Menopause, Laughter Therapy, and Well-Being

April 18, 2026 updated by: NURTEN ÖZÇALKAP, Agri Ibrahim Cecen University

The Effect of Laughter Therapy on Brain Fog, Psychological Well-Being, and Sleep Quality in Women During Menopause

The intervention will be conducted by Assist. Prof. Dr. Nurten ÖZÇALKAP. No invasive procedures will be performed; participants will engage in deep breathing, warm-up exercises, playful activities, and laughter exercises. The researcher holds an internationally certified training in laughter therapy.

Intervention Group

Participants will be invited face-to-face, informed about the study, and provide consent. They will be assigned to groups of 8 - 9 and receive laughter yoga twice weekly for a total of 8 sessions (20-40 minutes each) in a suitable hospital or institutional setting.

Baseline assessments will include the Introductory Information Form, Brain Fog Scale, Psychological Well-Being Scale, and Sleep Quality Scale. These scales will be re-administered after the 8th session.

Control Group Participants will be recruited similarly and provide consent. Baseline assessments will be conducted using the same instruments. Post-test assessments will be performed 4 weeks later.

After study completion, control group participants who wish will be offered one session of laughter yoga.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The intervention will be conducted by Assist. Prof. Dr. Nurten ÖZÇALKAP. No invasive procedures will be performed; participants will engage in deep breathing, warm-up exercises, playful activities, and laughter exercises. The researcher holds an internationally certified training in laughter therapy.

Intervention Group Participants will be invited face-to-face, informed about the study, and provide consent. They will be assigned to groups of 8 - 9 and receive laughter yoga twice weekly for a total of 8 sessions (20-40 minutes each) in a suitable hospital or institutional setting.

Baseline assessments will include the Introductory Information Form, Brain Fog Scale, Psychological Well-Being Scale, and Sleep Quality Scale. These scales will be re-administered after the 8th session.

Control Group Participants will be recruited similarly and provide consent. Baseline assessments will be conducted using the same instruments. Post-test assessments will be performed 4 weeks later.

After study completion, control group participants who wish will be offered one session of laughter yoga.

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Ağri
      • Ağrı, Ağri, Turkey (Türkiye), 04100
        • Ağri İbrahim Çeçen Universty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Willingness to participate in the study
  • Ability to communicate
  • Having entered menopause within the last 3 years
  • Having experienced natural menopause
  • Being literate

Exclusion Criteria:

  • Having undergone surgical menopause
  • Having a serious psychiatric or neurological disorder (e.g., schizophrenia, bipolar disorder, dementia, epilepsy)
  • Having a chronic disease that may significantly affect overall quality of life and cognitive functions
  • Having a physical condition that prevents participation in laughter therapy sessions (e.g., respiratory distress, vertigo, incontinence, severe cardiac disease)
  • Using antidepressants or engaging in other non-pharmacological methods to reduce stress
  • Receiving hormone replacement therapy
  • Having experienced a traumatic event within the past year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: Group 1 laughter yoga therapy
Participants received a total of 8 sessions of laughter yoga therapy, conducted twice weekly.
Other: grup 1 laughter yoga therapy
Participants received a total of 8 sessions of laughter yoga therapy, conducted twice weekly.
No Intervention: Group 2 Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Introductory Information Form:
Time Frame: Baseline
This form was developed by the researchers based on the literature and includes questions on participants' sociodemographic characteristics.
Baseline
Brain Fog Scale
Time Frame: Baseline, After 4 weeks
This scale consists of 30 items and three subdimensions. The total score ranges from 30 to 150. The cognitive symptoms subscale ranges from 17 to 85, the physical symptoms subscale from 8 to 40, and the psychological symptoms subscale from 5 to 25. Higher scores on the total scale and/or subscales indicate greater levels of brain fog.
Baseline, After 4 weeks
Psychological Well-Being Scale
Time Frame: Baseline, After 4 weeks
Developed by Diener et al. and adapted into Turkish by Telef, this scale consists of eight items. The items assess components such as individuals' sense of competence, quality of relationships, and life evaluation. The scale contains no reverse-scored items and uses a 7-point Likert format ranging from 1 (strongly agree) to 7 (strongly disagree). The total score ranges from 8 to 56, with higher scores indicating higher psychological well-being. Six items assess core dimensions of well-being, while two items contribute to score balance. The Cronbach's alpha coefficient of the scale was reported as 0.87.
Baseline, After 4 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline, After 4 weeks
The PSQI was developed in 1989, and its validity and reliability in Türkiye were established in 1996. It assesses sleep quality and disturbances over a one-month period. The index includes 24 items; however, item 19 and the last five items are used for clinical information only and are not included in scoring. The remaining 18 self-reported items evaluate seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each component is scored between 0 and 3, and the sum of these yields a global PSQI score ranging from 0 to 21. A total score above 5 indicates poor sleep quality, while a score of 5 or below indicates good sleep quality. The Cronbach's alpha coefficient of the scale was reported as 0.80.
Baseline, After 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Agri Ibrahim Cecen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Actual)

March 1, 2025

Study Completion (Actual)

June 30, 2025

Study Registration Dates

First Submitted

April 4, 2026

First Submitted That Met QC Criteria

April 4, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 18, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/13
  • Laughter Therapy (Other Identifier: 2024/13)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared due to ethical considerations and the need to protect participant confidentiality. The data contain sensitive personal information, and participants did not provide consent for public data sharing. However, anonymized data may be made available upon reasonable request to the corresponding author.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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