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Completed

NCT Number: NCT07097558

Mandala and Music for PMS Relief

Purpose: The aim of this project is to examine the effects of mandala painting and music performance interventions on premenstrual syndrome symptoms and quality of life.

The hypotheses of the study are as follows:

Coloring mandalas has a positive effect on premenstrual syndrome symptoms. Listening to music has a positive effect on premenstrual syndrome symptoms. Listening to music has a positive effect on quality of life. Coloring mandalas has a positive effect on quality of life.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University- Cerrahpasa

Istanbul, AVCILAR, Turkey (Türkiye)

About this study

Objective: The aim of this project is to examine the effects of mandala coloring and music performance interventions on premenstrual syndrome symptoms and quality of life.

The study aims to reach all students experiencing premenstrual syndrome symptoms without resorting to sample size calculations. Therefore, since a high effect size is expected in the study, Cohen's standard effect size of 0.25, which is between moderate and large, was accepted. Therefore (α = 0.05, effect size = 0.25, 1-β = 0.80), the minimum sample size was calculated as 108 participants (n = 36 for each group).

The study includes a mandala coloring group, a music performance group, and a control group. The mandala coloring intervention will be applied twice a week for 8 weeks, and the music performance will be applied twice a day for 30 minutes for 8 weeks. Participants in the music performance group will listen to classical music. The control group will not receive any intervention. The Demographic Information Form, the Premenstrual Syndrome Scale (PMSS), and the WHOQOL-BREF-TR Quality of Life Scale will be used as data collection tools. The first measurement will be administered before the interventions. The second measurement will be collected in the fourth week after the intervention, and the third measurement in the eighth week. The data obtained in the study will be entered into a database using IBM SPSS 25.0 (Statistical Package for Social Sciences), and all necessary statistical analyses will be performed in the same program.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be an undergraduate student studying midwifery at Istanbul University-Cerrahpaşa Faculty of Health Sciences.
  • Must have a score of 110 or higher on the PMSS.
  • Must have an internet connection.

Exclusion criteria

  • Must be under 18 years of age.
  • Must have a change in menstrual cycle characteristics after being diagnosed with PMS.

Treatment and study plan

Mandala coloring group

Other

The mandala painting intervention will be administered twice a week for 8 weeks for the mandala coloring group.

Music Listening Group

Other

The music listening group will listen to classical music twice a week for 8 weeks for 30 minutes, twice a day.

Control Group

Other

The control group will not receive any intervention.

Primary outcomes

  1. The Effect of Mandala Coloring on Premenstrual Syndrome Symptoms

    Time frame: eight weeks

    Premenstrual Syndrome Scale (PMSS): Developed by Gençdoğan in 2006, this five-point Likert-type scale measures the severity of premenstrual problems, consisting of 44 items and nine subscales. The lowest possible score is 44, and the highest is 220. A higher score indicates a greater severity of PMS problems.

  2. The Effect of MMusic Listening on Premenstrual Syndrome Symptoms

    Time frame: eight weeks

    Premenstrual Syndrome Scale (PMSS): Developed by Gençdoğan in 2006, this five-point Likert-type scale measures the severity of premenstrual problems, consisting of 44 items and nine subscales. The lowest possible score is 44, and the highest is 220. A higher score indicates a greater severity of PMS problems.

Secondary outcomes

  1. The Effect of Mandala Coloring Quality of Life

    Time frame: eight weeks

    WHOQOL-BREF-TR Quality of Life Scale: The Turkish version of the scale has been shown to be valid and reliable. The scale includes subdomains of physical health, psychological health, social relationships, and environment and culture-standardized environmental assessment. Each domain is scored between 4 and 20, with higher scores indicating higher quality of life in that area.

  2. The Effect of Music Listening on Quality of Life

    Time frame: eight weeks

    WHOQOL-BREF-TR Quality of Life Scale: The Turkish version of the scale has been shown to be valid and reliable. The scale includes subdomains of physical health, psychological health, social relationships, and environment and culture-standardized environmental assessment. Each domain is scored between 4 and 20, with higher scores indicating higher quality of life in that area.

Sponsors and collaborators

Lead sponsor

Rukiye Duman

Other

Collaborators

  • The Scientific and Technological Research Council of Turkey

Registry information

Official study title

The Effect of Mandala Coloring and Music Listening on Premenstrual Syndrome Symptoms and Quality of Life: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 31, 2025
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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