- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05779371
Effects of the Integrated-based Laughing Qigong Program on Resilience in Community-dwelling Older Adults
Effects of the Integrated-based Laughing Qigong Program on Resilience in Community-dwelling Older Adults: An Explanatory Sequential Mixed Method
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Taipei City, Taiwan, 112303
- National Taipei University of Nursing and Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Experimental group
Experiment group A accepted the Integrated-based Laughing Qigong Program (IB-LQP) During the intervention, the participants formed a standing circle and could make eye contact.
The time was divided into 10 minutes of warm-up (deep breathing, stretching of muscles, expressing various emotions on the face, stretching of limbs) and 30-40 minutes of main exercise (Breathing and Laughing Qigong practice).
The main exercise included using the natural breath of laughter to activate the body, turning a fake smile into a real smile and laughter, using different body movements at the same time, producing a variety of types of laughter, and conducting self-emotional awareness and emotional transformation drills to reduce the backlog.
|
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.
|
|
No Intervention: control group
The control group received no intervention and was asked to maintain their current lifestyle for 6 weeks following the baseline test.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Chinese Version of the Resilience Scale
Time Frame: Pre-intervention(T0)
|
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 α for internal consistency in this study was .91.
|
Pre-intervention(T0)
|
|
The Face Scale
Time Frame: Pre-intervention(T0)
|
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)
|
|
Chinese Version of the Resilience Scale
Time Frame: 6-week after intervention (T1)
|
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 α for internal consistency in this study was .91
|
6-week after intervention (T1)
|
|
The Face Scale
Time Frame: 6-week after intervention (T1)
|
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)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Chia Jung Hsieh, National Taipei University of Nursing and Health Sciences
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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
- 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 Aug 1.
- 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.
- 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.
- 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.
- 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.
- 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.
- Ketefian S. Ethical considerations in research. Focus on vulnerable groups. Invest Educ Enferm. 2015;33(1):164-72. doi: 10.17533/udea.iee.v33n1a19.
- 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 Jul 26.
- 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/opn.12206. Epub 2018 Jul 13.
- 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.
- 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
- 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.
- 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.
- 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.
- 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FJU-IRB C106177
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Community-dwelling Older Adults
-
National Taiwan University HospitalNot yet recruitingCommunity-dwelling Older Adults
-
Mélanie LevasseurCanadian Institutes of Health Research (CIHR)Active, not recruitingCommunity-dwelling Older AdultsCanada
-
University of ÉvoraHorizon 2020 - Portugal 2020 (ALT20-03-0145-FEDER-000007 - Project: ESACA); Departamento de Desporto e Saúde, Escola de Ciências e Tecnologia, Universidade de Évora, Évora, Portugal and other collaboratorsCompleted
-
Maastricht University Medical CenterCompletedCommunity-dwelling Older AdultsNetherlands
-
Cardenal Herrera UniversityCompleted
-
University of FloridaCompletedCommunity-dwelling Older AdultsUnited States
-
Maastricht University Medical CenterCompletedCommunity-dwelling Older AdultsNetherlands
-
National Taiwan University HospitalRecruitingCommunity-dwelling Older AdultsTaiwan
-
Bozyaka Training and Research HospitalCompletedCommunity-dwelling Older Adults
-
Riphah International UniversityCompletedCommunity Dwelling Older AdultsPakistan
Clinical Trials on Integrated-based Laughing Qigong Program
-
National Taipei University of Nursing and Health...National Science and Technology CouncilCompletedSchizophrenia | Medication Adherence | Medication ComplianceTaiwan
-
University of BarcelonaUniversity Ramon Llull; ICREA Academia; Institut de Neurociències de la Universitat... and other collaboratorsRecruiting
-
Eman Mohamed othmanNot yet recruiting
-
University of HoustonBrigham and Women's Hospital; Texas Woman's UniversityActive, not recruitingQuality of Life | Physical Function | Caregiver DistressUnited States
-
Tri-Service General HospitalCompleted
-
Akdeniz UniversityCompletedAnkylosing SpondylitisTurkey
-
The Hong Kong Polytechnic UniversityRecruitingCOVID-19 InfectionHong Kong
-
The Hong Kong Polytechnic UniversityHospital Authority, Hong KongCompleted
-
Artvin Coruh UniversityCompletedUnrecognized ConditionTurkey
-
Chonnam National University HospitalNot yet recruiting