NCT06685731

Brief Summary

Objective: The study aims to evaluate the effects of Laughter Yoga on sleep quality, vitality, active aging, and quality of life in individuals aged 60 and over. Method: This randomized controlled experimental study will be conducted between 01.09.2024 and 31.12.2024 with elderly individuals aged 60 and over who are registered at Şavşat Family Health Center No. 1. The study population consists of 6,797 individuals. Participants will be randomly assigned to an experimental group (30) and a control group (30) using a simple randomization method. Data will be collected using a Personal Information Form, Mini-Mental State Examination, Active Aging Scale, Pittsburgh Sleep Quality Index, Subjective Vitality Scale, and Quality of Life Scale for the Elderly. The experimental group will participate in 12 Laughter Yoga sessions, conducted twice a week for 6 weeks, with each session lasting 40 minutes. No intervention will be applied to the control group. At the end of the 6th week, final measurements will be taken from both groups at the family health center.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

September 5, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

September 5, 2024

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 12, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

November 12, 2024

Status Verified

September 1, 2024

Enrollment Period

4 days

First QC Date

September 5, 2024

Last Update Submit

November 11, 2024

Conditions

Keywords

elderlyLaughter YogaSleep QualityVitalityActive AgingElderly Quality of Life

Outcome Measures

Primary Outcomes (1)

  • Pre-test

    Mini Mental State Test (MMST): Assesses cognitive function on a 0-30 scale; higher scores indicate better cognitive function. The score will be reported independently.

    Initial enrollment in the study

Secondary Outcomes (4)

  • Active Aging Scale

    From enrollment to the end of treatment at 6 weeks

  • Pittsburgh Sleep Quality Index (PSQI)

    From enrollment to the end of treatment at 6 weeks

  • Subjective Vitality Scale (SVS)

    From enrollment to the end of treatment at 6 weeks

  • CASP-13 Quality of Life Scale

    From enrollment to the end of treatment at 6 weeks

Study Arms (2)

Participant Group

EXPERIMENTAL

Personal Information Form, Mini-Mental State Examination, Active Aging Scale, Pittsburgh Sleep Quality Index, Subjective Vitality Scale, and Quality of Life Scale for Elderly Individuals will be administered to elderly individuals via face-to-face interviews conducted by the researcher. Elderly individuals will be provided with information about the Laughter Yoga sessions. The elderly participants will undergo a total of 12 Laughter Yoga sessions, with each session lasting 40 minutes, conducted twice a week for 6 weeks. Participants' phone numbers will be collected, and they will be contacted twice a week to ensure their attendance at the Laughter Yoga sessions.

Other: Laughter Yoga

Control group

NO INTERVENTION

Personal Information Form, Mini-Mental State Examination, Active Aging Scale, Pittsburgh Sleep Quality Index, Subjective Vitality Scale, and Quality of Life Scale for the Elderly will be administered to elderly individuals through face-to-face interviews conducted by the researcher. No intervention will be applied to the elderly individuals in this group. Phone numbers of the participants in this group will be collected, and they will be contacted once a week to check on their status.

Interventions

Laughter Yoga Intervention: Laughter Yoga is composed of four stages: deep breathing exercises, clapping and warm-up exercises, childlike play, and laughter exercises. These stages are designed to remove barriers to laughter, enhance emotional expression through childlike play, and prepare the lungs for laughter exercises. Before the Laughter Yoga session begins, participants will be introduced to both the practice itself and to Laughter Yoga in general. The session will then proceed according to the following structure: Deep Breathing Exercises: Participants inhale through the nose for 4-5 seconds, hold their breath for 2-3 seconds, and exhale through the mouth, with lips pursed, for one second longer than the inhalation, while smiling or laughing. This exercise is performed for 10-15 minutes. Clapping and Warm-Up Exercises: Participants clap with palms and fingertips touching, keeping their hands parallel. This stimulates acupressure points in the hands. To increase group energy, a

Also known as: Laughter Therapy
Participant Group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Reside in Şavşat,
  • Aged 60 or over,
  • No issues with vision, hearing, or perception,
  • Scored 24 or higher on the Mini-Mental State Examination,
  • Not undergoing psychiatric treatment,
  • No physical limitations that would impede participation in laughter yoga (e.g., fractures, open wounds, or muscle weakness in the hands, wrists, or arms),
  • Literate,
  • Open to communication,
  • Willing to participate in the study.

You may not qualify if:

  • Scored below 24 on the Mini-Mental State Examination,
  • Severe hearing or perceptual impairments that hinder communication,
  • Major psychiatric disorders,
  • Underwent surgery within the last three months,
  • Medical conditions that could cause physical strain or increase abdominal pressure during laughter yoga (e.g., bleeding hemorrhoids, any type of hernia, persistent cough, severe back pain, heart disease, hypertension, urinary incontinence, epilepsy), and individuals with oncological conditions will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Şavşat 1St Family Health Center

Artvin, Şavşat, 08700, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Study Officials

  • Mehtap Tan, Prof. Dr.

    Atatürk Universty

    STUDY DIRECTOR

Central Study Contacts

Mehtap Tan, Prof. Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

September 5, 2024

First Posted

November 12, 2024

Study Start

September 5, 2024

Primary Completion

September 9, 2024

Study Completion

December 31, 2024

Last Updated

November 12, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations