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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Anxiety
研究概览
简要总结
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).
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
masking the participants that they do not know which group will be allocated in this pilot study.
入排标准
- 年龄范围
- 10 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Anxiety
时间窗: 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).
Mood
时间窗: 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.
Loneliness
时间窗: 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).
次要结局
未报告次要终点
研究者
LEE Regina Lai Tong
Professor
Chinese University of Hong Kong