THE JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE Volume 21, Number 4, 2015, pp. 217–222 ª Mary Ann Liebert, Inc. DOI: 10.1089/acm.2014.0152
Original Articles
The Effects of Laughter Therapy on Mood State and Self-Esteem in Cancer Patients Undergoing Radiation Therapy: A Randomized Controlled Trial So Hee Kim, RN, MSN, KOCN,1,* Jeong Ran Kook, RN, MSN,1,* Moonjung Kwon, RN,1 Myeong Ha Son, RN,1 Seung Do Ahn, MD, PhD,2 and Yeon Hee Kim, RN, PhD1
Abstract
Background: To investigate whether laughter therapy lowers total mood disturbance scores and improves selfesteem scores in patients with cancer. Design/Setting: Randomized controlled trial in a radio-oncology outpatient setting. Patients: Sixty-two patients were enrolled and randomly assigned to the experimental group (n = 33) or the wait list control group (n = 29). Interventions: Three laughter therapy sessions lasting 60 minutes each. Outcome measures: Mood state and self-esteem. Results: The intention-to-treat analysis revealed a significant main effect of group: Experimental group participants reported a 14.12-point reduction in total mood disturbance, while the wait list control group showed a 1.21-point reduction ( p = 0.001). The per-protocol analysis showed a significant main effect of group: The experimental group reported a 18.86-point decrease in total mood disturbance, while controls showed a 0.19point reduction ( p < 0.001). The self-esteem of experimental group was significantly greater than that of the wait list control group ( p = 0.044). Conclusions: These results indicate that laughter therapy can improve mood state and self-esteem and can be a beneficial, noninvasive intervention for patients with cancer in clinical settings.
Introduction
P
atients diagnosed with cancer in South Korea from 2006 to 2010 had a 5-year relative survival rate of 64.1%.1 Because the survival rate of patients with cancer has been on the rise, concerns regarding the mental health of these patients and their quality of life have also increased. Patients with cancer have a high level of psychological distress, and 20%-40% of this population is codiagnosed with depression and anxiety requiring therapeutic intervention.2–4 Psychological distress has a detrimental effect on patients’ overall state of health, self-management capabilities, length of hospitalization, and, ultimately, survival rate.3,5,6 In particular, patients with cancer who undergo radiation therapy exhibit significantly higher levels of psychological distress, especially indices of depression, such as negative
feelings, compared with the general Korean population.7,8 One consequence of this is that patients’ self-esteem is lowered, which is followed by an unwillingness to undergo treatment.9 For these reasons, the development of therapeutic interventions that may mitigate such psychological distress are necessary to improve the self-esteem of patients with cancer undergoing treatment.9 Typical radiation therapy requires patients to visit the hospital on weekdays for approximately 2–8 weeks.10–12 This overlap allows for both body and mind to be addressed together, providing for more holistic treatment. Recently, several studies have applied laughter therapy (LT) as a complementary intervention.13–18 To date, researchers have established that LT reduces a patient’s level of depression, anxiety, and stress; relieves physical pain; increases self-esteem and quality of life; and enhances the immune system.19–23
1
Department of Nursing, Asan Medical Center, Seoul, Korea. Department of Radiation Oncology, Asan Medical Center, Seoul, Korea. *These two authors contributed equally to this study.
2
217
218
Among the many studies of LT in clinical settings, only one appears to have illustrated the mood state effects of LT in patients with breast cancer in South Korea.13–16 No study has yet evaluated changes in mood and self-esteem after LT among patients with cancer in South Korea. The current study aimed to investigate the effect of LT on the mood and self-esteem of patients with cancer undergoing radiation therapy in order to establish a theoretical basis for its use during cancer treatment. Methods
This was a randomized, controlled, experimental study. Participants and ethical approval
The institutional review board at Asan Medical Center in Seoul, South Korea, approved this study (approval number: 2012-0736). The study was conducted at the radio-oncology outpatient clinic at the Asan Medical Center. The inclusion criteria for participants were the following: 20 years of age or older undergoing radiation therapy while receiving LT, scoring between 0 and 1 on The Eastern Cooperative Oncology Group scale,24 and possessing the ability to comprehend and answer the questionnaire. The following patients were excluded: those who were currently diagnosed with recurrent or metastatic cancer and those who had been exposed to other LTs before this study. And the patients who were diagnosed with psychiatric problems, including major depressive disorder and anxiety disorder, and were taking antipsychotic medication were also excluded, because it could affect the outcomes of this study (mood state and self-esteem). Patients who met the inclusion criteria were enrolled into the study after providing informed consent. They voluntarily agreed to participate; declared an understanding of the study purpose, methods, and potential adverse effects; and were informed of their right to withdraw at any time without penalty. They also received a leaflet with information on LT. Intervention
All intervention sessions were facilitated to by a staff nurse in the emergency department. Only one nurse ad-
FIG. 1. Recruitment and enrollment flowchart (n = 64). f/u, follow-up.
KIM ET AL.
ministered the experimental therapy in order to maintain the facilitating quality. She received LT certification upon completion of a 34-hour LT course at the Korea Laughter Clinic Academy. The LT intervention details were adapted to accommodate the LT program already being conducted at the time at the Asan Medical Center, which is open to all patients with cancer and their family members on a regular basis. However, the LT program in the Asan Medical Center was closed during the study period to avoid exposing the wait list control group to additional LT that was not study protocol directed. Participants in the experimental group received 60-minute LT sessions once per day over 3 consecutive days, with each participant receiving a total of three treatment sessions. Sessions began with a 10-minute introduction on the effect of laughter followed by 40 minutes of patient participation in physical activities directed to make them laugh aloud. These activities included laughing aloud for 15 seconds, moving the upper body from side to side to the beat of music, and clapping hands and stomping feet while smiling and saying ‘‘I love you’’ to the person beside them. The program ended with an opportunity for all participants to share their feelings, followed by meditation with quiet music. Participants in the wait list control group were provided with LT identical to that provided to the experimental group once they had completed the study. Data collection, sample size and randomization, and statistical methods
Demographic data and disease characteristics for all participants was obtained from their medical records. The level of mood state and self-esteem of both groups were each measured twice: 1 week before the application of LT and immediately after completion of the third LT session. The Korean version of the Profile of Mood States-Brief (POMS-B) was used to evaluate changes in mood states.25,26 The POMS-B consists of 30 questions, each using a 5-point Likert response scale.26 In addition to scoring total mood disturbance (TMD), the scale includes six subcategories: tension, depression, anger, vigor, fatigue, and confusion.26 Higher scores in each subcategory signify stronger mood states in the corresponding fields, whereas higher scores for TMD signify worsened mood states.26
EFFECTS OF LAUGHTER THERAPY
To measure self-esteem, the Rosenberg Self-Esteem Scale, developed by Rosenberg27 and adapted by Jeon,28 was used. It contains a total of 10 questions, 5 of which correspond to positive self-esteem and 5 to negative selfesteem. Responses to all items are rated on a 4-point Likert scale.27 Higher scores signify higher degrees of self-esteem and vice versa.27 The required sample size was calculated according to a procedure in a previous study that applied a psychological intervention on patients.29 The mean TMD scores for the experimental and wait list control groups were 17.7 and - 1.7, respectively, with a standard deviation estimated to be 24.29 A sample size of 31 patients per group was necessary to compare the mean TMD scores between the groups, given a dropout rate of 20%, with a two-sided independent t-test, using a 5% significance level and a power of 80% (G*Power, version 3.1.1; Heinrich-Heine-Universita¨t Du¨sseldorf, Du¨sseldorf, Germany). On a first-come, first-served basis, study participants were randomly assigned according to standard randomization procedures to the active LT experimental group or wait list control group by an investigator who had no clinical involvement in the study trials. Random numbers were stratified by sex, mixed in a 4 · 6 block, and generated online (http://www.randomization.com).30 Experimental group and wait list control group participants were distributed with a 1:1 ratio. Whereas participants allocated to the groups and data analysts were blinded to study assignment, the nurse who facilitated the LT program and the researchers were aware of the allocated group. Following the primary intention-to-treat (ITT) analysis, a secondary per-protocol (PP) analysis was conducted. Missing values were replaced by the last observation carried forward. The mean difference between the pretreatment and post-treatment values was measured in the two groups and analyzed with a Mann-Whitney test and independent t-test. General and disease characteristics were examined by the chi-square and Fisher exact test using SPSS software, version 18.0 (IBM, Armonk, NY). Results
A total of 436 patients were receiving radiation therapy between November 2012 and February 2013; 219 who did not meet the eligibility criteria were excluded. Two hundred and seventeen patients were invited to participate and received information about this study. Of these, 153 declined to participate because they were busy, were not interested in this subject, could not meet the schedule, or felt fatigued. Sixty-four patients agreed to participate in the study; 33 were randomly allocated to the experimental group and 31 to the wait list control group. Before the collection of baseline data, two patients dropped out of the study. Therefore, 62 participants were included in the ITT analysis. PP analysis was performed on 22 active LT experimental group members who participated in LT at least once and who completed the pre- and post-questionnaires. Eleven members from the experimental group were excluded from the PP analysis. While 2 members did participate in LT, their post-therapy results were not measured because the therapy was completed at the time of the postquestionnaire and they resided in the regional provinces.
219
Table 1. Baseline Characteristics of the Study Participants Characteristics (n = 62)
Experimental group (n = 33)
Control group (n = 29)
Age 30–49 12 (36.4) 9 (31.0) 50–69 19 (57.6) 13 (44.8) > 70 2 (6.1) 7 (24.1) Sex Male 10 (30.3) 10 (34.5) Female 23 (69.7) 19 (65.5) Marital status Married 28 (84.8) 26 (89.7) Unmarried 4 (12.1) 1 (3.4) Other 1 (3.0) 2 (6.9) Level of education Middle school 4 (12.1) 8 (27.6) High school 11 (33.3) 13 (44.8) College 18 (54.5) 8 (27.6) Religion No 7 (21.2) 8 (27.6) Yes 26 (78.8) 21 (72.4) Regular activity No 8 (24.2) 5 (17.2) Yes 25 (75.8) 24 (82.8) Economic burden None 14 (42.4) 5 (17.2) Mild 16 (48.5) 19 (65.5) Severe 3 (9.1) 5 (17.2) Cancer type Breast cancer 18 (54.5) 15 (51.7) Gastrointestinal cancer 6 (18.2) 5 (17.2) Other 9 (27.3) 9 (31.0) Past treatment None 2 (6.1) 5 (17.2) Surgery 20 (60.6) 11 (37.9) Chemotherapy 4 (12.1) 5 (17.2) Operation and 7 (21.2) 8 (27.6) chemotherapy Current co-treatment No 18 (54.5) 20 (69.0) Yes 15 (45.5) 9 (31.0) Time of radiotherapy (at the time of intervention) £ 2 wk 8 (24.2) 9 (31.0) 3–4 wk 16 (48.5) 15 (51.7) 5–6 wk 9 (27.3) 5 (17.2)
pValuea 0.166b
0.725 0.442b
0.078
0.559 0.499 0.098b
0.948
0.292b
0.245 0.613
Unless otherwise noted, values are the number (percentage) of participants. a p-Value was calculated with chi-square test. b p-Value was calculated with Fisher exact test.
Although the remaining 9 members answered the pre- and post-questionnaires, they were excluded because they did not participate in LT. Two could not participate because of schedule conflicts with their radiation treatments, 2 because of weak physical strength, and 1 because of concurrent illness with a cold. Moreover, 4 stated they did not participate because they felt the program was cumbersome. In the control group, 27 were included in the PP analysis and 1 was excluded because of exposure to LT before the
220
KIM ET AL.
Table 2. Scores for Mood State and Self-Esteem in the Experimental and Control Groups Before Laughter Therapy Variable Mood state Tension Depression Anger Vigor Fatigue Confusion Total mood disturbance Self-esteem
Experimental (n = 33)
Control (n = 29)
p-Valuea
6.52 – 3.72 5.15 – 4.49 5.70 – 4.13 7.39 – 4.11 5.15 – 3.67 6.30 – 3.18 21.42 – 20.28
6.86 – 3.97 5.69 – 3.65 5.83 – 3.60 6.28 – 3.75 6.31 – 4.34 6.62 – 2.68 25.03 – 17.99
0.724 0.609 0.895 0.270 0.259 0.674 0.464
20.73 – 4.74
19.10 – 4.43
0.171
Unless otherwise noted, values are the mean – standard deviation. a p-Value was calculated with independent t-test.
post-questionnaire. Another was excluded because of missing follow-up (Fig. 1). The mean participation rate was 1.7 sessions for the ITT analysis and 2.5 sessions for the PP analysis. Baseline demographic and clinical characteristics for the two groups did not differ at the 5% significance level (Tables 1 and 2). In the ITT analysis, the scores for tension, depression, and anger of the experimental LT group decreased by 2.30, 2.13, and 2.66 points, respectively, compared with the wait list control group ( p = 0.008, p = 0.023, p = 0.012) (Table 3). The experimental LT group scores for vigor increased by 3.55 points, whereas the wait list control group scores decreased by 0.38 points ( p < 0.001) (Table 3). The TMD scores decreased by 14.12 points in the experimental group and decreased by 1.21 points in the control group ( p = 0.001) (Table 3). The difference scores for fatigue, confusion, and self-esteem were not statistically significant between the pretest and post-test measurements for the two groups (Table 3). In the PP analysis, the scores for tension, depression, and anger in the experimental LT group decreased by 3.18, 2.84, and 3.68 points, respectively, reductions that were signifi-
cantly different from those in the wait list control group ( p = 0.001, p = 0.012, p = 0.003, respectively) (Table 3). The scores for vigor in the experimental LT group increased by 4.86 points, while those in the wait list control group decreased by 0.56 points ( p < 0.001) (Table 3). The reduction in TMD scores significantly differed between the experimental group (18.36 points) and wait list control group (0.19 points) ( p = 0.022) (Table 3). The fatigue score in the experimental LT group, which was not significantly different in the ITT analysis, showed a significant decline compared with the score in the wait list control group (Table 3). In addition, the self-esteem score in the experimental and wait list control groups significantly increased by 2.59 and 0.30, respectively ( p = 0.044) (Table 3). Both the ITT and PP results support the hypothesis that the LT group would have lower TMD scores than the wait list control group. However, only the PP analysis supported the hypothesis that the LT group would show an increase in self-esteem score. Discussion
This study investigated the effect of LT on the mood states and self-esteem of patients with cancer undergoing radiation therapy. The mood states of the patients in the experimental LT group improved significantly in four of the six subcategories used to characterize mood (tension, depression, anger, and vigor), as well as in the level of TMD. These results are consistent with numbers from a previous study, which documented changes in the mood states of patients with breast cancer after LT.15 However, the current findings are is not consistent with the results of previous studies that applied LT to patients undergoing hemodialysis. Kim and Lee reported that LT did not have a positive effect on depression.31 However, another study reported at the same time found LT to be effective for decreasing depression in another set of patients.32 This contradiction can be attributed to that fact that the former study used an ineffective intervention (simply showing participants a video) while the latter involved active participation of the patients in physical activities, consistent with the methods used in the present study. Moreover,
Table 3. Group Difference Scores for Mood State and Self-Esteem Between Pre- and Post-Laughter Therapy Intention-to-treat
Mood state Tension Depression Anger Vigor Fatigue Confusion Total mood disturbance Self-esteem
Per-Protocol
Experimental (n = 33)
Control (n = 29)
p-Valuea
Experimental (n = 22)
Control (n = 27)
p-Valuea
- 2.82 – 3.26 - 2.30 – 3.84 - 2.52 – 2.97 3.55 – 4.90 - 1.67 – 3.84 - 1.27 – 3.00 - 14.12 – 17.70 1.697 – 3.87
- 0.52 – 3.88 - 0.17 – 3.52 0.14 – 4.67 - 0.38 – 2.80 - 0.76 – 3.25 - 0.28 – 2.56 - 1.21 – 15.11 0.241 – 2.96
0.008 0.023 0.012 < 0.001 0.135 0.271 0.001 0.148
- 3.55 – 3.32 - 2.95 – 4.39 - 3.27 – 3.21 4.86 – 4.89 - 2.55 – 3.89 - 1.68 – 3.21 - 18.86 – 17.95 2.59 – 4.15
- 0.37 – 3.92 - 0.11 – 3.63 0.41 – 4.63 - 0.56 – 2.76 - 0.52 – 3.04 - 0.15 – 2.55 - 0.19 – 14.59 0.30 – 3.06
0.001 0.012 0.003 < 0.001 0.026 0.145 < 0.001 0.044
Unless otherwise noted, values are the mean – standard deviation. a p-Value was calculated with Mann-Whitney test.
EFFECTS OF LAUGHTER THERAPY
because the patients shared their feelings after LT with each other (allowing them to feel group cohesiveness with fellow cancer patients), that process may affect the results.33 The ITT analysis did not reveal an effect of LT on selfesteem but the PP analysis showed a positive effect, which coincides with the results of previous studies.21,33,34 In the current study, although LT also showed positive effects on fatigue, only in PP analysis was this effect significant. Because few studies have addressed the effect of LT on fatigue in patients with cancer, it is premature to compare those results with those presented herein. However, it can be postulated that LT may be effective for reducing fatigue because physical exercise has been shown to be effective in decreasing fatigue. Furthermore, the decreased indices of depression following LT may contribute to decreasing fatigue.35 According to the study results, it is considered necessary that LT be structured to include active participation of patients in physical activities and opportunities to laugh aloud instead of just smiling. In a previous study, the number of LT sessions and the duration of these sessions varied.13,15,16 Studies that delivered LT in eight 20-minute sessions or a single 60-minute session all showed improved mood states following LT.13,15,16 Similarly, an LT study by Kim et al. documented decreased anxiety, depression, and stress for female patients with cancer after use of 60-minute sessions (average session participation rate, 2.7 sessions).16 In the current study, patients attended an average of 1.7 sessions in the ITT analysis and 2.5 in the PP analysis. For both analysis groups, positive effects were observed in tension, depression, anger, vigor, and TMD, while fatigue and self-esteem were positively affected only in the PP analysis. It could be assumed that a higher frequency of participation would result in more beneficial effects. As such, despite the positive effects after only one session in previous studies, the current PP analysis revealed that patients should participate in at least three sessions of LT to accrue adequate positive effects. The study had some limitations. It was a small investigation conducted in a single country. The study period was limited to the time during which patients received radiation therapy; thus, the long-term effects of LT were not assessed. Thus, future studies should investigate repeated testing and the long-term effects of LT. In conclusion, this study found that LT has a positive effect on improving mood states and self-esteem. Therefore, LT should be considered as a noninvasive complementary intervention to improve the mood states of patients with cancer in clinical nursing practice. Author Disclosure Statement
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3. 4. 5.
6. 7. 8. 9. 10.
11. 12. 13. 14. 15. 16.
17. 18. 19. 20.
No competing financial relationships exist. References
1. Jung KW, Won YJ, Kong HJ, Oh CM, Seo HG, Lee J-S. Cancer statistics in Korea: incidence, mortality, survival and prevalence in 2010. Cancer Res Treat 2013;45:1–14. 2. Luckett T, Butow PN, King MT, et al. A review and recommendations for optimal outcome measures of anxiety, depression and general distress in studies evaluating psychosocial interventions for English-speaking adults with
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heterogeneous cancer diagnoses. Support Care Cancer 2010;18:1241–1262. Massie MJ. Prevalence of depression in patients with cancer. J Natl Cancer Inst Monographs 2004;2004:57–71. Ohnishi H. Mental distress in cancer patients. Masui. Jpn J Anesthesiol 2011;60:1024–1031. Burgess C, Cornelius V, Love S, Graham J, Richards M, Ramirez A. Depression and anxiety in women with early breast cancer: five year observational cohort study. BMJ 2005;330:702. Katon WJ. Clinical and health services relationships between major depression, depressive symptoms, and general medical illness. Biol Psychiatry 2003;54:216–226. Yang JC, Chung WK. Psychology and quality of life in cancer patients on radiation therapy. J Korean Soc Therap Radiol Oncol 2004;22:271–279. Ko E, So HS. Fatigue and mood state among cancer patients receiving radiation therapy. Chonnam J Nurs Sci 2004;9:89–103. Jeong CY, Yang JC, Shin IS, et al. Psychopathology, self esteem and quality of life in cancer patients with radiotherapy. Korean J Psychosom Med 2002;10:92–100. Delaney G, Jacob S, Featherstone C, Barton M. The role of radiotherapy in cancer treatment: estimating optimal utilization from a review of evidence-based clinical guidelines. Cancer 2005;104:1129–1137. Stiegelis HE, Ranchor AV, Sanderman R. Psychological functioning in cancer patients treated with radiotherapy. Patient Educ Counsel 2004;52:131–141. Hahn CA, Dunn R, Halperin EC. Routine screening for depression in radiation oncology patients. Am J Clin Oncol 2004;27:497–499. Han HJ, Park A, Kim HS, Moon H, Park Y-H. The effects of laughter therapy on stress responses in patients with preoperative breast cancer. J Korean Oncol Nur 2011;11:93–100. Cho EA, Oh HE. Effects of laughter therapy on depression, quality of life, resilience and immune responses in breast cancer survivors. J Korean Acad Nurs 2011;41:285–293. Choi J, Kim K, Cha S, Pyo H, Kim Y. Effects of laughter therapy on mood, pain, and stress of mastectomy patients. J Korean Clin Nurs Res 2010;16:83–93. Kim SH, Kim YH, Kim HJ, Lee SH, Yu SO. The effect of laughter therapy on depression, anxiety, and stress in patients with breast cancer undergoing radiotherapy. J Korean Oncol Nurs 2009;9:155–162. Bennett MP, Zeller JM, Rosenberg L, McCann J. The effect of mirthful laughter on stress and natural killer cell activity. Alternat Ther Health Med 2003;9:38–45. Christie W, Moore C. The impact of humor on patients with cancer. Clin J Oncol Nurs 2005;9:211–218. Kim J, Lee E. A study on the effectiveness of a laughter therapy program for the mental health of the elderly. Korean Assoc Family Welfare 2012;17:85–104. Shahidi M, Mojtahed A, Modabbernia A, et al. Laughter yoga versus group exercise program in elderly depressed women: a randomized controlled trial. Int J Geriatr Psychiatry 2011;26:322–327. Kim S, Sun H. The effectiveness of a laughter therapy group counseling program for anxiety, depression, and low selfesteem in mothers. Korean J Child Studies 2010;31:197–207. Walter M, Hanni B, Haug M, et al. Humour therapy in patients with late-life depression or Alzheimer’s disease: a pilot study. Int J Geriatr Psychiatry 2007;22:77–83. Lee J. The laughter therapy for hospice patients. Korean J Hospice Palliat Care 2003;6:228–230.
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24. Sorensen JB, Klee M, Palshof T, Hansen HH. Performance status assessment in cancer patients. An inter-observer variability study. Br J Cancer 1993;67:773–775. 25. Yeun EJ, Shin-Park KK. Verification of the profile of mood states-brief: cross-cultural analysis. J Clin Psychol 2006;62: 1173–1180. 26. Terry PC, Lane AM, Fogarty GJ. Construct validity of the Profile of Mood States—Adolescents for use with adults. Psychol Sport Exercise 2003;4:125–139. 27. Rosenberg M. Society and the Adolescent Self-Image. Middletown, CT: Wesleyan University Press, 1989. 28. Jeon BJ. Self-esteem: a test of its measurability. Yonsei Nonchong 1974;11:109–129. 29. Wichrowski M, Whiteson J, Haas F, Mola A, Rey MJ. Effects of horticultural therapy on mood and heart rate in patients participating in an inpatient cardiopulmonary rehabilitation program. J Cardiopulmon Rehab 2005;25: 270–274. 30. Randomization.com [homepage on Internet]. Online document at http://www.randomization.com. Accessed January 23, 2014. 31. Kim KH, Lee MH. Effects of humor intervention program on anxiety, depression and coping of humor in
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hemodialysis patients. Korean J Rehab Nurs 1999;2: 95–108. Lee KI, Eun Y. Effect of laughter therapy on pain, depression and sleep with elderly patients in long term care facility. J Muscle Joint Health 2011;18:28–38. Yalom I, Leszcz M. The Theory and Practice of Group Psychotherapy (5th ed.). Translated by Choi HR, Jang SS. Seoul, Korea: HANA, 2008. Hassed C. How humour keeps you well. Austral Fam Physician 2001;30:25–28. Oh PJ, Jung JA. A meta-analysis of intervention studies on cancer-related fatigue in Korea: 1990–2010. J Korean Clin Nurs Res 2011;17:163–175.
Address correspondence to: Yeon Hee Kim, RN, PhD Department of Nursing Asan Medical Center 43-gil Olympic-ro, Songpa-gu Seoul 138-736 Korea E-mail: [email protected]
Original Articles
The Effects of Laughter Therapy on Mood State and Self-Esteem in Cancer Patients Undergoing Radiation Therapy: A Randomized Controlled Trial So Hee Kim, RN, MSN, KOCN,1,* Jeong Ran Kook, RN, MSN,1,* Moonjung Kwon, RN,1 Myeong Ha Son, RN,1 Seung Do Ahn, MD, PhD,2 and Yeon Hee Kim, RN, PhD1
Abstract
Background: To investigate whether laughter therapy lowers total mood disturbance scores and improves selfesteem scores in patients with cancer. Design/Setting: Randomized controlled trial in a radio-oncology outpatient setting. Patients: Sixty-two patients were enrolled and randomly assigned to the experimental group (n = 33) or the wait list control group (n = 29). Interventions: Three laughter therapy sessions lasting 60 minutes each. Outcome measures: Mood state and self-esteem. Results: The intention-to-treat analysis revealed a significant main effect of group: Experimental group participants reported a 14.12-point reduction in total mood disturbance, while the wait list control group showed a 1.21-point reduction ( p = 0.001). The per-protocol analysis showed a significant main effect of group: The experimental group reported a 18.86-point decrease in total mood disturbance, while controls showed a 0.19point reduction ( p < 0.001). The self-esteem of experimental group was significantly greater than that of the wait list control group ( p = 0.044). Conclusions: These results indicate that laughter therapy can improve mood state and self-esteem and can be a beneficial, noninvasive intervention for patients with cancer in clinical settings.
Introduction
P
atients diagnosed with cancer in South Korea from 2006 to 2010 had a 5-year relative survival rate of 64.1%.1 Because the survival rate of patients with cancer has been on the rise, concerns regarding the mental health of these patients and their quality of life have also increased. Patients with cancer have a high level of psychological distress, and 20%-40% of this population is codiagnosed with depression and anxiety requiring therapeutic intervention.2–4 Psychological distress has a detrimental effect on patients’ overall state of health, self-management capabilities, length of hospitalization, and, ultimately, survival rate.3,5,6 In particular, patients with cancer who undergo radiation therapy exhibit significantly higher levels of psychological distress, especially indices of depression, such as negative
feelings, compared with the general Korean population.7,8 One consequence of this is that patients’ self-esteem is lowered, which is followed by an unwillingness to undergo treatment.9 For these reasons, the development of therapeutic interventions that may mitigate such psychological distress are necessary to improve the self-esteem of patients with cancer undergoing treatment.9 Typical radiation therapy requires patients to visit the hospital on weekdays for approximately 2–8 weeks.10–12 This overlap allows for both body and mind to be addressed together, providing for more holistic treatment. Recently, several studies have applied laughter therapy (LT) as a complementary intervention.13–18 To date, researchers have established that LT reduces a patient’s level of depression, anxiety, and stress; relieves physical pain; increases self-esteem and quality of life; and enhances the immune system.19–23
1
Department of Nursing, Asan Medical Center, Seoul, Korea. Department of Radiation Oncology, Asan Medical Center, Seoul, Korea. *These two authors contributed equally to this study.
2
217
218
Among the many studies of LT in clinical settings, only one appears to have illustrated the mood state effects of LT in patients with breast cancer in South Korea.13–16 No study has yet evaluated changes in mood and self-esteem after LT among patients with cancer in South Korea. The current study aimed to investigate the effect of LT on the mood and self-esteem of patients with cancer undergoing radiation therapy in order to establish a theoretical basis for its use during cancer treatment. Methods
This was a randomized, controlled, experimental study. Participants and ethical approval
The institutional review board at Asan Medical Center in Seoul, South Korea, approved this study (approval number: 2012-0736). The study was conducted at the radio-oncology outpatient clinic at the Asan Medical Center. The inclusion criteria for participants were the following: 20 years of age or older undergoing radiation therapy while receiving LT, scoring between 0 and 1 on The Eastern Cooperative Oncology Group scale,24 and possessing the ability to comprehend and answer the questionnaire. The following patients were excluded: those who were currently diagnosed with recurrent or metastatic cancer and those who had been exposed to other LTs before this study. And the patients who were diagnosed with psychiatric problems, including major depressive disorder and anxiety disorder, and were taking antipsychotic medication were also excluded, because it could affect the outcomes of this study (mood state and self-esteem). Patients who met the inclusion criteria were enrolled into the study after providing informed consent. They voluntarily agreed to participate; declared an understanding of the study purpose, methods, and potential adverse effects; and were informed of their right to withdraw at any time without penalty. They also received a leaflet with information on LT. Intervention
All intervention sessions were facilitated to by a staff nurse in the emergency department. Only one nurse ad-
FIG. 1. Recruitment and enrollment flowchart (n = 64). f/u, follow-up.
KIM ET AL.
ministered the experimental therapy in order to maintain the facilitating quality. She received LT certification upon completion of a 34-hour LT course at the Korea Laughter Clinic Academy. The LT intervention details were adapted to accommodate the LT program already being conducted at the time at the Asan Medical Center, which is open to all patients with cancer and their family members on a regular basis. However, the LT program in the Asan Medical Center was closed during the study period to avoid exposing the wait list control group to additional LT that was not study protocol directed. Participants in the experimental group received 60-minute LT sessions once per day over 3 consecutive days, with each participant receiving a total of three treatment sessions. Sessions began with a 10-minute introduction on the effect of laughter followed by 40 minutes of patient participation in physical activities directed to make them laugh aloud. These activities included laughing aloud for 15 seconds, moving the upper body from side to side to the beat of music, and clapping hands and stomping feet while smiling and saying ‘‘I love you’’ to the person beside them. The program ended with an opportunity for all participants to share their feelings, followed by meditation with quiet music. Participants in the wait list control group were provided with LT identical to that provided to the experimental group once they had completed the study. Data collection, sample size and randomization, and statistical methods
Demographic data and disease characteristics for all participants was obtained from their medical records. The level of mood state and self-esteem of both groups were each measured twice: 1 week before the application of LT and immediately after completion of the third LT session. The Korean version of the Profile of Mood States-Brief (POMS-B) was used to evaluate changes in mood states.25,26 The POMS-B consists of 30 questions, each using a 5-point Likert response scale.26 In addition to scoring total mood disturbance (TMD), the scale includes six subcategories: tension, depression, anger, vigor, fatigue, and confusion.26 Higher scores in each subcategory signify stronger mood states in the corresponding fields, whereas higher scores for TMD signify worsened mood states.26
EFFECTS OF LAUGHTER THERAPY
To measure self-esteem, the Rosenberg Self-Esteem Scale, developed by Rosenberg27 and adapted by Jeon,28 was used. It contains a total of 10 questions, 5 of which correspond to positive self-esteem and 5 to negative selfesteem. Responses to all items are rated on a 4-point Likert scale.27 Higher scores signify higher degrees of self-esteem and vice versa.27 The required sample size was calculated according to a procedure in a previous study that applied a psychological intervention on patients.29 The mean TMD scores for the experimental and wait list control groups were 17.7 and - 1.7, respectively, with a standard deviation estimated to be 24.29 A sample size of 31 patients per group was necessary to compare the mean TMD scores between the groups, given a dropout rate of 20%, with a two-sided independent t-test, using a 5% significance level and a power of 80% (G*Power, version 3.1.1; Heinrich-Heine-Universita¨t Du¨sseldorf, Du¨sseldorf, Germany). On a first-come, first-served basis, study participants were randomly assigned according to standard randomization procedures to the active LT experimental group or wait list control group by an investigator who had no clinical involvement in the study trials. Random numbers were stratified by sex, mixed in a 4 · 6 block, and generated online (http://www.randomization.com).30 Experimental group and wait list control group participants were distributed with a 1:1 ratio. Whereas participants allocated to the groups and data analysts were blinded to study assignment, the nurse who facilitated the LT program and the researchers were aware of the allocated group. Following the primary intention-to-treat (ITT) analysis, a secondary per-protocol (PP) analysis was conducted. Missing values were replaced by the last observation carried forward. The mean difference between the pretreatment and post-treatment values was measured in the two groups and analyzed with a Mann-Whitney test and independent t-test. General and disease characteristics were examined by the chi-square and Fisher exact test using SPSS software, version 18.0 (IBM, Armonk, NY). Results
A total of 436 patients were receiving radiation therapy between November 2012 and February 2013; 219 who did not meet the eligibility criteria were excluded. Two hundred and seventeen patients were invited to participate and received information about this study. Of these, 153 declined to participate because they were busy, were not interested in this subject, could not meet the schedule, or felt fatigued. Sixty-four patients agreed to participate in the study; 33 were randomly allocated to the experimental group and 31 to the wait list control group. Before the collection of baseline data, two patients dropped out of the study. Therefore, 62 participants were included in the ITT analysis. PP analysis was performed on 22 active LT experimental group members who participated in LT at least once and who completed the pre- and post-questionnaires. Eleven members from the experimental group were excluded from the PP analysis. While 2 members did participate in LT, their post-therapy results were not measured because the therapy was completed at the time of the postquestionnaire and they resided in the regional provinces.
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Table 1. Baseline Characteristics of the Study Participants Characteristics (n = 62)
Experimental group (n = 33)
Control group (n = 29)
Age 30–49 12 (36.4) 9 (31.0) 50–69 19 (57.6) 13 (44.8) > 70 2 (6.1) 7 (24.1) Sex Male 10 (30.3) 10 (34.5) Female 23 (69.7) 19 (65.5) Marital status Married 28 (84.8) 26 (89.7) Unmarried 4 (12.1) 1 (3.4) Other 1 (3.0) 2 (6.9) Level of education Middle school 4 (12.1) 8 (27.6) High school 11 (33.3) 13 (44.8) College 18 (54.5) 8 (27.6) Religion No 7 (21.2) 8 (27.6) Yes 26 (78.8) 21 (72.4) Regular activity No 8 (24.2) 5 (17.2) Yes 25 (75.8) 24 (82.8) Economic burden None 14 (42.4) 5 (17.2) Mild 16 (48.5) 19 (65.5) Severe 3 (9.1) 5 (17.2) Cancer type Breast cancer 18 (54.5) 15 (51.7) Gastrointestinal cancer 6 (18.2) 5 (17.2) Other 9 (27.3) 9 (31.0) Past treatment None 2 (6.1) 5 (17.2) Surgery 20 (60.6) 11 (37.9) Chemotherapy 4 (12.1) 5 (17.2) Operation and 7 (21.2) 8 (27.6) chemotherapy Current co-treatment No 18 (54.5) 20 (69.0) Yes 15 (45.5) 9 (31.0) Time of radiotherapy (at the time of intervention) £ 2 wk 8 (24.2) 9 (31.0) 3–4 wk 16 (48.5) 15 (51.7) 5–6 wk 9 (27.3) 5 (17.2)
pValuea 0.166b
0.725 0.442b
0.078
0.559 0.499 0.098b
0.948
0.292b
0.245 0.613
Unless otherwise noted, values are the number (percentage) of participants. a p-Value was calculated with chi-square test. b p-Value was calculated with Fisher exact test.
Although the remaining 9 members answered the pre- and post-questionnaires, they were excluded because they did not participate in LT. Two could not participate because of schedule conflicts with their radiation treatments, 2 because of weak physical strength, and 1 because of concurrent illness with a cold. Moreover, 4 stated they did not participate because they felt the program was cumbersome. In the control group, 27 were included in the PP analysis and 1 was excluded because of exposure to LT before the
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KIM ET AL.
Table 2. Scores for Mood State and Self-Esteem in the Experimental and Control Groups Before Laughter Therapy Variable Mood state Tension Depression Anger Vigor Fatigue Confusion Total mood disturbance Self-esteem
Experimental (n = 33)
Control (n = 29)
p-Valuea
6.52 – 3.72 5.15 – 4.49 5.70 – 4.13 7.39 – 4.11 5.15 – 3.67 6.30 – 3.18 21.42 – 20.28
6.86 – 3.97 5.69 – 3.65 5.83 – 3.60 6.28 – 3.75 6.31 – 4.34 6.62 – 2.68 25.03 – 17.99
0.724 0.609 0.895 0.270 0.259 0.674 0.464
20.73 – 4.74
19.10 – 4.43
0.171
Unless otherwise noted, values are the mean – standard deviation. a p-Value was calculated with independent t-test.
post-questionnaire. Another was excluded because of missing follow-up (Fig. 1). The mean participation rate was 1.7 sessions for the ITT analysis and 2.5 sessions for the PP analysis. Baseline demographic and clinical characteristics for the two groups did not differ at the 5% significance level (Tables 1 and 2). In the ITT analysis, the scores for tension, depression, and anger of the experimental LT group decreased by 2.30, 2.13, and 2.66 points, respectively, compared with the wait list control group ( p = 0.008, p = 0.023, p = 0.012) (Table 3). The experimental LT group scores for vigor increased by 3.55 points, whereas the wait list control group scores decreased by 0.38 points ( p < 0.001) (Table 3). The TMD scores decreased by 14.12 points in the experimental group and decreased by 1.21 points in the control group ( p = 0.001) (Table 3). The difference scores for fatigue, confusion, and self-esteem were not statistically significant between the pretest and post-test measurements for the two groups (Table 3). In the PP analysis, the scores for tension, depression, and anger in the experimental LT group decreased by 3.18, 2.84, and 3.68 points, respectively, reductions that were signifi-
cantly different from those in the wait list control group ( p = 0.001, p = 0.012, p = 0.003, respectively) (Table 3). The scores for vigor in the experimental LT group increased by 4.86 points, while those in the wait list control group decreased by 0.56 points ( p < 0.001) (Table 3). The reduction in TMD scores significantly differed between the experimental group (18.36 points) and wait list control group (0.19 points) ( p = 0.022) (Table 3). The fatigue score in the experimental LT group, which was not significantly different in the ITT analysis, showed a significant decline compared with the score in the wait list control group (Table 3). In addition, the self-esteem score in the experimental and wait list control groups significantly increased by 2.59 and 0.30, respectively ( p = 0.044) (Table 3). Both the ITT and PP results support the hypothesis that the LT group would have lower TMD scores than the wait list control group. However, only the PP analysis supported the hypothesis that the LT group would show an increase in self-esteem score. Discussion
This study investigated the effect of LT on the mood states and self-esteem of patients with cancer undergoing radiation therapy. The mood states of the patients in the experimental LT group improved significantly in four of the six subcategories used to characterize mood (tension, depression, anger, and vigor), as well as in the level of TMD. These results are consistent with numbers from a previous study, which documented changes in the mood states of patients with breast cancer after LT.15 However, the current findings are is not consistent with the results of previous studies that applied LT to patients undergoing hemodialysis. Kim and Lee reported that LT did not have a positive effect on depression.31 However, another study reported at the same time found LT to be effective for decreasing depression in another set of patients.32 This contradiction can be attributed to that fact that the former study used an ineffective intervention (simply showing participants a video) while the latter involved active participation of the patients in physical activities, consistent with the methods used in the present study. Moreover,
Table 3. Group Difference Scores for Mood State and Self-Esteem Between Pre- and Post-Laughter Therapy Intention-to-treat
Mood state Tension Depression Anger Vigor Fatigue Confusion Total mood disturbance Self-esteem
Per-Protocol
Experimental (n = 33)
Control (n = 29)
p-Valuea
Experimental (n = 22)
Control (n = 27)
p-Valuea
- 2.82 – 3.26 - 2.30 – 3.84 - 2.52 – 2.97 3.55 – 4.90 - 1.67 – 3.84 - 1.27 – 3.00 - 14.12 – 17.70 1.697 – 3.87
- 0.52 – 3.88 - 0.17 – 3.52 0.14 – 4.67 - 0.38 – 2.80 - 0.76 – 3.25 - 0.28 – 2.56 - 1.21 – 15.11 0.241 – 2.96
0.008 0.023 0.012 < 0.001 0.135 0.271 0.001 0.148
- 3.55 – 3.32 - 2.95 – 4.39 - 3.27 – 3.21 4.86 – 4.89 - 2.55 – 3.89 - 1.68 – 3.21 - 18.86 – 17.95 2.59 – 4.15
- 0.37 – 3.92 - 0.11 – 3.63 0.41 – 4.63 - 0.56 – 2.76 - 0.52 – 3.04 - 0.15 – 2.55 - 0.19 – 14.59 0.30 – 3.06
0.001 0.012 0.003 < 0.001 0.026 0.145 < 0.001 0.044
Unless otherwise noted, values are the mean – standard deviation. a p-Value was calculated with Mann-Whitney test.
EFFECTS OF LAUGHTER THERAPY
because the patients shared their feelings after LT with each other (allowing them to feel group cohesiveness with fellow cancer patients), that process may affect the results.33 The ITT analysis did not reveal an effect of LT on selfesteem but the PP analysis showed a positive effect, which coincides with the results of previous studies.21,33,34 In the current study, although LT also showed positive effects on fatigue, only in PP analysis was this effect significant. Because few studies have addressed the effect of LT on fatigue in patients with cancer, it is premature to compare those results with those presented herein. However, it can be postulated that LT may be effective for reducing fatigue because physical exercise has been shown to be effective in decreasing fatigue. Furthermore, the decreased indices of depression following LT may contribute to decreasing fatigue.35 According to the study results, it is considered necessary that LT be structured to include active participation of patients in physical activities and opportunities to laugh aloud instead of just smiling. In a previous study, the number of LT sessions and the duration of these sessions varied.13,15,16 Studies that delivered LT in eight 20-minute sessions or a single 60-minute session all showed improved mood states following LT.13,15,16 Similarly, an LT study by Kim et al. documented decreased anxiety, depression, and stress for female patients with cancer after use of 60-minute sessions (average session participation rate, 2.7 sessions).16 In the current study, patients attended an average of 1.7 sessions in the ITT analysis and 2.5 in the PP analysis. For both analysis groups, positive effects were observed in tension, depression, anger, vigor, and TMD, while fatigue and self-esteem were positively affected only in the PP analysis. It could be assumed that a higher frequency of participation would result in more beneficial effects. As such, despite the positive effects after only one session in previous studies, the current PP analysis revealed that patients should participate in at least three sessions of LT to accrue adequate positive effects. The study had some limitations. It was a small investigation conducted in a single country. The study period was limited to the time during which patients received radiation therapy; thus, the long-term effects of LT were not assessed. Thus, future studies should investigate repeated testing and the long-term effects of LT. In conclusion, this study found that LT has a positive effect on improving mood states and self-esteem. Therefore, LT should be considered as a noninvasive complementary intervention to improve the mood states of patients with cancer in clinical nursing practice. Author Disclosure Statement
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3. 4. 5.
6. 7. 8. 9. 10.
11. 12. 13. 14. 15. 16.
17. 18. 19. 20.
No competing financial relationships exist. References
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Address correspondence to: Yeon Hee Kim, RN, PhD Department of Nursing Asan Medical Center 43-gil Olympic-ro, Songpa-gu Seoul 138-736 Korea E-mail: [email protected]
