The Effect of Mindfulness Training on Premenstrual Syndrome Symptoms and Quality of Life

December 13, 2025 updated by: Nisan Akçay

The Effect of Mindfulness-Based Healthy Living Behaviors Training on Premenstrual Syndrome Symptoms and Quality of Life

Premenstrual syndrome (PMS) is an important health problem that negatively affects women's quality of life by reducing their daily activities, sleep quality, cognitive functioning, interpersonal relationships, academic performance, work and school attendance. Studies show that PMS is associated with unhealthy life behaviors and that PMS can be reduced through the development of healthy life behaviors. Midwives can benefit from mindfulness-based programs while providing quality health care services to develop a healthy lifestyle in the prevention and treatment of PMS in women. In the literature, there is no study examining the effectiveness of mindfulness-based healthy life behaviors training on PMS. To the best of our knowledge, our study is the first study to examine the effect of a mindfulness-based healthy life behaviors training program on premenstrual syndrome symptoms and quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

114

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

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:

Regular menstruation Those who score at least 132 or higher on the PMS scale Agreeing to participate in the study With internet access

Exclusion Criteria:

Having a psychiatric diagnosis or gynecological disease Kontraseptif medication use Having a health problem Receiving treatment for PMS

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: Mindfulness
Mindfulness group
Behavioral: mindfulness group
Online training will be implemented 2 times a week for 8 sessions. A 30-45 minute reminder training will be given 1 month after the training. Mindfulness-Based Healthy Living Behaviors Education (MTSYDE) booklet will be sent online to guide students' home practices. Taking into account the possibility of forgetting and demotivation in students, audio recordings will be used, reminder messages will be sent and counseling will be given regarding the program. A post-test will be administered 1 month after the reminder training.
Other: control group
Menstruation-specific Healthy Living Behaviors training of 30-45 minutes in 8 sessions 2 times a week will be provided online. A standard training booklet will be sent 1 month after the training as a reminder. Standard reminder messages will be sent considering the possibility of forgetting and demotivation in students. A post-test will be administered 1 month after the reminder training.
No Intervention: Control
standard training group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Premenstrual Syndrome Scale (PMSS)
Time Frame: Before the start of training and 2 months after the first training
The total score ranges between 44-220. The higher the score, the higher the intensity of premenstrual syndrome symptoms.
Before the start of training and 2 months after the first training
Premenstrual syndrome-specific quality of life scale
Time Frame: Before the training and 2 months after the first training is completed
The total score ranges from 22 to 110, with higher scores indicating better life behaviors.
Before the training and 2 months after the first training is completed
Quality of Life Visual Analog Scale (VAS)
Time Frame: Before the training and 2 months after the first training is completed
Total scale scores range from 0-10. The higher the scale scores, the better the quality of life.
Before the training and 2 months after the first training is completed

Collaborators and Investigators

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

Sponsor

Nisan Akçay

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

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)

May 3, 2025

Primary Completion (Actual)

July 3, 2025

Study Completion (Actual)

August 3, 2025

Study Registration Dates

First Submitted

December 21, 2024

First Submitted That Met QC Criteria

January 2, 2025

First Posted (Actual)

January 3, 2025

Study Record Updates

Last Update Posted (Actual)

December 19, 2025

Last Update Submitted That Met QC Criteria

December 13, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • nisanakçay00001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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