NCT06579118

Brief Summary

This study aimed to assess the impact of laughter yoga intervention on symptomatology and quality of life among postmenopausal women.The research was conducted in a randomized controlled experimental design.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2023

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

August 25, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2024

Completed
Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

4 months

First QC Date

August 28, 2024

Last Update Submit

December 10, 2025

Conditions

Keywords

laughter yogamenopausesymptomquality of life

Outcome Measures

Primary Outcomes (3)

  • Personal Information Form

    It consists of 10 questions (age, gender, education level, marital status, income status, etc.) prepared by the researcher in line with the literature.

    5 months

  • Menopause Rating Scale

    The scale, which includes a total of 11 items including menopausal complaints, consists of 3 sub-dimensions. These sub-dimensions are 1-Somatic complaints sub-dimension (items 1,2,3,11), 2-Psychological complaints sub-dimension (items 4,5,6,7), 3-Urogenital complaints sub-dimension (8,9, Article 10). The scale is a 5-point Likert type and each statement is scored as 0: None, 1: Mild, 2: Moderate, 3: Severe and 4: Very severe. The total score of the scale is calculated based on the scores given for each item. The minimum score that can be obtained from the scale is 0, while the maximum score is 44. An increase in the total score obtained from the scale, on the one hand, indicates an increase in the severity of the complaints experienced, and on the other hand, indicates that the quality of life is negatively affected.

    5 months

  • Menopause-Specific Quality of Life Scale

    It is a Likert type scale containing 29 questions. It consists of four subdomains: vasomotor domain (questions 1-3), psychosocial domain (questions 4-10), physical domain (questions 11-26) and sexual domain (questions 27-29). The complaints that women have experienced in the last month are questioned and the answers to the questions are "yes" or "no". In MÖYÖS, each subdomain score is ranked from 0 to 6. A score of "0" indicates that there are no problems with the issue. A score of "1" indicates that the problem exists and is experienced, but it is not disturbing at all, and scores between "2-6" indicate the severity and increasing degrees of the existing problem. The lowest score that can be obtained from the total of the scale is "0" and the highest score (29X6) is 154. However, evaluation is not made based on the total score.

    5 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

In order to have laughter yoga as a nursing intervention, a "laughter yoga leadership certificate" was obtained by the researcher. Mobile phone numbers were taken to contact the women.Laughter sessions were held in an empty room in the Gynecology outpatient clinic, away from the other rooms indicated by the nurse.A total of 8 sessions of laughter yoga were applied for 4 weeks,2 sessions per week.Before starting laughter yoga, 8 separate WhatsApp groups consisting of approximately 8 people were established to ensure faster and easier communication with women, and information was provided about the sessions and communication was provided. In consultation with the women, the appropriate day, time and program for the session were determined.Sessions will be held twice a week;It was done between 13.00-13.45 on Mondays and Fridays.The sessions were performed in an empty room in the outpatient clinic.A warning sign was hung on the door to avoid being disturbed during the application.

Other: Laughter yoga

Control group

NO INTERVENTION

* Written consent was obtained from pregnant women who agreed to participate in the study. * In order to determine the descriptive characteristics of menopausal women, they were asked to fill out the "Personal Information Form", "Menopause Rating Scale" and "Menopause-Specific Quality of Life Scale". * After 4 weeks, the process was completed by having women in menopause fill out the "Menopause Symptoms Assessment Scale/MSDS" and "Menopause-Specific Quality of Life Scale/MSDS".

Interventions

The women in the experimental group were given laughter yoga sessions by the researcher.

Experimental Group

Eligibility Criteria

Age45 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMenopause women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Entering natural menopause,
  • Being over 45 years old,
  • Being at least a primary school graduate (in order to be able to fill out the forms),
  • Agreeing to participate in the research voluntarily,
  • Not having any hearing or vision problems (in order to be able to perform the sessions),
  • No diagnosed psychiatric disease,
  • Knowing Turkish,
  • Having a smart mobile phone
  • Being open to communication and cooperation.

You may not qualify if:

  • Not continuing with laughter yoga sessions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ayşe Aydın

Yakutiye, Erzurum, 25000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Laughter Therapy

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Study Officials

  • Ayşe Aydın

    Ataturk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Statistics expert
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 28, 2024

First Posted

August 30, 2024

Study Start

August 25, 2023

Primary Completion

December 15, 2023

Study Completion

August 28, 2024

Last Updated

December 17, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations