Feasibility and Effects of Laughter-imitation Therapy (LIT)

NCT06204562 | Active Not Recruiting

• 1 other identifier: UW 23-424
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The mental wellbeing of the institutional population has to be promoted, particularly after the serious hit by the pandemic. Objectives:

1. 1.To develop a LIT intervention to promote mental wellbeing of institutional older adults
2. 2.To explore the feasibility and acceptability of such intervention;
3. 3.To explore the potential effect of the intervention

Conditions

Aging Well

Outcome Measures

Primary Outcomes (3)

• Participation rate of laughter-imitation therapy (LIT)

  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.

  16 weeks after baseline

• Compliance rate of laughter-imitation therapy (LIT)

  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.

  16 weeks after baseline

• Acceptance of laughter-imitation therapy (LIT)

  To measure acceptance, level of satisfaction with the intervention will be collected by a single question with five point likert scale.

  16 weeks after baseline

Secondary Outcomes (20)

• Change from baseline mental wellbeing at 4 weeks

  4 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 4 weeks

  4 weeks after baseline

Study Arms (2)

one-month imitated laughter practice

EXPERIMENTAL

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.

Behavioral: imitated laughter practice

waitlist control

EXPERIMENTAL

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.

Behavioral: imitated laughter practice

Interventions

imitated laughter practice 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.

one-month imitated laughter practice; waitlist control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Community

Hong Kong, Hong Kong

Location

Study Officials

• Pui Hing Chau, PhD

  School of Nursing, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 12, 2024
• Study Start: September 6, 2023
• Primary Completion: August 31, 2025
• Study Completion: January 31, 2026
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)