The Effect of Laughter Yoga on Premenstrual Syndrome Symptoms and Quality of Life in Young Women

NCT07139223 | Completed DMC

• 1 other identifier: LokmanHekimU-KDH-GA-01
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

Premenstrual syndrome (PMS) is a common condition among young women, characterized by physical, emotional, and behavioral symptoms that negatively affect quality of life. Laughter yoga, a non-pharmacological mind-body intervention combining breathing techniques, relaxation, and intentional laughter, has been shown to reduce stress, improve mood, and enhance well-being. This randomized controlled trial aims to evaluate the effect of laughter yoga on PMS symptoms and quality of life in young women.

Conditions

Premenstrual Syndrome-PMS

Keywords

Premenstrual Syndrome; Laughter Yoga; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Premenstrual Syndrome Symptom Severity

  The Premenstrual Syndrome Scale (PMS) will be used to assess participants. Participants will first take a pre-intervention pretest. They will then complete a total of eight laughter yoga sessions twice a week for four weeks. Interim measurements will be taken after the laughter yoga sessions are completed. Participants will be assigned homework assignments to practice laughter practices daily for four weeks. Following the homework assignments, a post-test will be administered to assess changes in PMS symptom severity.

  8 week

Study Arms (2)

intervention arm

EXPERIMENTAL

Intervention arm: Laughter yoga group sessions will be implemented twice a week for 4 weeks (8 sessions in total); the first session will be \~45 min, the subsequent sessions \~30 min. Sessions will be conducted face-to-face in a suitable room within the institution. Following the interim measurement in week 4, the intervention arm will continue structured individual laughter practices daily for 4 weeks.

Behavioral: laughter yoga

control arm

NO INTERVENTION

No intervention will be applied to the control arm; after the post-tests, the same training will be offered to this group for ethical reasons (delayed intervention).

Interventions

laughter yoga BEHAVIORAL

Intervention arm: Laughter yoga group sessions will be implemented twice a week for 4 weeks (8 sessions in total); the first session will be \~45 min, the subsequent sessions \~30 min. Sessions will be conducted face-to-face in a suitable room within the institution. Following the interim measurement in week 4, the intervention arm will continue structured individual laughter practices daily for 4 weeks.

intervention arm

Eligibility Criteria

• Age: 18 Years - 25 Years
• Gender Eligibility Details: The reason why only female participants were included in the study is that premenstrual syndrome is a syndrome that occurs only in women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Experiencing premenstrual symptoms (PMS score of 110 or higher),
• Are between the ages of 18-25,
• Have regular menstrual periods,
• Can read and understand Turkish,

You may not qualify if:

• Students who completed the pretest data collection forms incompletely,
• Students who were taking medication due to a chronic illness,
• Students who were using hormonal contraceptive methods,
• Students who had any health problems that could create a communication barrier,
• Students who were receiving medication for insomnia (such as SSRIs and SNRIs),
• Students who were receiving treatment for PMS,
• Students who were pregnant or lactating in the last 12 months,
• Students who exercised regularly (affecting homogeneity between groups and intervention effectiveness),
• Students who had a diagnosed psychiatric illness (depression, panic attacks, schizophrenia, etc.),
• Students who had a condition that prevented them from practicing laughter yoga (abdominal surgery within the last three months, uncontrolled hypertension, glaucoma, hernia, epilepsy).

Sponsors & Collaborators

• Lokman Hekim University: lead

Study Sites (1)

Bilecik Seyh Edebali University

Bilecik, Bir Eyalet Seçin, 11000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics

Study Officials

• Didem ŞİMŞEK KÜÇÜKKELEPÇE

  Lokman Hekim University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, participants and intervention providers cannot be blinded. However, the statistician performing the data analysis will remain blinded to group allocation. Data will be coded, and the statistician will analyze the outcomes without knowledge of whether participants belong to the intervention or control group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: This study is a two-arm, randomized, parallel-group controlled trial with a 1:1 allocation ratio. Eligible participants will be randomly assigned to either the intervention group (laughter yoga sessions twice a week for 4 weeks, followed by 4 weeks of structured daily individual laughter practices) or the control group (no intervention during the study period). Assessments will be conducted at baseline, after the 4-week group sessions, and after the 8-week follow-up. The primary outcome is the change in PMS symptom severity, and the secondary outcome is the change in quality of life. Due to the nature of the intervention, participants and providers cannot be blinded; however, data will be coded and analyzed by a statistician blinded to group allocation

Study Record Dates

• First Submitted: August 17, 2025
• First Posted: August 24, 2025
• Study Start: October 15, 2025
• Primary Completion: November 15, 2025
• Study Completion: December 15, 2025
• Last Updated: January 8, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)