The Impact of Laughter Yoga on Symptom Management and Quality of Life in Postmenopausal Women

NCT ID: NCT06579118

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-25

Study Completion Date

2024-08-28

Brief Summary

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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.

Detailed Description

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The population of the research consisted of menopausal women who applied to the Gynecology Polyclinic of Atatürk University Health Research and Application Center between 25.08.2023 and 15.12.2023. To determine the sample size of the study, a priori power analysis was performed in the G\* Power 3.1.9.7 program. Based on the medium effect size (0.5), the alpha value was determined as 5% and the theoretical power was determined as 95%, and the minimum sample size was determined as 64. The sample of the study consisted of 128 women, 64 experimental and 64 control, who met the research criteria and agreed to participate in the research. However, since 8 people in the experimental group could not continue laughter yoga, the study was completed with 120 women.

Criteria for inclusion in the study

* 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.

Exclusion criteria from the study

• Not continuing with laughter yoga sessions.

Data were collected using the "Personal Information Form," "Menopause Rating Scale," and "Menopause-Specific Quality of Life Scale." Laughter yoga was used as an intervention tool in the research.Participants in the experimental group underwent laughter yoga sessions twice weekly for four weeks, totaling eight sessions.

The data were collected by the researcher through a face-to-face interview in a suitable empty room at Atatürk University Health Research and Application Center Gynecology Polyclinic. In order to enable women to answer the questions comfortably, each woman was interviewed alone in a separate room in the relevant outpatient clinic. Application of the questionnaire and scales took an average of 10-15 minutes for each woman. Before starting the research, women were informed about the purpose, method, rights and responsibilities of the research.

Process steps experimental group

* Written consent was obtained from menopausal women who agreed to participate in the study.
* 10 minutes before starting the laughter yoga, women in menopause were asked to fill out the \"Personal Information Form\", \"Menopause Rating Scale\" and \"Menopause-Specific Quality of Life Scale\" in order to determine their descriptive characteristics.
* A total of 8 sessions of laughter yoga were applied for 4 weeks, 2 sessions per week. The first session lasted 45 minutes, all other sessions lasted an average of 30 minutes. In the first session, laughter yoga, its history, benefits, breathing techniques, laughter yoga exercises were mentioned before the exercises, and in the following sessions, reminders were made and the session ended with laughter yoga exercises and breathing exercises.
* After 4 weeks, the process was completed by having women in menopause fill out the \"Menopause Rating Scale\" and the \"Menopause-Specific Quality of Life Scale\".

control group

* 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 Symptoms Evaluation Scale\" and \"Menopause-Specific Quality of Life Scale\".
* After 4 weeks, the process was completed by having women in menopause fill out the \"Menopause Rating Scale\" and \"Menopause-Specific Quality of Life Scale\".

Data analysis included Skewness and Kurtosis values, frequency and percentage distributions, Chi-square tests, Independent Samples t-test, Paired Samples t-test, Mann-Whitney U test, Wilcoxon signed-rank test, and regression analysis. All ethical principles were adhered to throughout the study.

Conditions

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Menopause

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
Statistics expert

Study Groups

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Experimental Group

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.

Group Type EXPERIMENTAL

Laughter yoga

Intervention Type OTHER

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

Control group

* 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".

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Laughter yoga

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Not continuing with laughter yoga sessions.
Minimum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ataturk University

OTHER

Sponsor Role lead

Responsible Party

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Ayse Aydin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayşe Aydın

Role: PRINCIPAL_INVESTIGATOR

Ataturk University

Locations

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Ayşe Aydın

Yakutiye, Erzurum, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Tuba Çelik

Identifier Type: -

Identifier Source: org_study_id