Feasibility & Effects of Laughter-imitation Therapy (LIT)

Status Recruiting

Clinical Trial Summary

Background: The mental wellbeing of the institutional population has to be promoted, particularly after the serious hit by the pandemic. Objectives: 1. To develop a LIT intervention to promote mental wellbeing of institutional older adults 2. To explore the feasibility and acceptability of such intervention; 3. 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Aging Well

Clinical Trial Details

NCT number	NCT06204562
Study type	Interventional
Source	The University of Hong Kong
Contact	Pui Hing Chau, PhD
Phone	39176626
Email	phpchau@hku.hk
Status	Recruiting
Phase	N/A
Start date	August 16, 2023
Completion date	January 31, 2026

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Feasibility and Effects of Laughter-imitation Therapy (LIT)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms