Feasibility and Effects of Laughter-imitation Therapy (LIT)

NCT ID: NCT06204562

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-06
• Study Completion Date: 2026-01-31

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.

Conditions

Aging Well

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

one-month imitated laughter practice

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. 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.

Group Type: EXPERIMENTAL

imitated laughter practice

Intervention Type: BEHAVIORAL

To imitate laughter, participants will practice "Duchenne smile", which is reported to associate with positive emotion in people producing it If participants cannot imitate a Duchenne smile, they can hold a chopstick horizontally in their mouth tightly. To help timing the 3-minute and to enhance adherence, an audio recording with joyous music and vocal instruction will be played alongside the practice. Versions with or without laugh voice will be prepared for their preferences. A logbook will be given to each participant to record their practice. To remind participants to practise, a reminder will be made each day through the public announcement system of the respective nursing home, and the audio guide will be played.

waitlist control

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.

Group Type: EXPERIMENTAL

imitated laughter practice

Intervention Type: BEHAVIORAL

To imitate laughter, participants will practice "Duchenne smile", which is reported to associate with positive emotion in people producing it If participants cannot imitate a Duchenne smile, they can hold a chopstick horizontally in their mouth tightly. To help timing the 3-minute and to enhance adherence, an audio recording with joyous music and vocal instruction will be played alongside the practice. Versions with or without laugh voice will be prepared for their preferences. A logbook will be given to each participant to record their practice. To remind participants to practise, a reminder will be made each day through the public announcement system of the respective nursing home, and the audio guide will be played.

Interventions

imitated laughter practice

To imitate laughter, participants will practice "Duchenne smile", which is reported to associate with positive emotion in people producing it If participants cannot imitate a Duchenne smile, they can hold a chopstick horizontally in their mouth tightly. To help timing the 3-minute and to enhance adherence, an audio recording with joyous music and vocal instruction will be played alongside the practice. Versions with or without laugh voice will be prepared for their preferences. A logbook will be given to each participant to record their practice. To remind participants to practise, a reminder will be made each day through the public announcement system of the respective nursing home, and the audio guide will be played.

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Dr. Pui-Hing Chau

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pui Hing Chau, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Nursing, The University of Hong Kong

Locations

Community

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

UW 23-424

Identifier Type: -

Identifier Source: org_study_id