Feasibility and Effects of Laughter-imitation Therapy (LIT) in Promoting Mental Wellbeing Among Institutional Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Acceptance of laughter-imitation therapy (LIT)
研究概览
简要总结
Background: The mental wellbeing of the institutional population has to be promoted, particularly after the serious hit by the pandemic.
Objectives:
- To develop a LIT intervention to promote mental wellbeing of institutional older adults
- To explore the feasibility and acceptability of such intervention;
- To explore the potential effect of the intervention
Design and subject:
A pilot cluster randomized control trial will be conducted. The target population is institutional older adults. About 30 participants will be recruited from 2 nursing homes. The intervention is one-month imitated laughter practice. Each practice session lasts for 3 minutes once a day, giving a total of 21 minutes per week and the waitlist control group will be under usual care for the first 8 weeks. Then, they will start intervention after the 8 week, and receive two additional outcome assessments. A brief one-to-one training will be offered and a trained research assistant (RA1). Further in-person demonstration and return demonstration will be conducted until participant is able to demonstrate the Duchenne smile on their own. RA1 will be on-site for two days in the first week and one day in the second week to support the participants. At the end of the intervention, qualitative feedback will be collected from purposive sample until data saturation.
Instruments: Chinese version including the World Health Organization Five Well-Being Index (WHO-5), 4-item Subjective Happiness Scale (SHS), Geriatric Depression Scale (GDS), Pittsburgh Sleep Quality Index (PSQI), 5-min Montreal Cognitive Assessment, FRAIL scale, Geriatric Adverse Life Events Scale (GALES).
Main outcome measures: Feasibility and acceptability of laughter-imitation therapy (LIT)
Data analysis: Descriptive statistics will be calculated for participants' characteristics, practice frequency, satisfaction, and health outcomes. Linear mixed-effects models will be used to evaluate health outcomes. Content analysis will be conducted for qualitative feedback.
Expected results: The intervention is expected to be feasible and acceptable to institutional older adults as a means for promoting mental wellbeing, and potential beneficial effects will be demonstrated.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •i. aged ≥65 years, ii. living in institutions for ≥6 months and will continue to live there for ≥6 months, iii. no communication problems, iv. cognitively capable (screened by 5-min Montreal Cognitive Assessment (MoCA) > age-and-education specific cutoff at 7th-percentile).
排除标准
- •i. facial paralysis or paralysed Zygomaticus major muscle or orbicularis oculi muscle, ii. hearing problem that prevent them from following audio recording, iii. undergoing oxygen therapy that may hinder their practice, iv. those with undiagnosed depression but is detected by screening with Geriatric Depression Scale ≥ 8 (they will be referred to professional service).
结局指标
主要结局
Acceptance of laughter-imitation therapy (LIT)
时间窗: 16 weeks after baseline
To measure acceptance, level of satisfaction with the intervention will be collected by a single question with five point likert scale.
Participation rate of laughter-imitation therapy (LIT)
时间窗: 16 weeks after baseline
To reflect feasibility, the participation rate, calculated by dividing the number of participants joining the study by the number of participants invited, will be calculated.
Compliance rate of laughter-imitation therapy (LIT)
时间窗: 16 weeks after baseline
To calculate the compliance rate, the number of practiced session divided by the number of scheduled session will be estimated. The participants will use a log book (Appendix V) to record their daily practice of self-induced laughter.
次要结局
- Change from baseline subjective happiness at 4 weeks(4 weeks after baseline)
- Change from baseline subjective happiness at 16 weeks(16 weeks after baseline)
- Change from baseline mental wellbeing at 4 weeks(4 weeks after baseline)
- Change from baseline depressive symptoms at 4 weeks(4 weeks after baseline)
- Change from baseline depressive symptoms at 16 weeks(16 weeks after baseline)
- Change from baseline subjective happiness at 12 weeks(12 weeks after baseline)
- Change from baseline depressive symptoms at 8 weeks(8 weeks after baseline)
- Change from baseline mental wellbeing at 8 weeks(8 weeks after baseline)
- Change from baseline mental wellbeing at 12 weeks(12 weeks after baseline)
- Change from baseline mental wellbeing at 16 weeks(16 weeks after baseline)
- Change from baseline subjective happiness at 8 weeks(8 weeks after baseline)
- Change from baseline depressive symptoms at 12 weeks(12 weeks after baseline)
- Change from baseline sleep quality at 8 weeks(8 weeks after baseline)
- Change from baseline pain experience at 4 weeks(4 weeks after baseline)
- Change from baseline pain experience at 8 weeks(8 weeks after baseline)
- Change from baseline sleep quality at 4 weeks(4 weeks after baseline)
- Change from baseline sleep quality at 12 weeks(12 weeks after baseline)
- Change from baseline sleep quality at 16 weeks(16 weeks after baseline)
- Change from baseline pain experience at 12 weeks(12 weeks after baseline)
- Change from baseline pain experience at 16 weeks(16 weeks after baseline)
研究者
Dr. Pui-Hing Chau
Associate Professor
The University of Hong Kong