Effects of a Laughter Yoga Program in Adolescents With Disabilities
Preliminarily Effects of a Laughter Yoga Program on the Mood, Anxiety, and Loneliness Among Adolescents With Intellectual and Physical Disabilities in a Special School: a Pilot Randomized Controlled Trial
1 other identifier
interventional
45
1 country
1
Brief Summary
A pilot randomized controlled trial will be adopted. A total of forty adolescents with intellectual and physical disabilities will be randomly allocated into either intervention group receiving a 4-week laughter yoga programme (8 sessions) or control group receiving routine care in a 1:1 ratio based on computer-generated random schedule. The aim of this pilot study is to preliminarily evaluate the effects of a 4-week laughter yoga programme (8 sessions) on the mood, anxiety and loneliness among adolescents with intellectual and physical disabilities in a special school in Hong Kong. Hypotheses for primary outcomes of this study are as follows: H.1 Participants receiving the 4-week laughter yoga programme (8 sessions) (intervention group) will have a greater improvement on mood level than the participants receiving routine care provided by the special school as usual (control group). H.2 Participants receiving the 4-week laughter yoga programme (8 sessions) (intervention group) will have a greater reduction on anxiety than the participants receiving routine care provided by the special school as usual (control group). H.3 Participants receiving the 4-week laughter yoga programme (8 sessions) (intervention group) will have a greater reduction on loneliness than the participants receiving routine care provided by the special school as usual (control group).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 27, 2023
CompletedFirst Submitted
Initial submission to the registry
February 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 26, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 26, 2023
CompletedFirst Posted
Study publicly available on registry
April 27, 2023
CompletedMarch 30, 2026
March 1, 2026
2 months
February 6, 2023
March 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Mood
The Mood Scale includes five different emoji with a 5-points response scale of mood ranging from 1-5: 1-Very bad; 2-bad, 3-so-so, 4-good; to 5-very good. The range of scale score can be from 1 to 5 where higher scores represented very good mood and emotion using emoji.
Before the intervention
Mood
The Mood Scale includes five different emoji with a 5-points response scale of mood ranging from 1-5: 1-Very bad; 2-bad, 3-so-so, 4-good; to 5-very good. The range of scale score can be from 1 to 5 where higher scores represented very good mood and emotion using emoji.
Immediate after the intervention
Anxiety
The STAI-6 contains 6 items which is sensitive to fluctuations in state anxiety. Observers will be asked to answer each item using the following scale (Scale of 1-5; 1 = not at all / very slightly, 2 = a little, 3 = moderately, 4 = quite a bit, 5 = extremely). The range of score from 6 to 24. The highest score shows a high anxiety level of individual. Back translation of the STAI-6 had been performed after obtained the content validity index (CVI=1.0).
Before the intervention
Anxiety
The STAI-6 contains 6 items which is sensitive to fluctuations in state anxiety. Observers will be asked to answer each item using the following scale (Scale of 1-5; 1 = not at all / very slightly, 2 = a little, 3 = moderately, 4 = quite a bit, 5 = extremely). The range of score from 6 to 24. The highest score shows a high anxiety level of individual. Back translation of the STAI-6 had been performed after obtained the content validity index (CVI=1.0).
Immediate after the intervention
Loneliness
The UCLA Loneliness Scale (ULS-8) contains 8 items including two factors: intimate other and social other. There are six items in the intimate factor and two items in the social other factor. Observers are asked to answer each item using the following scale: 1=Never, 2=Rarely, 3=Sometimes, 4=Often. It is a 4-point Likert scale with values from "never" to "always". For each participant, responses on the 4-items were totaled to create a composite loneliness score, with higher scores indicated higher loneliness. Scores ranged from 8 to 32. The 8-item measure demonstrated high internal reliability (α=0.84).
Before the intervention
Loneliness
The UCLA Loneliness Scale (ULS-8) contains 8 items including two factors: intimate other and social other. There are six items in the intimate factor and two items in the social other factor. Observers are asked to answer each item using the following scale: 1=Never, 2=Rarely, 3=Sometimes, 4=Often. It is a 4-point Likert scale with values from "never" to "always". For each participant, responses on the 4-items were totaled to create a composite loneliness score, with higher scores indicated higher loneliness. Scores ranged from 8 to 32. The 8-item measure demonstrated high internal reliability (α=0.84).
Immediate after the intervention
Study Arms (2)
Laughter yoga programme
EXPERIMENTALThe intervention group will receive a 4-week laughter yoga programme (8 sessions). This group also receives routine care provided by the special school as usual.
Routine care
NO INTERVENTIONThe control group receives routine care provided by the special school as usual.
Interventions
Intervention for intervention group: This is a 4-week laughter yoga programme (8 sessions) to help adolescents with intellectual and physical disabilities bring more happiness, laughter and joy to promote their mental health status. As laughter yoga therapy can reduce people's levels of stress, anxiety, depression, loneliness, strengthen the immune system and keep the mind positive. Each laughter yoga session will last for 15 minutes and in total there will be 8 sessions for four weeks (two sessions per week). Each laughter yoga session consists of hand clapping warming-up exercise, followed by deep breathing exercise, childlike playfulness exercise, and then laughter exercise. The intervention group also receives routine care provided by special school.
Eligibility Criteria
You may qualify if:
- Adolescent has been diagnosed with mild and moderate intellectual or/and physical disabilities
- Adolescent is studying between Grade 4 and Grade 12 in the selected special school
- Adolescent aged between 10 and 19 years old in this selected special school during the data collection period
- Adolescent has not received any psychotherapy previously
- Adolescent has the proficiency in understanding instructions for laughter exercises and hands and body movement
You may not qualify if:
- Adolescent has not been diagnosed with mild and moderate intellectual or/and physical disabilities
- Adolescent is studying lower than Grade 4 in the selected special school
- Adolescent aged \< 10 years old and \> 19 years old in this selected special school during the data collection period
- Adolescent has previously received psychotherapy
- Adolescent does not have the proficiency in understanding instructions for laughter exercises and hands and body movement
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Nethersole School of Nursing
Shatin, New Territories, 990777, Hong Kong
Related Publications (1)
Lee RLT, Ho LLK, Lam SKK, Chan DNS, Fung KHK, Hung TTM, Stubbs M, Tang ACY, Choi KC, Leung AWY. The effects of a group-based laughter yoga intervention on mood, anxiety and loneliness in adolescents with mild intellectual or developmental disabilities: A pilot randomized controlled trial. Res Dev Disabil. 2025 Nov;166:105128. doi: 10.1016/j.ridd.2025.105128. Epub 2025 Oct 17.
PMID: 41109062RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Regina Lee, PhD
Chinese University of Hong Kong
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- masking the participants that they do not know which group will be allocated in this pilot study.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 6, 2023
First Posted
April 27, 2023
Study Start
January 27, 2023
Primary Completion
March 26, 2023
Study Completion
March 26, 2023
Last Updated
March 30, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- In 6 months after the submission of the final report.
- Access Criteria
- Once the personal data management account has been set up.
It is anonymous data and it will be shared upon request.