Disability, Adolescent LearningNCT05832346
Effects of a Laughter Yoga Program in Adolescents With Disabilities
A study testing Laughter yoga programme in people with Disability, Adolescent Learning and Psychosocial Problem, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- Disability, Adolescent Learning, Psychosocial Problem
- What is being tested?
- Laughter yoga programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteHong Kong
- Study dates
- 27 Jan 2023to 26 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
The Nethersole School of Nursing
Shatin, New Territories, 990777
About this study
Official title: 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
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:
Read more
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).
Read the detailed description
Intervention
The purpose of a 4-week laughter yoga programme (8 sessions) combined with mindfulness activities is to help adolescents with intellectual and physical disabilities bring more happiness, laughter and joy to promote their mental health status. As the laughter yoga programme can reduce people's levels of stress, anxiety, loneliness and strengthen the immune system and keep the mind positive.
The elements in the protocol for implementing 15 minutes laughter yoga per session is adopted from the International Laughter Yoga for children with special needs:
- Begins the first exercise: laughing solidly for five minutes with the following body and hands movements. You should keep moving your body.
- Starts pulling faces: trying to emphasize your laughter- everyone should copy and follow.
- Do hand gestures while laughing: Flick both hands and try to shark water off both hands.
- Then apply invisible sun cream to your face.
- Move the body to right and left with both hands up Five minutes pass and the participants should feel exhausted. Then, repeated same steps for two more times with a total of 15 minutes per session each day.
Study participants
The adolescents aged 10-18 years old with intellectual and physical disabilities will be recruited from a special school in Hong Kong. This special school locates in Diamond Hill in Kowloon side of Hong Kong and it is a medium size special school enrolls from mild to moderate students with intellectual and physical disabilities. Forty adolescents with mild to moderate physical and intellectual disabilities (ID) will be randomly allocated to either intervention group or control by the research team with a concealed envelop in a ratio of 1:1.
Study instruments
There are four sessions in this questionnaire including the demographic sheet, Mood Scale, State-Trait Anxiety Inventory (STAI-6), and Loneliness Scale for adolescents.
Data Collection
A briefing session will be delivered to the direct care staff in the school, school nurses and schoolteachers who will assist the participants to complete the questionnaire and demographic sheet with their understanding and behavioural observations.
The data collection will be conducted in both groups before and immediately after the intervention. Pre-test data collection will be conducted one week prior to the intervention. Post-test data collection will be conducted immediately after the intervention for both intervention and control groups.
Data analysis
Appropriate descriptive statistics, such as mean (standard deviation), median (inter-quartile range) and frequency (percentage) will be used to summarize and present the baseline characteristics and outcome data of the participants. Normality of continuous variables will be assessed based on their skewness and kurtosis statistics, values within ±2 indicating the plausibility of normal distribution. Suitable transformations will be made on skewed variables before subjecting them into inferential analysis. Homogeneity of baseline characteristics between the intervention and control groups will be assessed using independent t, chi-square or Fisher's exact tests, as appropriate. Multiple regression will be used to compare the change of each outcome at post-test with respect to pre-test between the two groups with adjustment for the pre-test level. All statistical analyses will be performed using IBM SPSS with level of significance set at 0.05 (2-sided).
- Being tested
- Laughter yoga programme
- Keywords
- disabilities, adolescents, psychosocial problems, laughter yoga, feasibility studies, randomized controlled trial
- Medical subject headings
- Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laughter yoga programmeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Laughter yoga programme |
| Routine care | No intervention | The control group receives routine care provided by the special school as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Immediate after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start27 Jan 2023
- Primary completion26 Mar 2023
- Study completion26 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Disability, Adolescent LearningStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LEE Regina Lai Tong, Chinese University of Hong Kong
- Investigators
- Regina Lee, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05832346
- Sponsor's protocol ID
- 2022.660-T
- Status last verified
- Mar 2026
- First submitted
- 6 Feb 2023
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It is anonymous data and it will be shared upon request.
Publications
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.
PubMed 41109062
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05832346
- Acronym / sponsor ID
- 2022.660-T
- Keywords
- disabilities, adolescents, psychosocial problems, laughter yoga, feasibility studies, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 27 Jan 2023 (actual)
- Primary completion
- 26 Mar 2023 (actual)
- Study completion
- 26 Mar 2023 (actual)
- First posted
- 27 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Intervention
The purpose of a 4-week laughter yoga programme (8 sessions) combined with mindfulness activities is to help adolescents with intellectual and physical disabilities bring more happiness, laughter and joy to promote their mental health status. As the laughter yoga programme can reduce people's levels of stress, anxiety, loneliness and strengthen the immune system and keep the mind positive.
The elements in the protocol for implementing 15 minutes laughter yoga per session is adopted from the International Laughter Yoga for children with special needs:
- Begins the first exercise: laughing solidly for five minutes with the following body and hands movements. You should keep moving your body.
- Starts pulling faces: trying to emphasize your laughter- everyone should copy and follow.
- Do hand gestures while laughing: Flick both hands and try to shark water off both hands.
- Then apply invisible sun cream to your face.
- Move the body to right and left with both hands up Five minutes pass and the participants should feel exhausted. Then, repeated same steps for two more times with a total of 15 minutes per session each day.
Study participants
The adolescents aged 10-18 years old with intellectual and physical disabilities will be recruited from a special school in Hong Kong. This special school locates in Diamond Hill in Kowloon side of Hong Kong and it is a medium size special school enrolls from mild to moderate students with intellectual and physical disabilities. Forty adolescents with mild to moderate physical and intellectual disabilities (ID) will be randomly allocated to either intervention group or control by the research team with a concealed envelop in a ratio of 1:1.
Study instruments
There are four sessions in this questionnaire including the demographic sheet, Mood Scale, State-Trait Anxiety Inventory (STAI-6), and Loneliness Scale for adolescents.
Data Collection
A briefing session will be delivered to the direct care staff in the school, school nurses and schoolteachers who will assist the participants to complete the questionnaire and demographic sheet with their understanding and behavioural observations.
The data collection will be conducted in both groups before and immediately after the intervention. Pre-test data collection will be conducted one week prior to the intervention. Post-test data collection will be conducted immediately after the intervention for both intervention and control groups.
Data analysis
Appropriate descriptive statistics, such as mean (standard deviation), median (inter-quartile range) and frequency (percentage) will be used to summarize and present the baseline characteristics and outcome data of the participants. Normality of continuous variables will be assessed based on their skewness and kurtosis statistics, values within ±2 indicating the plausibility of normal distribution. Suitable transformations will be made on skewed variables before subjecting them into inferential analysis. Homogeneity of baseline characteristics between the intervention and control groups will be assessed using independent t, chi-square or Fisher's exact tests, as appropriate. Multiple regression will be used to compare the change of each outcome at post-test with respect to pre-test between the two groups with adjustment for the pre-test level. All statistical analyses will be performed using IBM SPSS with level of significance set at 0.05 (2-sided).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laughter yoga programme | Experimental | Behavioral: Laughter yoga programmeThe 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 intervention | –The control group receives routine care provided by the special school as usual. |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laughter yoga programmeIntervention 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. | Behavioural | Laughter yoga programme |
Primary outcome
Mood
Time frame: Before the intervention
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.
Mood
Time frame: Immediate after the intervention
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.
Anxiety
Time frame: Before the intervention
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).
Anxiety
Time frame: Immediate after the intervention
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).
Loneliness
Time frame: Before the intervention
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).
Loneliness
Time frame: Immediate after the intervention
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Results publication: PubMed 41109062Lee 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.
- Individual participant dataSharing planned: Yes. It is anonymous data and it will be shared upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Regina Lee, PhD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laughter yoga programme in people with Disability, Adolescent Learning and Psychosocial Problem, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mood (time frame: Before the intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05832346, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.