Clinical trial NCT06204562: Feasibility and Effects of Laughter-imitation Therapy (LIT)
Official title: Feasibility and Effects of Laughter-imitation Therapy (LIT) in Promoting Mental Wellbeing Among Institutional Older Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aging Well
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

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).

Exclusion Criteria:

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).

Primary outcomes:
measure: Participation rate of laughter-imitation therapy (LIT)
timeFrame: 16 weeks after baseline
measure: Compliance rate of laughter-imitation therapy (LIT)
timeFrame: 16 weeks after baseline
measure: Acceptance of laughter-imitation therapy (LIT)
timeFrame: 16 weeks after baseline
Secondary outcomes:
measure: Change from baseline mental wellbeing at 4 weeks
timeFrame: 4 weeks after baseline
measure: Change from baseline mental wellbeing at 8 weeks
timeFrame: 8 weeks after baseline
measure: Change from baseline mental wellbeing at 12 weeks
timeFrame: 12 weeks after baseline
measure: Change from baseline mental wellbeing at 16 weeks
timeFrame: 16 weeks after baseline
measure: Change from baseline subjective happiness at 4 weeks
timeFrame: 4 weeks after baseline
measure: Change from baseline subjective happiness at 8 weeks
timeFrame: 8 weeks after baseline
measure: Change from baseline subjective happiness at 12 weeks
timeFrame: 12 weeks after baseline
measure: Change from baseline subjective happiness at 16 weeks
timeFrame: 16 weeks after baseline
measure: Change from baseline depressive symptoms at 4 weeks
timeFrame: 4 weeks after baseline
measure: Change from baseline depressive symptoms at 8 weeks
timeFrame: 8 weeks after baseline
measure: Change from baseline depressive symptoms at 12 weeks
timeFrame: 12 weeks after baseline
measure: Change from baseline depressive symptoms at 16 weeks
timeFrame: 16 weeks after baseline
measure: Change from baseline sleep quality at 4 weeks
timeFrame: 4 weeks after baseline
measure: Change from baseline sleep quality at 8 weeks
timeFrame: 8 weeks after baseline
measure: Change from baseline sleep quality at 12 weeks
timeFrame: 12 weeks after baseline
measure: Change from baseline sleep quality at 16 weeks
timeFrame: 16 weeks after baseline
measure: Change from baseline pain experience at 4 weeks
timeFrame: 4 weeks after baseline
measure: Change from baseline pain experience at 8 weeks
timeFrame: 8 weeks after baseline
measure: Change from baseline pain experience at 12 weeks
timeFrame: 12 weeks after baseline
measure: Change from baseline pain experience at 16 weeks
timeFrame: 16 weeks after baseline
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Community
Study officials:
affiliation: School of Nursing, The University of Hong Kong
name: Pui Hing Chau, PhD
role: PRINCIPAL_INVESTIGATOR
References: