting flyers, and receiving referrals, 84 volunteers who were community-dwelling menopausal women were recruited. After removing 21 participants who failed to satisfy our inclusion criteria, the final number of participants was 63. Inclusion criteria were: (1) be between 45 and 60 years of age, (2) experience sleep difficulty for at least 3 days a week over the past month, (3) have a total score higher than five on the Pittsburg sleep quality index, (4) have no mental illness or severe illness such as cancer, heart disease, or lung disease, and (5) be willing to participate in an 8-week intervention activity. Exclusion criteria were: (1) have a habit of using sedatives, hypnotic drugs, or hormone medication, and (2) attend or are still attending sleep improvement-related lessons within the past 6 months. During the intervention period, three participants from the experimental group and one from the control group had to drop out of the study. Therefore, the remaining participants in the experimental and control groups successfully completing the study were 29 and 30, respectively (Fig. 1). 3.3. Intervention The theoretical framework for intervention program which primarily focused on reducing stress and promoting self-relaxation was based on the social cognitive theory. In the first lesson, the investigator introduced information concerning menopausal women with sleep disturbance and explained the sleep-improvement intervention program. In the second lesson, the participants were taught eight stress-relieving exercises, followed by meditation and learning how to focus on diaphragmatic breathing. A stress-relieving exercise expert was invited to the lesson for guidance and consultation. Lecture notes containing the program content were provided to each participant, including a reminder to practice at home at least 30 minutes daily. Next, the investigator made an Intervention At-Home Practice Log and required each participant to set goals and self-monitor their practice time, frequency, and any difficulties they experienced as references for assessment as well as solve problems. In the third lesson, the participants were divided into groups containing three to five members. During the lesson, the progressive muscle relaxation video was played to teach the participants how to relax their muscles and instruct them on how to duplicate the movements they heard on the CD. Additionally, the investigator provided the participants with a progressive muscle relaxation CD. The CD taught them how to lie still in bed 30 minutes before going to sleep by following the instructions to slowly relax and guide themselves to sleep. In the fourth lesson, the investigator gave each group a sleep hygiene education booklet. These provided them with information that could improve
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Fig. 1. Trial Profile.
their sleep quality. During these lessons, the participants were motivated to share their experiences and receive answers to their questions. A discussion time was allotted at the end of each of the four lessons to encourage the participants to ask questions pertaining to the lesson or to share their ideas. At the same time, the researcher asked the participants to complete the program and continually provided positive reinforcement of crucial behaviors. The purposes of these sessions were provided opportunities for observational learning, goal-setting, selfmonitoring, and social support from the social cognitive theory to help participants obtaining related behaviors (mediation and exercises). Consequently the pressure was reduced by performing the behaviors and the quality of sleep was improved. 3.4. Data collection Prior to conducting the intervention activities, each individual was required to fill out the questionnaires to build the baseline data. Concurrently, the participants were asked to wear a sleep-recording watch called Actiwatch. To prevent inconsistencies in watch-wearing time because of varying levels of activity during weekdays and weekends, the participants were instructed to wear the watch between Monday and Thursday. Considering the possibility of underestimated sleep quality on the first night, the participants were asked to wear the Actiwatches for two consecutive days (Freedman & Reohrs, 2004). Finally, the investigator reaffirmed to the participants that in weeks 5 and 8a trained research assistant would collect their subjective sleep-related data and ask the participants to wear the Actiwatch again in week 8. 3.5. Instruments validity and reliability The CPSQI contains 19 questions divided into seven major components: sleep latency, subjective sleep quality, sleep duration, sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. A score of zero to three was assigned to each component and each participant could get a global score of zero to
twenty-one. Higher scores indicated poorer sleep quality and participants with a global score higher than five were considered to have poor sleep quality. Regarding the reliability of the CPSQI, it showed an internal consistency and split-half reliability of 0.82–0.83 and 0.94, respectively (Tsai et al., 2005). In this study, the pilot study showed the Cronbach's α was 0.75, and the formal study demonstrated the Cronbach's α was 0.70. The Actiwatch is a wristwatch-sized device that has been widely used in clinical practice and research to investigate sleeping problems. The validity of the Actiwatch has been confirmed by using the polysomnography to distinguish between being asleep and being awake. Concurrently, the reliability of the Actiwatch exhibited a correlation coefficient of 0.88 with polysomnography. In this study, the Actiwatch-64 produced by the Mini Mitter Company was employed (2005) to objectively assess the sleep quality of menopausal women. The indices included sleep latency (the time it took for them to shut off the light and fall asleep), snooze time (the time it took for them to get out of bed after waking up), sleep efficiency (the ratio between the time they were fully asleep and the total time they spent in bed, multiplied by 100), the percent they were awake (the ratio between the total awake time at night and the total sleep time, multiplied by 100), and the total sleep time (the period between the time that they climbed into bed and the time they got out of bed). 3.6. Ethical considerations The original study protocol was approved by the Institutional Review Board of the appropriate university. All the participants received a detailed explanation regarding the study and all signed informed consent forms. 3.7. Data analysis SPSS 15.0 for Windows was used for data analyses. A t test for independent samples, chi-squared test, and Fisher's exact test were
H-C. Hsu et al. / Applied Nursing Research 28 (2015) 374–380
4. Results
Table 1 Baseline characteristics of the study participants. Experimental (n = 29) n Age Menopausal status Pre-menopause Peri-menopause Post-menopause Employment No Yes Hypnotic use No Yes Education Elementary or illiterate Junior or senior high school Above college Marital status Married Divorced Widowed Single Exercise No Yes Chronic disease No Yes
%
29
377
Control (n = 30)
Mean
SD
n
%
49.52
4.03
30
13 10 6
44.8 34.5 20.7
10 9 11
33.3 30.0 36.7
6 23
20.7 79.3
2 28
6.7 93.3
21 8
72.4 27.6
23 7
76.7 23.3
2
6.9
1
3.3
21
72.4
25
83.3
6
20.7
4
13.3
22 3 2 2
75.9 10.3 6.9 6.9
24 3 1 2
80.0 10.0 3.3 6.7
15 14
51.7 48.3
20 10
66.7 33.3
14 15
48.3 51.7
20 10
66.7 33.3
Mean
SD
49.57
3.41
4.1. Characteristics of the participants
t/χ2/ Fisher's exact
A total of 59 women fully participated in this study. The experimental group was composed of 29 members with an average age of 49.52 (SD 4.03); the control group consisted of 30 members with an average age of 49.57 (SD 3.41). The baseline characteristics of the two groups did not exhibit significant differences (Table 1). Moreover, there was no significant difference in the baseline subjective sleep parameter between two groups. (t = −0.59, p = .56).
−.51 .1.89
2.43
4.2. The effects of the intervention on sleep quality
.14
4.2.1. Distribution of the scores obtained from the three tests on subjective sleep quality The mean global sleep quality scores for the pretest, posttest, and follow-up test were 9.76, 8.38, and 7.86 respectively for the experimental group, and 10.20, 10.07, and 8.90 respectively for the control group. These results all showed poor sleep quality, but also revealed a gradual improvement in the experimental group's overall scores. Concerning the participants' subjective perception of sleep quality, the experimental group scored a mean of 2.03, 1.38, and 1.28 on the three tests, indicating that their subjective perception of sleep quality had improved from poor to good (Table 2).
1.07
.40
1.36
2.04
*p b .05.
employed to examine the homogeneity between groups based on their demographic characteristics and the baseline data derived from sleep quality. Generalized estimating equation was used to test the effects of the intervention on sleep quality. A p value of .05 was considered statistically significant. During the intervention process, participants from the experimental group indicated they had encountered a number of unexpected events. To reduce the effects of these confounding factors on the research results, each of these unexpected events was quantified and used the logistic regression model to calculate the probabilities of the posttest and follow-up test. After reorganizing these data, the propensity scores were obtained by conducting an inverse probability method, which were used as the control factor for data analysis. Propensity scores can be used to correct the bias caused by confounding factors in the observed results. By making adjustments using the propensity score, the dependent variable distribution allowed for random distribution, reducing the interference that covariance had on the research results, which established a causal relationship between the variables in the study (Quin, 2008).
4.2.2. Distribution of the scores obtained from objective sleep parameters The results showed that the mean score for sleep latency and percent of time awake decreased from 17.78 to 15.62 and from 13.33 to 10.65% respectively in the experimental group. Conversely, for the control group, the ratio of percent of time awake increased from 12.31 (pretest) to 13.22% (posttest), showing an upward growth. Regarding sleep efficiency, the experimental group scored 80.65 and 83.41% on the pretest and posttest respectively, whereas the control group scored 81.21 and 80.83% respectively (Table 3). 4.2.3. The effects of the improving sleep quality intervention on sleep disturbance After controlling the propensity score, the subjective sleep quality showed that no interaction was observed between the groups and time. However, a significant main effect in both variables, group and time, was found. Overall, the average score of the experimental group was 1.56 points better than the control group. Regarding the withintime effect, the average score of the experimental group was 1.47 points lower for the follow-up test than for the pretest. In terms of the objective sleep parameter, after controlling the propensity score, there was a significant difference in the interaction between time and group for the percent of time awake and sleep efficiency (Wald χ 2 = 10.15, p b .01; Wald χ 2 = 3.97, p b .05). Concerning sleep efficiency, the mean score of the experimental group surpassed that of the control group by 3.97 points (Table 4).
Table 2 Distribution of the scores obtained from the three tests on subjective sleep quality. Components
Experimental (n = 29) Baseline
Global score Subjective sleep quality Sleep latency (min) Sleep duration (hours) Sleep efficiency Sleep disturbances Use of sleeping medication Daytime dysfunction
Control (n = 30) Post test
Follow-up
Baseline
Post test
Follow-up
M
SD
M
SD
M
SD
M
SD
M
SD
M
SD
9.76 2.03 29 5.91 81.74 10.31 0.62 1.24
2.73 0.49 16.06 1.01 10.41 4.55 1.17 0.74
8.38 1.38 23.03 6.23 83.51 9.89 0.59 1.24
3.08 0.62 11.57 0.95 9.08 4.27 0.98 0.69
7.86 1.28 22.59 6.01 81.30 8.14 0.45 1.14
3.10 0.79 11.92 0.98 11.99 3.72 0.91 0.69
10.20 1.90 27.17 7.5 80.51 9.63 0.70 1.40
3.03 0.61 14.3 5.38 12.58 5.07 1.09 0.67
10.07 1.87 28.33 5.45 78.47 9.57 0.63 1.23
3.65 0.51 16.21 0.89 12.49 5.02 1.07 0.82
8.90 1.77 24.67 5.61 80.06 8.27 0.63 1.03
3.44 0.73 15.08 0.98 12.91 4.33 1.16 0.67
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Table 3 Distribution of the scores between obtained from objective sleep parameters. Experimental (n = 29)
Control (n = 30)
Pre Variables Onset latency (min) 0:≦15 1:16-30 2:31-60 3:N60 Sleep efficiency (%) 0:≧85 1:84–75 2:74–65 3:b65 WASO (min) Percentage(%) 0:≦15 1:16–30 2:31–60 3:N60 Snooze time (min) 0:≦15 1:16–30 2:31-60 3:N60 Total sleep time (hours) 0:N7 1:b6 ≦ 7 2:b5 ≦ 6 3:b5
n
Follow- up %
12 13 3 1
41.4 44.8 10.3 3.4
9 17 3 0
31.0 58.6 10.3 0
M
SD
17.78
14.51
80.65
54.87 13.3 1 2 14 12
3.4 6.9 48.3 41.4
19 7 2 1
65.5 24.1 6.9 3.4
2 14 11 2
6.9 48.3 37.9 6.9
16.11
6.04
n
%
18 6 5 0
62.1 20.7 17.2 0
14 11 4 0
48.3 37.9 13.8 0
4.84
Pre M
SD
15.62
15.33
83.41
21.06 4.23
43.77 10.65 0 7 18 4
0 24.1 62.1 13.8
18 10 1 0
62.1 34.5 3.4 0
5 10 10 4
17.2 34.5 34.5 13.8
17.59
14.14
.84
6.08
5. Discussion Regarding the participants' subjective sleep quality, no significant differences were found between the experimental and control groups as time passed. However, a between-group effect was found by further examining the main effect; the average global sleep quality score was lower for the experimental group than the control group. A time effect was also observed, where the average follow-up test score was lower than it was for the pretest in the experimental group. Additionally, concerning the objective sleep quality parameters obtained from the Actiwatch, some results found the following: in terms of waking up from sleep (in percentages) and sleep efficiency, there were significant differences in the interaction effect between the two groups and time, showing that the intervention exhibited a favorable effect on the experimental group's percent of time awake frequency and sleep efficiency. The sleep parameter showed that waking up from sleep (in percentages) and total awake time are extremely high for the participants. This finding was similar to a survey conducted by Shin et al. (2005) on sleep disturbance based on 2497 middle-aged Korean women that showed the most common disturbances were difficulty falling asleep, waking up at night, and waking up early, where waking up at night accounted for the disturbance with the highest proportion. Regarding total awake time at night, the participants in the experimental group reported 47 and 36 minutes in the pretest and follow-up test, respectively. Conversely, the control group reported 43 and 46 minutes in the pretest and follow-up test, respectively. These results indicate that the total awake time ratio and frequency were higher for the control group than for the experimental group. By significantly lowering the waking up from sleep frequency, the total sleep time undoubtedly increased and sleep quality was improved. It was found that participants in both the experimental group and the control group were recognized as poor sleepers. A progressive score reduction was observed in the experimental group, indicating sleep quality improvement. Qualitative information from this current study showed that progressive muscle relaxation has a favorable effect on participants suffering from a long-term inability to fall asleep.
n
Follow- up %
M 15.20
19 7 3 1
63.3 23.3 10 3.3
13 12 4 1
43.3 40.0 13.3 3.3
5.82
81.21
16.60 3.89
49.23 12.31 0 7 14 9
0 23.3 46.7 30
21 4 3 2
70 13.3 10 6.7
2 12 12 4
6.7 40 40 13.3
12.45
16.87
1.00
5.86
SD
n
%
5.11 23 4 2 1
76.7 13.3 6.7 3.3
16 9 4 1
53.3 30 13.3 3.3
6.79
23.93 5.11 2 5 19 4
6.7 16.7 63.3 13.3
21 7 2 0
70 23.3 6.7 0
4 10 12 4
13.3 33.3 40 13.3
18.70
.97
M
SD
13.07
14.34
80.83
7.11
48.86 13.22
28.82 5.78
13.37
10.66
5.89
1.03
Some of our participants even indicated that they had fallen asleep prior to finishing the CD. This finding suggests that the progressive muscle relaxation technique can be viewed as a crucial method in helping women go to sleep. However, in spite of this discovery, the diversified stress-relieving sleep-improvement program was unable to create significant changes in the participants' overall sleep quality parameters, which could possibly be due to the following reasons. First, it could be attributed to the insufficient statistical power that resulted in poor between-group effects. A sample size estimate prior to the intervention by setting α, power, and the Cohen's rule effect size at .05, 0.8, and 0.3, respectively, obtained an estimated ideal sample size of 62. Combined with the expected participant attrition rate of 20%, the sample size was 74. A total of 84 participants were recruited from a health seminar and volunteered to participate in this study. However, because a number of participants failed to meet the inclusion criteria or ultimately refused to participate in this study, the final number of participants was 59. By analyzing the numerical values consisting of the number of participants within each group, the ratio between β and α, the mean and standard deviation of sleep-quality score in the follow-up test, the power and effect size were reduced 51% and 0.17, respectively. The 0.17 effect size indicated the effectiveness of the intervention had been overestimated in this study. Additionally, the low sample size had engendered a low statistical power, resulting in difficulties detecting the effects of the intervention. The second reason was inadequate intervention duration and exercise intensity. Winbush, Gross, and Kreitzer (2007) pointed out that when using cognitive behavioral therapy as the intervention for improving sleep quality, it must be continued for at least 8 weeks to show a significant effect. In this study, an 8-week long stress-relieving intervention was performed to improve the sleep quality of menopausal women. The results were similar to the findings of Elavsky and McAuley (2007), who investigated the sleep quality of 164 middle-aged women who engaged in low-intensity exercises for 4 months. Elavsky and McAuley concluded that interventions through low-intensity exercises may be unable to effectively reduce the sleep disturbances experienced by women. Conversely, other research has shown that higher intensity
H-C. Hsu et al. / Applied Nursing Research 28 (2015) 374–380 Table 4 The effects of intervention on subjective and objective sleep quality of participants. Parameter PSQI(subjective sleep quality) Intercept Group Intervention vs. control Time T2 vs. T1 T3 vs. T1 Group × time Actigraphy Sleep onset latency (intercep) Group Intervention vs. control Time T3 vs. T1 Group × time Percent wake (intercep) Group Intervention vs. control Time T3 vs. T1 Group × time Sleep efficiency (intercep) Group Intervention vs. control Time T3 vs. T1 Group × time Snooze time (intercep) Group Intervention vs. control Time T3 vs. T1 Group × time Total sleep time (intercep) Group Intervention vs. control Time T3 vs. T1 Group × time
Β
SE
Ζ
p-Value 18.37
379
stress-relieving exercises and listening to the muscle relaxation CDs, I am now able to fall asleep quicker and do not get that much of a headache when I wake up. Most importantly, I no longer have to use these hypnotic drugs.”
b.01
11.78
2.74
−1.56
0.72
4.74⁎
−0.66 −1.47 −0.48
0.38 0.38 0.43
3.02 14.87⁎⁎ −1.35
15.48
11.22
1.83
.17
2.65
3.99
0.44
.51
−0.58 −1.60 12.57
3.58 4.84 1.80
0.03 0.11 48.87
1.19
1.20
0.97
−0.85 −3.66 78.49
0.61 1.14 2.84
1.96 10.15⁎⁎ 766.16
−0.63
1.50
0.18
−1.19 3.97 26.34
1.64 1.95 6.81
0.53 4.13⁎ 14.94
−2.84
4.06
0.49
0.49
−0.63 −1.37 345.83
4.56 5.48 24.27
0.02 0.07 202.98
.89 .80 b.01
10.33
14.22
0.53
.47
0.43 1.59
9.83 13.98
0.00 .01
.96 .90
.03 .08 b.01 .27
.87 .72 b.01 .32 .16 b.01 p b .01 .68 .47 .04 b.001
⁎ p b .05. ⁎⁎ p b .01.
exercises and extended intervention durations can help improve the sleep quality of menopausal women (Mansikkamäki et al., 2012; Yeh & Chang, 2012). Mansikkamäki et al. (2012) found significant differences in the sleep quality of women who engaged in high-intensity exercises (i.e., aerobic training or speed walking) for 6 months than in those who did not engage in any exercise. Therefore, extending the follow-up time and increasing the exercise intensity were recommended to enable the intervention to exhibit significant effects. The participants' compliance was another reason for a decrease in the effect of the intervention in this current study. Previous experimental, intervention-based studies have shown that when participant compliance decreases over time, the internal validity of the study also decreases. It may even result in the underestimation of the effectiveness of the intervention (Manocha et al., 2007). Because of this, it is reasonable to infer that only a small improvement was observed in our participants' subjective sleep quality from the pretest to the follow-up test due to a low compliance rating. The investigator used the information recorded in the Intervention Strategy At-Home Practice Log to calculate the participants' exercise-compliance ratings, where the average was recorded at 44%. Overall, the average daily exercise time for the experimental group was approximately 15 minutes. Finally, participants who occasionally used hypnotic drugs were also used in this study. The results showed that by adopting the sleep quality intervention, the drug use frequency decreased and sleep quality improved. For example, during the last lesson, one participant said, “I used to have to use hypnotic drugs three to four times a week; however, after practicing
5.1. Study limitation In traditional Chinese families, women of menopausal age have various responsibilities such as serving their in-laws, caring for their husbands and children, and housekeeping. In addition, when family members face unexpected events, these women are ultimately the ones who must help out the most. All of these responsibilities result in poor sleep quality. During the intervention process of this study, several experimental participants faced various unexpected events such as a husband being diagnosed with stage 4 liver cancer, a father-in-law being hospitalized, a husband suffering from a sudden stroke, and a husband having business problems. All of these directly and indirectly influenced the effectiveness of the intervention. 6. Conclusion The results of this study showed that the improving sleep quality intervention exhibited a significantly positive effect on the percent of time awake and sleep efficiency of participants in the experimental group. Although no significant improvements were observed in participants' subjective sleep quality after the implementation of the 8-week intervention, the results did demonstrate a positive and progressive change, indicating clinical applicability. It is strongly recommended to increase the sample size, prolong the intervention duration, and increase the exercise intensity in future studies to facilitate the effectiveness of intervention. Finally, the findings of this study shown that the improving sleep quality intervention may act as a non-pharmacological method to alleviate sleep disturbances in menopausal women. Hence Health care professionals can provide the simple, feasible, safe, and cost-effective selfrelaxation intervention to those menopausal women who face multiple phenomenon causing sleep disorders to improve their sleep quality. References Adachi, Y., Sato, C., Kunitsuka, K., Hayama, J., & Doi, Y. (2008). A brief behavior therapy administered by correspondence improves sleep and sleep-related behavior in poor sleepers. Sleep and Biological Rhythms, 6, 16–21. Bandura, A. (1986). Social foundations of thought and action: A social cognitive theory. Englewood Cliffs, NJ: Prentice-Hall. Cardoso, R., Souza, E., Camano, L., & Leite, J. R. (2004). Meditation in health: an operational definition. Brain Research Protocols, 14, 58–60. Consolo, K., Fusner, S., & Staib, S. (2008). Effects of diaphragmatic breathing on stress levels of nursing students. Teaching and Learning in Nursing, 3, 67–71. Eichling, P. S., & Sahni, J. (2005). Menopause related sleep disorders. Journal of Clinical Sleep Medicine, 1(3), 291–300. Elavsky, S., & McAuley, E. (2007). Lack of perceived sleep improvement after 4-month structured exercise programs. Menopause, 14(Pt 1), 535–540. Freedman, R. R., & Reohrs, T. A. (2005). Lack of sleep disturbance from menopausal hot flashes. Fertility and Sterility, 82(1), 138–145. Ghoncheh, S., & Smith, J. C. (2004). Progressive muscle relaxation, Yoga Stretching, and ABC relaxation theory. Journal of Clinical Psychology, 60(1), 131–136. Kaul, P., Passafiume, J., Sargent, R. C., & O'Hara, B. F. (2010). Meditation acutely improves psychomotor vigilance, and may decrease sleep need. Behavioral and Brain Functions, 6(47), 1–9, http://dx.doi.org/10.1186/1744-9081-6-47. Kwekkeboom, K. L., & Gretarsdottir, E. (2006). Systematic review of relaxation interventions for pain. Journal of Nursing Scholarship, 38(3), 269–277. Lynch, A. M., Jarvis, C. I., Debellis, R. J., & Morin, A. K. (2007). Nonpharmacologic approaches for the treatment of insomnia. American Journal of Lifestyle Medicine, 1(4), 274–282, http://dx.doi.org/10.1177/1559827607301. Manocha, R., Semmar, B., & Black, D. (2007). A pilot study of a mental silence from of meditation for women in perimenopause. Journal of Clinical Psychology in Medical Settings, 14, 266–273. Mansikkamäki, K., Raitanen, J., Nygård, C. H., Heinonen, R., Mikkola, T., Tomás, E., et al. (2012). Sleep quality and aerobic training among menopausal women—A randomized controlled trial. Maturitas, 72(4), 339–345, http://dx.doi.org/10.1016/j.maturitas.2012. 05.003 (Epub 2012 Jun 4).
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