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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05779371
Other study ID # FJU-IRB C106177
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2, 2019
Est. completion date July 31, 2021

Study information

Verified date March 2023
Source National Taipei University of Nursing and Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Laughter programs are safe, affordable, and age-appropriate activities. Few studies have utilized mixed study designs to look at the impact on resilience in and experiences of participants in such activities.


Description:

A high level of resilience can also help to mitigate the negative effects of stress and promote personal adaptation. According to a prior study, the resilience scale can be used to screen and identify maladaptive people before they cause problems, allowing for the development of preventive interventions (Wells, 2012). Some researchers have used cross talk and laughter therapy in patients with depression and reported that the negative symptoms of their mental health were alleviated (Yoshikawa et al., 2019), and laughter therapy for disabled adolescents improved their resilience (Shinde, & Kotekar, 2022). Another researcher discovered through interviews that older adults who laugh can maintain their personal health and age successfully (Lewis, 2021), but there is currently little research on how laughter affects the resilience of older adults. Previous research applied laughter as a mental health-promoting activity, called the Laughter Qigong program, to promote mental health and generate positive effects on both physical and mental well-being (Hsieh et al., 2015). According to Kuru Alc, Zorba Bahceli, and Emirolu (2018), laughter intervention is risk-free, inexpensive, and beneficial for promoting the mental health of older adults. It has been used successfully with these people in long-term care facilities (Hsieh et al, 2015). The IB-LQP was administered twice weekly for four weeks to older adults living in institutions. It was discovered to have a positive impact on stress cortisol levels (Hsieh et al., 2015), as well as the ability to lessen death fear and enhance loneliness (Kuru Alc, Zorba Bahceli, & Emirolu, 2018). The research on laughter-based interventions for community senior citizens is still in its early stages, and more research is needed to fully understand how senior citizens participate in locally tailored activities.


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date July 31, 2021
Est. primary completion date December 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: (1) age of ? 65 years, (2) ability to travel to the location of the activities on their own (independent or partially dependent people with daily activities), and (3) willingness to participate in this activity intervention Exclusion Criteria: (1) Severe hearing or sensory deficits that cause communication barriers, (2) diagnosis of depression, and (3) hospitalization plans in the next three months.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Integrated-based Laughing Qigong Program
The protocol of the Integrated-based Laughing Qigong Program (IB-LQP) combined laughter intervention and mental health promotion courses. It was a two-hour community activity held twice a week for six weeks. The content was 50-60 minutes of a laughter practice program and 50 minutes of mental health lectures, separated by a 10-minute break.

Locations

Country Name City State
Taiwan National Taipei University of Nursing and Health Sciences Taipei City

Sponsors (1)

Lead Sponsor Collaborator
National Taipei University of Nursing and Health Sciences

Country where clinical trial is conducted

Taiwan, 

References & Publications (20)

Ahern NR, Kiehl EM, Sole ML, Byers J. A review of instruments measuring resilience. Issues Compr Pediatr Nurs. 2006 Apr-Jun;29(2):103-25. doi: 10.1080/01460860600677643. — View Citation

Bahari, K., & Lorica, J. D. 2019. The effects of laughter therapy on mental health: An integrative literature review. The Malaysian Journal of Nursing (MJN), 10(3), 55-61. https://doi.org/10.31674/mjn.2019.v10i03.008

Bath PA, Deeg D. Social engagement and health outcomes among older people: introduction to a special section. Eur J Ageing. 2005 Mar;2(1):24-30. doi: 10.1007/s10433-005-0019-4. Epub 2005 Mar 9. No abstract available. — View Citation

Crane MF, Searle BJ, Kangas M, Nwiran Y. How resilience is strengthened by exposure to stressors: the systematic self-reflection model of resilience strengthening. Anxiety Stress Coping. 2019 Jan;32(1):1-17. doi: 10.1080/10615806.2018.1506640. Epub 2018 A — View Citation

Dyer JG, McGuinness TM. Resilience: analysis of the concept. Arch Psychiatr Nurs. 1996 Oct;10(5):276-82. doi: 10.1016/s0883-9417(96)80036-7. — View Citation

Ellis JM, Ben-Moshe R, Teshuva K. Laughter yoga activities for older people living in residential aged care homes: A feasibility study. Australas J Ageing. 2017 Sep;36(3):E28-E31. doi: 10.1111/ajag.12447. Epub 2017 Jul 12. — View Citation

Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146. — View Citation

Fetters MD, Curry LA, Creswell JW. Achieving integration in mixed methods designs-principles and practices. Health Serv Res. 2013 Dec;48(6 Pt 2):2134-56. doi: 10.1111/1475-6773.12117. Epub 2013 Oct 23. — View Citation

Fontes AP, Neri AL. Resilience in aging: literature review. Cien Saude Colet. 2015 May;20(5):1475-95. doi: 10.1590/1413-81232015205.00502014. English, Portuguese. — View Citation

Hsieh CJ, Chang C, Tsai G, Wu HF. Empirical study of the influence of a Laughing Qigong Program on long-term care residents. Geriatr Gerontol Int. 2015 Feb;15(2):165-73. doi: 10.1111/ggi.12244. Epub 2014 Feb 18. — View Citation

