NCT06722872

Brief Summary

This study was designed and conducted as a randomized controlled experimental research with a pre-test and post-test control group to evaluate the effect of laughter therapy on psychological well-being, life satisfaction, and mental health of elderly individuals living in a nursing home.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 16, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 9, 2024

Completed
Last Updated

December 10, 2024

Status Verified

December 1, 2024

Enrollment Period

1 month

First QC Date

December 3, 2024

Last Update Submit

December 7, 2024

Conditions

Keywords

Laughter therapyOld agePsychological well-beingLife satisfactionMental health

Outcome Measures

Primary Outcomes (3)

  • Psychological Well-Being Scale for Older Adults

    The scale was used to measure the psychological well-being levels of older adults. It consists of 15 items in a 5-point Likert format (1 = Strongly Disagree to 5 = Strongly Agree). No specific cutoff score has been determined for the well-being levels of older adults. Higher scores indicate an increase in the level of well-being. The minimum score obtainable from the scale is 15, while the maximum score is 75.

    Pre-test, Post-test (6th week), Follow-up Test (4th week)

  • Life Satisfaction Scale for Older Adults

    The scale was used to assess the participation of older adults in the process of life satisfaction. It consists of 14 items across 3 subdimensions and is structured as a 5-point Likert scale (1 = Strongly Disagree to 5 = Strongly Agree). The scale includes 9 items under the "Self-Acceptance" subdimension, 2 items under the "Motivation" subdimension, and 3 items under the "Peace" subdimension. Scores range from 14 to 70, with individual subdimension scores calculated by dividing the total score by the number of items in each subdimension. The "Self-Acceptance" subdimension ranges from 9 to 45, the "Motivation" subdimension from 2 to 10, and the "Peace" subdimension from 3 to 15.

    Pre-test, Post-test (6th week), Follow-up Test (4th week)

  • Depression Anxiety Stress Scale (DASS-21)

    The scale was used to assess the mood of older adults by identifying their levels of depression, anxiety, and stress. DASS-21 is a shortened version of the 42-item Depression Anxiety Stress Scale. It consists of 21 items in a 4-point Likert format (0 = Never, 1 = Sometimes, 2 = Often, 3 = Always) and includes three subdimensions: depression, anxiety, and stress. Each subdimension is measured by 7 questions.

    Pre-test, Post-test (6th week), Follow-up Test (4th week)

Study Arms (2)

Laughter therapy group

EXPERIMENTAL

Pre-tests were collected 10 days before the therapy began. The elderly participants were introduced individually and informed face-to-face about laughter therapy. Therapy sessions were conducted face-to-face twice a week, with a total of 12 sessions. Each laughter therapy session lasted 50 minutes. Post-tests were collected immediately after the final therapy session. Four weeks later, follow-up tests were also conducted face-to-face.

Other: Laughter therapy

No intervention group

NO INTERVENTION

The control group did not receive laughter therapy; they continued with routine nursing home care. Pre-tests, post-tests, and follow-up tests were collected on the same days as the experimental group. After the follow-up tests were completed, a 30-minute laughter therapy session was provided to control group participants who wished to participate.

Interventions

Laughter therapy, developed by Dr. Madan Kataria in 1995, is a structured exercise program use of laughter and breathing exercises.Laughter therapy sessions begin with warm-up techniques, including clapping, singing, and stretching movements. These are followed by breathing exercises to prepare the lungs for laughter. After the breathing exercises, laughter is simulated using acting techniques. Shortly thereafter, the simulated laughter spreads from person to person through group dynamics, transforming into genuine laughter, which is then followed by a series of laughter exercises. A laughter therapy session may conclude with laughter meditation, during which participants allow natural laughter to flow freely, followed by guided relaxation exercises. To maximize the benefits of laughter's contagious nature, it is recommended that laughter therapy be conducted in groups. Each session varies depending on the target audience, typically lasting around 45 minutes.

Laughter therapy group

Eligibility Criteria

Age65 Years - 105 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Being over the age of 65
  • Scoring ≥ 18 points on the Mini-Mental Examination
  • Having the ability to communicate
  • Not having participated in a laughter therapy session before

You may not qualify if:

  • Having severe hearing or perception impairment that hinders communication
  • Having a physical or psychological condition that prevents participation in therapy
  • Having moderate-to-severe Alzheimer's disease, uncontrolled hypertension, epilepsy, abdominal surgery within the past 3 months, or a surgical procedure with a risk of bleeding
  • Choosing not to continue participating in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KASEV Huzurevi

Istanbul, Tuzla, 34948, Turkey (Türkiye)

Location

MeSH Terms

Conditions

LaughterPersonal SatisfactionPsychological Well-Being

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Nonverbal CommunicationCommunicationBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
In order to prevent selection bias in the study, the assignment to the experimental and control groups will be made on a computer by a person who is unfamiliar with the research process. Individuals included in the study will not be told whether they are in the experimental or control group. The analysis of the data will be done by a statistics expert who is outside the research process.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Two groups with experimental and control groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Asisstant

Study Record Dates

First Submitted

December 3, 2024

First Posted

December 9, 2024

Study Start

April 16, 2024

Primary Completion

May 26, 2024

Study Completion

June 26, 2024

Last Updated

December 10, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations