NCT07435545

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet 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

February 22, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2026

Completed
Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

28 days

First QC Date

February 22, 2026

Last Update Submit

February 26, 2026

Conditions

Keywords

Laughter YogaMenopauseMenopausal SymptomsSleep QualityQuality of LifeNon-Pharmacological InterventionWomen's HealthMenopausal Women

Outcome Measures

Primary Outcomes (1)

  • Change in Menopausal Symptoms

    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.

    Baseline and immediately after the 4-week intervention

Secondary Outcomes (2)

  • Change in Sleep Quality

    Baseline and immediately after the 4-week intervention

  • Change in Menopause-Specific Quality of Life

    Baseline and immediately after the 4-week intervention

Study Arms (2)

Laughter Yoga Intervention Group

EXPERIMENTAL

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.

Behavioral: Laughter Yoga

Control Group

NO INTERVENTION

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.

Interventions

Laughter YogaBEHAVIORAL

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.

Also known as: Laughter Therapy
Laughter Yoga Intervention Group

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mamak Aile Merkezleri

Ankara, Ankara, 06260, Turkey (Türkiye)

Location

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

  • Prof.Dr. Gülten Güvenç, PhD

    Saglik Bilimleri Universitesi

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Derya UZUNCA, BSc, RN

CONTACT

Prof. Dr. Gülten Güvenç, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will not know which group they belong to. Laughter yoga will be administered to the experimental group on the day of the final test. By having both groups receive laughter yoga, participants will be prevented from knowing which group they belong to, thereby reducing the possibility of bias.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to two groups: the intervention group and the control group. A pre-test will be conducted to assess menopause symptoms, sleep quality, and quality of life. While the intervention group will receive eight sessions of laughter yoga, the control group will not receive any intervention during the study period. A final test will be conducted in both groups to assess changes in menopause symptoms, sleep quality, and quality of life. After the final assessments are completed, the control group will also receive the laughter yoga intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's Student

Study Record Dates

First Submitted

February 22, 2026

First Posted

February 27, 2026

Study Start

March 1, 2026

Primary Completion

March 29, 2026

Study Completion

March 29, 2026

Last Updated

March 2, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) underlying the results reported in publications, including the analyzable data set, will be shared if the study results are published.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Beginning 6 months after publication (if published) and available for up to 5 years upon reasonable request.
Access Criteria
Access to de-identified individual participant data (IPD), the study protocol, and the statistical analysis plan will be granted to qualified researchers who provide a methodologically sound proposal. Requests must be submitted to the corresponding investigator via institutional email. Data will be shared in a de-identified format after approval of the proposal and completion of a data use agreement to ensure protection of participant confidentiality.

Locations