NCT05832346

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 27, 2023

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 27, 2023

Completed
Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

February 6, 2023

Last Update Submit

March 25, 2026

Conditions

Keywords

disabilitiesadolescentspsychosocial problemslaughter yogafeasibility studiesrandomized controlled trial

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

EXPERIMENTAL

The 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.

Behavioral: Laughter yoga programme

Routine care

NO INTERVENTION

The 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.

Laughter yoga programme

Eligibility Criteria

Age10 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

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

Location

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.

MeSH Terms

Conditions

Learning Disabilities

Condition Hierarchy (Ancestors)

Communication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Regina Lee, PhD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

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

It is anonymous data and it will be shared upon request.

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.

Locations