- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07435545
Effect of Laughter Yoga on Menopausal Symptoms, Sleep, and Quality of Life in Menopausal Women
Evaluation of the Effects of Laughter Yoga on Menopausal Symptoms, Sleep, and Quality of Life in Menopausal Women
This study aims to provide meaningful contributions to both academic literature and clinical nursing practice by examining laughter yoga, a non-pharmacological, evidence-based, and feasible intervention for quality of life and sleep problems commonly encountered during menopause. Menopause is a natural stage of life that can be associated with physical and psychological symptoms affecting daily life. Laughter yoga, a group-based complementary method, is based on the philosophy that "movement creates emotion" and aims to transform voluntary laughter into natural and genuine laughter over time. Laughter yoga consists of clapping and warm-up exercises, childlike games, deep breathing techniques, laughter exercises, and meditation stages. Thanks to its physiological and psychological effects, it supports individuals' overall well-being.
In this study, participants will be divided into two groups: an intervention group and a control group. A pre-test will be administered to both groups to assess menopause symptoms, sleep quality, and quality of life. The intervention group will undergo eight sessions of laughter yoga, while the control group will not receive any intervention during the study period. A post-test will be administered to both groups after the intervention to evaluate its effectiveness.
The results of the study are expected to contribute to determining whether laughter yoga is an effective supportive approach during menopause. It is particularly important in terms of establishing a scientific basis for the integration of complementary treatment approaches into the menopause period and ensuring that they can be integrated with nursing care.
Study Overview
Detailed Description
This study is designed as a controlled trial involving women in the menopause period, with participants individually randomized using a simple randomization method. The study will be conducted at a family health center affiliated with the Mamak Cultural Center Coordination in Ankara, Turkey.
Eligible participants will be randomly assigned to either the laughter yoga intervention group or the control group at a 1:1 ratio using a computer-generated randomization sequence. Following the pre-test, the intervention group will receive a total of eight laughter yoga sessions over four weeks, twice a week. No intervention will be administered to the control group during the study period.
Menopause symptoms, sleep quality, and menopause-specific quality of life will be assessed using pre-test and post-test measurements. This study aims to determine the effect of laughter yoga on changes experienced during menopause and on sleep and quality of life.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Derya UZUNCA, BSc, RN
- Phone Number: +905071720400
- Email: deryauzunca673@gmail.com
Study Contact Backup
- Name: Prof. Dr. Gülten Güvenç, PhD
- Email: gulten.guvenc@sbu.edu.tr
Study Locations
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Ankara
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Ankara, Ankara, Turkey (Türkiye), 06260
- Mamak Aile Merkezleri
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Contact:
- Derya Uzunca, BSc, RN
- Phone Number: 5071720400
- Email: deryauzunca673@gmail.com
-
Contact:
- Prof.Dr. Gülten Güvenç, PhD
- Email: gulten.guvenc@sbu.edu.tr
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Sub-Investigator:
- Derya UZUNCA, BSc, RN
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being in the menopause period
- Having sufficient proficiency in understanding and expressing oneself in Turkish
- Agreeing to participate in the study
- Having physical and cognitive competence
- Not having a diagnosis of mental disorder
- Not using hormone therapy or complementary treatments for menopause symptoms
Exclusion Criteria:
- Not participating in laughter yoga sessions
- Withdrawing from the study during the research phase
- Incomplete filling out of data collection forms
- Having contraindications for laughter yoga (Bleeding hemorrhoids, psychiatric disorders, epilepsy, undergoing surgery within the last 3 months, and similar conditions)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Laughter Yoga Intervention Group
Participants in the experimental group will undergo a pre-test to assess menopause symptoms, sleep, and quality of life.
After 8 sessions of laughter yoga over 4 weeks, a post-test will be administered to reassess menopause symptoms, sleep, and quality of life.
|
The intervention consists of a total of 8 laughter yoga sessions, with 2 sessions per week for four weeks.
Each laughter yoga session is planned to last an average of 20 minutes.
Each session will begin with clapping and warm-up exercises and continue with childlike games, deep breathing exercises, and laughter exercises.
It will end with meditation.
It is a group-based practice, and the aim is to increase psychosocial well-being by transforming fake laughter into real laughter and to benefit from the physiological effects of laughter.
Other Names:
|
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No Intervention: Control Group
Arm Description: No intervention will be applied to participants in this group during the study period.
A pre-test will be administered at the beginning and a post-test will be administered after 4 weeks to assess menopause symptoms, sleep quality, and quality of life.
After the final test, laughter yoga will be practiced to prevent participant bias.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Menopausal Symptoms
Time Frame: Baseline and immediately after the 4-week intervention
|
Menopause symptoms will be assessed using the Menopause Rating Scale (MRS).
Changes in total MRS scores from baseline to post-intervention will be compared between the intervention group and the control group.
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Baseline and immediately after the 4-week intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Sleep Quality
Time Frame: Baseline and immediately after the 4-week intervention
|
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI).
Changes in PSQI scores at baseline and after the 4-week intervention will be compared between groups.
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Baseline and immediately after the 4-week intervention
|
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Change in Menopause-Specific Quality of Life
Time Frame: Baseline and immediately after the 4-week intervention
|
Quality of life will be assessed using the Menopause-Specific Quality of Life Questionnaire (MENQOL).
Changes in MENQOL scores at baseline and after the 4-week intervention will be compared between the intervention and control groups.
|
Baseline and immediately after the 4-week intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Prof.Dr. Gülten Güvenç, PhD, Saglik Bilimleri Universitesi
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-033
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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