Investigation of The Effect of Video-Assisted Laughter Yoga

March 31, 2026 updated by: Safiye AĞAPINAR ŞAHİN, Ataturk University

Investigation of The Effect of Video-Assisted Laughter Yoga on Pain and Menstrual Symptoms in Primary Dysmenorrhea

This study is planned to examine the effect of video-assisted laughter yoga on pain and menstrual symptoms among students studying at a university in Türkiye. Data will be collected at the Faculty of Health Sciences, Konya Karatay University, between November 2025 and April 2026. The study population will consist of students aged 18 to 24 years studying at the Faculty of Health Sciences during the specified period. The sample size was calculated using the G Power computer program. Using a power analysis at the α=0.05 level, the effect size was calculated as 150, 153 (d=0.8), and the working power was calculated as 90%, indicating that at least 68 students should be included in the sample. Students meeting the research criteria and agreeing to participate in the study will be randomly assigned to an experimental group and a control group. The socio-demographic data of the students in the Faculty of Health Sciences, the Visual Analog Scale to assess students' pain, and the Menstrual Symptom Scale to measure menstrual symptoms, prepared by the researcher in accordance with the literature, will be used.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Research data will be collected face-to-face by the researcher. The study will be conducted with students who meet the inclusion criteria (being a student in the Faculty of Health Sciences, being willing to participate in the research, and being open to communication and collaboration). Pre-test assessment tools will be administered to the participating students. Following this, Laughter Yoga practice will be conducted. A total of 24 sessions will be implemented. Final post-test data will be administered after the last session.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Safiye Ağapınar Şahin, Assoc. Prof.
  • Phone Number: 04422311233
  • Email: pinarsaf@gmail.com

Study Contact Backup

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Students with regular menstrual periods (lasting 3-8 days, with a menstrual cycle range of 21-35 days)
  • Students with dysmenorrhea pain intensity of 45 mm or more according to the Visual Analog Scale (VAS).

Exclusion Criteria:

  • Students diagnosed with secondary dysmenorrhea (endometriosis, ovarian cyst/tumor, pelvic infectious disease, myoma, uterine polyps, uterine adhesions, infection, etc.),
  • those using oral contraceptives,
  • those with compromised tissue integrity in the abdominal area,
  • those with any chronic or mental illness.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Session I
The session will begin with hand clapping and warm-up exercises, followed by deep breathing exercises, childlike acting, and laughter exercises.
Behavioral: Session 1: Laughter Yoga
Each session includes hand clapping and warm-up exercises, deep breathing techniques, childlike playfulness activities, structured laughter exercises, and a brief relaxation phase.
Experimental: Session II
The session will begin with hand clapping and warm-up exercises, followed by deep breathing exercises, childlike acting, and laughter exercises.
Behavioral: Session 2: Laughter Yoga
Each session includes hand clapping and warm-up exercises, deep breathing techniques, childlike playfulness activities, structured laughter exercises, and a brief relaxation phase.
Experimental: Session III
The session will begin with hand clapping and warm-up exercises, followed by deep breathing exercises, childlike acting, and laughter exercises.
Behavioral: Session 3: Laughter Yoga
Each session includes hand clapping and warm-up exercises, deep breathing techniques, childlike playfulness activities, structured laughter exercises, and a brief relaxation phase.
Experimental: Session IV
The session will begin with hand clapping and warm-up exercises, followed by deep breathing exercises, childlike acting, and laughter exercises.
Behavioral: Session 4: Laughter Yoga
Each session includes hand clapping and warm-up exercises, deep breathing techniques, childlike playfulness activities, structured laughter exercises, and a brief relaxation phase.
Experimental: Session V
The session will begin with hand clapping and warm-up exercises, followed by deep breathing exercises, childlike acting, and laughter exercises.
Behavioral: Session 5: Laughter Yoga
Each session includes hand clapping and warm-up exercises, deep breathing techniques, childlike playfulness activities, structured laughter exercises, and a brief relaxation phase.
Experimental: Session VI
The session will begin with hand clapping and warm-up exercises, followed by deep breathing exercises, childlike acting, and laughter exercises.
Behavioral: Session 6: Laughter Yoga
Each session includes hand clapping and warm-up exercises, deep breathing techniques, childlike playfulness activities, structured laughter exercises, and a brief relaxation phase.
Experimental: Session VII
The session will begin with hand clapping and warm-up exercises, followed by deep breathing exercises, childlike acting, and laughter exercises.
Behavioral: Session 7: Laughter Yoga
Each session includes hand clapping and warm-up exercises, deep breathing techniques, childlike playfulness activities, structured laughter exercises, and a brief relaxation phase.
Experimental: Session VIII
The session will begin with hand clapping and warm-up exercises, followed by deep breathing exercises, childlike acting, and laughter exercises.
Behavioral: Session 8: Laughter Yoga
Each session includes hand clapping and warm-up exercises, deep breathing techniques, childlike playfulness activities, structured laughter exercises, and a brief relaxation phase.
Experimental: Session IX
The session will begin with hand clapping and warm-up exercises, followed by deep breathing exercises, childlike acting, and laughter exercises.
Behavioral: Session 9: Laughter Yoga
Each session includes hand clapping and warm-up exercises, deep breathing techniques, childlike playfulness activities, structured laughter exercises, and a brief relaxation phase.
Experimental: Session X
The session will begin with hand clapping and warm-up exercises, followed by deep breathing exercises, childlike acting, and laughter exercises.
Behavioral: Session 10: Laughter Yoga
Each session includes hand clapping and warm-up exercises, deep breathing techniques, childlike playfulness activities, structured laughter exercises, and a brief relaxation phase.
Experimental: Session XI
The session will begin with hand clapping and warm-up exercises, followed by deep breathing exercises, childlike acting, and laughter exercises.
Behavioral: Session 11: Laughter Yoga
Each session includes hand clapping and warm-up exercises, deep breathing techniques, childlike playfulness activities, structured laughter exercises, and a brief relaxation phase.
Experimental: Session XII
The session will begin with hand clapping and warm-up exercises, followed by deep breathing exercises, childlike acting, and laughter exercises.
Behavioral: Session 12: Laughter Yoga
Each session includes hand clapping and warm-up exercises, deep breathing techniques, childlike playfulness activities, structured laughter exercises, and a brief relaxation phase.
Experimental: Session XIII
The session will begin with hand clapping and warm-up exercises, followed by deep breathing exercises, childlike acting, and laughter exercises.
Behavioral: Session 13: Laughter Yoga
Each session includes hand clapping and warm-up exercises, deep breathing techniques, childlike playfulness activities, structured laughter exercises, and a brief relaxation phase.
Experimental: Session XIV
The session will begin with hand clapping and warm-up exercises, followed by deep breathing exercises, childlike acting, and laughter exercises.
Behavioral: Session 14: Laughter Yoga
Each session includes hand clapping and warm-up exercises, deep breathing techniques, childlike playfulness activities, structured laughter exercises, and a brief relaxation phase.
Experimental: Session XV
The session will begin with hand clapping and warm-up exercises, followed by deep breathing exercises, childlike acting, and laughter exercises.
Behavioral: Session 15: Laughter Yoga
Each session includes hand clapping and warm-up exercises, deep breathing techniques, childlike playfulness activities, structured laughter exercises, and a brief relaxation phase.
Experimental: Session XVI
The session will begin with hand clapping and warm-up exercises, followed by deep breathing exercises, childlike acting, and laughter exercises.
Behavioral: Session 16: Laughter Yoga
Each session includes hand clapping and warm-up exercises, deep breathing techniques, childlike playfulness activities, structured laughter exercises, and a brief relaxation phase.
Experimental: Session XVII
The session will begin with hand clapping and warm-up exercises, followed by deep breathing exercises, childlike acting, and laughter exercises.
Behavioral: Session 17: Laughter Yoga
Each session includes hand clapping and warm-up exercises, deep breathing techniques, childlike playfulness activities, structured laughter exercises, and a brief relaxation phase.
Experimental: Session XVIII
The session will begin with hand clapping and warm-up exercises, followed by deep breathing exercises, childlike acting, and laughter exercises.
Behavioral: Session 18: Laughter Yoga
Each session includes hand clapping and warm-up exercises, deep breathing techniques, childlike playfulness activities, structured laughter exercises, and a brief relaxation phase.
Experimental: Session XIX
The session will begin with hand clapping and warm-up exercises, followed by deep breathing exercises, childlike acting, and laughter exercises.
Behavioral: Session 19: Laughter Yoga
Each session includes hand clapping and warm-up exercises, deep breathing techniques, childlike playfulness activities, structured laughter exercises, and a brief relaxation phase.
Experimental: XX
The session will begin with hand clapping and warm-up exercises, followed by deep breathing exercises, childlike acting, and laughter exercises.
Behavioral: Session 20: Laughter Yoga
Each session includes hand clapping and warm-up exercises, deep breathing techniques, childlike playfulness activities, structured laughter exercises, and a brief relaxation phase.
Experimental: Session XXI
The session will begin with hand clapping and warm-up exercises, followed by deep breathing exercises, childlike acting, and laughter exercises.
Behavioral: Session 21: Laughter Yoga
Each session includes hand clapping and warm-up exercises, deep breathing techniques, childlike playfulness activities, structured laughter exercises, and a brief relaxation phase.
Experimental: XXII
The session will begin with hand clapping and warm-up exercises, followed by deep breathing exercises, childlike acting, and laughter exercises.
Behavioral: Session 22: Laughter Yoga
Each session includes hand clapping and warm-up exercises, deep breathing techniques, childlike playfulness activities, structured laughter exercises, and a brief relaxation phase.
Experimental: XXIII
The session will begin with hand clapping and warm-up exercises, followed by deep breathing exercises, childlike acting, and laughter exercises.
Behavioral: Session 23: Laughter Yoga
Each session includes hand clapping and warm-up exercises, deep breathing techniques, childlike playfulness activities, structured laughter exercises, and a brief relaxation phase.
Experimental: XXIV
The session will begin with hand clapping and warm-up exercises, followed by deep breathing exercises, childlike acting, and laughter exercises.
Behavioral: Session 24: Laughter Yoga
Each session includes hand clapping and warm-up exercises, deep breathing techniques, childlike playfulness activities, structured laughter exercises, and a brief relaxation phase.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Demographic Information Form
Time Frame: up to 1 day
This form consists of 14 questions prepared by the researcher. It includes questions about students' demographic information (age, department, class, marital status, and place of residence) and characteristics of their menstrual cycle (age of menarche, duration of bleeding and pain, etc.).
up to 1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS)
Time Frame: up to 1 day
VAS is used to measure the pain a person perceives. On a 10 cm (100 mm) section of the scale, one end is marked with no pain (zero), and the other end with the most severe pain possible (10). The individual can indicate their pain by drawing a line, placing a dot, or marking a point. The distance from the point where there is no pain to the point marked by the individual is measured in centimeters, and the resulting value indicates the severity of the individual's pain. On the VAS scale, 0-44 mm indicates mild pain, 45-74 mm indicates moderate pain, and 75-100 mm indicates severe pain.
up to 1 day

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Menstrual Symptom Scale (MSS)
Time Frame: up to 1 day
Developed in 1975 by Chesney and Tasto to assess menstrual pain and symptoms, it was updated in 2009 by Negriff et al., who re-evaluated its factor structure and usability in adolescents. Turkish validity and reliability were established by Güvenç et al. in 2014. The MSS is a five-point Likert-type scale consisting of twenty-two items. Participants are asked to rate their menstrual symptoms on a scale of 1 (never) to 5 (always). The scale has three sub-dimensions: 'Negative Effects/Somatic Complaints' (Items 1-13), 'Menstrual Pain Symptoms' (Items 14-19), and 'Coping Mechanisms' (Items 20-22). The highest possible score is 110, and the lowest is 22. The MSÖ score is calculated by taking the average of the total scores of the items on the scale. A higher average score indicates increased severity of menstrual symptoms. The score obtained from the subdimensions is calculated by taking the average of the total scores of the items in the subdimensions. A
up to 1 day

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ataturk University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
KTO Karatay University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 30, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 3, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 22, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 7, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SSAHIN0003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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Drug Interventions

Conditions

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