Ketefian S. Ethical considerations in research. Focus on vulnerable groups. Invest Educ Enferm. 2015;33(1):164-72. doi: 10.17533/udea.iee.v33n1a19. — View Citation

Kilpatrick LA, Siddarth P, Milillo MM, Krause-Sorio B, Ercoli L, Narr KL, Lavretsky H. Impact of Tai Chi as an adjunct treatment on brain connectivity in geriatric depression. J Affect Disord. 2022 Oct 15;315:1-6. doi: 10.1016/j.jad.2022.07.049. Epub 2022 — View Citation

Kirmayer LJ, Pedersen D. Toward a new architecture for global mental health. Transcult Psychiatry. 2014 Dec;51(6):759-76. doi: 10.1177/1363461514557202. Epub 2014 Oct 30. — View Citation

Kuiper, N.A. (2012). Theoretical Contributions Humor and Resiliency: Towards a Process Model of Coping and Growth. Europe's Journal of Psychology, 2012, Vol. 8(3), 475-491, doi:10.5964/ejop. v8i3.464

Kuru Alici N, Zorba Bahceli P, Emiroglu ON. The preliminary effects of laughter therapy on loneliness and death anxiety among older adults living in nursing homes: A nonrandomised pilot study. Int J Older People Nurs. 2018 Dec;13(4):e12206. doi: 10.1111/o — View Citation

Lewis, J. P. 2021. The role of laughter in the resilience and wellbeing of Alaska native elders. In The Routledge International Handbook of Indigenous Resilience (pp. 208-221). Routledge. DOI: 10.4324/9781003048428-18

Li SYH, Bressington D. The effects of mindfulness-based stress reduction on depression, anxiety, and stress in older adults: A systematic review and meta-analysis. Int J Ment Health Nurs. 2019 Jun;28(3):635-656. doi: 10.1111/inm.12568. Epub 2019 Jan 17. — View Citation

Lorish CD, Maisiak R. The Face Scale: a brief, nonverbal method for assessing patient mood. Arthritis Rheum. 1986 Jul;29(7):906-9. doi: 10.1002/art.1780290714. — View Citation

Madsen W, Ambrens M, Ohl M. Enhancing Resilience in Community-Dwelling Older Adults: A Rapid Review of the Evidence and Implications for Public Health Practitioners. Front Public Health. 2019 Feb 7;7:14. doi: 10.3389/fpubh.2019.00014. eCollection 2019. — View Citation

Mertens, D.M. and Hesse-Biber, S. (2012). Triangulation and Mixed Methods Research: Provocative Positions. Editorial. Journal of Mixed Methods Research 6(2) 75-79 DOI: 10.1177/1558689812437100

* Note: There are 20 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Chinese Version of the Resilience Scale The content of the Chinese version of the Resilience Scale includes five levels: a meaningful life, a peaceful mind, self-confidence, an indomitable spirit, and acceptance of the loneliness of existence. The highest score is 7 points (extremely satisfied), and the lowest score is 1 point (extremely dissatisfied). A higher score indicates greater resilience (Ahern, Kiehl, Sole, and Byers, 2006). Psychometric assessment of this scale has supported its internal consistency reliability and concurrent validity as good, and many studies have confirmed that the scale is applicable to samples of all ages and races (Ahern, Kiehl, Sole, Byers, 2006). The Cronbach's a for internal consistency in this study was .91. Pre-intervention(T0)
Primary The Face Scale The face scale is a nonverbal emotion scale used to evaluate students' participation in courses (Lorish and Maisiak, 1986). It has seven faces, with number one representing the happiest and number seven representing the saddest. Before and after taking the " IB-LQP " course, the participants chose the facial scale that best represented their mood. This scale is appropriate for assessing emotions after older adults participate in activities and has high reliability (Hsieh et al., 2015). Pre-intervention(T0)
Primary Chinese Version of the Resilience Scale The content of the Chinese version of the Resilience Scale includes five levels: a meaningful life, a peaceful mind, self-confidence, an indomitable spirit, and acceptance of the loneliness of existence. The highest score is 7 points (extremely satisfied), and the lowest score is 1 point (extremely dissatisfied). A higher score indicates greater resilience (Ahern, Kiehl, Sole, and Byers, 2006). Psychometric assessment of this scale has supported its internal consistency reliability and concurrent validity as good, and many studies have confirmed that the scale is applicable to samples of all ages and races (Ahern, Kiehl, Sole, Byers, 2006). The Cronbach's a for internal consistency in this study was .91 6-week after intervention (T1)
Primary The Face Scale The face scale is a nonverbal emotion scale used to evaluate students' participation in courses (Lorish and Maisiak, 1986). It has seven faces, with number one representing the happiest and number seven representing the saddest. Before and after taking the " IB-LQP " course, the participants chose the facial scale that best represented their mood. This scale is appropriate for assessing emotions after older adults participate in activities and has high reliability (Hsieh et al., 2015). 6-week after intervention (T1)
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