- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07514546
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
Recruiting
Conditions
Intervention / Treatment
- Behavioral: Session 1: Laughter Yoga
- Behavioral: Session 2: Laughter Yoga
- Behavioral: Session 3: Laughter Yoga
- Behavioral: Session 4: Laughter Yoga
- Behavioral: Session 5: Laughter Yoga
- Behavioral: Session 6: Laughter Yoga
- Behavioral: Session 7: Laughter Yoga
- Behavioral: Session 8: Laughter Yoga
- Behavioral: Session 9: Laughter Yoga
- Behavioral: Session 10: Laughter Yoga
- Behavioral: Session 11: Laughter Yoga
- Behavioral: Session 12: Laughter Yoga
- Behavioral: Session 13: Laughter Yoga
- Behavioral: Session 14: Laughter Yoga
- Behavioral: Session 15: Laughter Yoga
- Behavioral: Session 16: Laughter Yoga
- Behavioral: Session 17: Laughter Yoga
- Behavioral: Session 18: Laughter Yoga
- Behavioral: Session 19: Laughter Yoga
- Behavioral: Session 20: Laughter Yoga
- Behavioral: Session 21: Laughter Yoga
- Behavioral: Session 22: Laughter Yoga
- Behavioral: Session 23: Laughter Yoga
- Behavioral: Session 24: Laughter Yoga
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
Interventional
Enrollment (Estimated)
68
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 Contact
- Name: Safiye Ağapınar Şahin, Assoc. Prof.
- Phone Number: 04422311233
- Email: pinarsaf@gmail.com
Study Contact Backup
- Name: Hediye Karakoç, Assoc. Prof.
- Phone Number: 0 541 229 17 26
- Email: hediye.bekmezci@karatay.edu.tr
Study Locations
-
-
Karatay
-
Konya, Karatay, Turkey (Türkiye)
- Recruiting
- KTO Karatay Üniversitesi
-
Contact:
- Safiye Ağapınar Şahin
- Phone Number: 0 442 231 12 33
- Email: pinarsaf@gmail.com
-
Contact:
- Hediye Karakoç
- Phone Number: 0 541 229 1726
- Email: hediye.bekmezci@karatay.edu.tr
-
-
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
- 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 |
Intervention / Treatment |
|---|---|
|
Experimental: Session I
The session will begin with hand clapping and warm-up exercises, followed by deep breathing exercises, childlike acting, and laughter exercises.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
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
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
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
Collaborators
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 30, 2024
Primary Completion (Actual)
November 3, 2025
Study Completion (Estimated)
April 22, 2026
Study Registration Dates
First Submitted
March 31, 2026
First Submitted That Met QC Criteria
March 31, 2026
First Posted (Actual)
April 7, 2026
Study Record Updates
Last Update Posted (Actual)
April 7, 2026
Last Update Submitted That Met QC Criteria
March 31, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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