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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).
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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Routine care | No Intervention | The control group receives routine care provided by the special school as usual. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laughter yoga programme | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Regina Lee, PhD | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Nethersole School of Nursing | Shatin | New Territories | 990777 | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41109062 | Result | 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. |
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It is anonymous data and it will be shared upon request.
In 6 months after the submission of the final report.
Once the personal data management account has been set up.
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| ID | Term |
|---|---|
| D007859 | Learning Disabilities |
| ID | Term |
|---|---|
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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masking the participants that they do not know which group will be allocated in this pilot study.
|
| 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 |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |