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Mandala and Music for PMS Relief

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07097558
Enrollment
108
Registered
2025-07-31
Start date
2025-08-13
Completion date
2026-05-01
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mandala Coloring, Music Listening, Premenstrual Syndrome-PMS

Keywords

Music Listening, music, art therapy, mandala coloring, Premenstrual Syndrome

Brief summary

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.

Detailed description

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.

Interventions

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

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

OTHERcontrol group

The control group will not receive any intervention.

Sponsors

Rukiye Duman
Lead SponsorOTHER
The Scientific and Technological Research Council of Turkey
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

To determine the groups for university students who meet the sampling criteria for the study's randomization, participants will be assigned to the experimental and control groups using the "Randomizer.org" program. Numbers 1 to 120 will be randomized into three groups using a computer-assisted randomization program (https://www.randomizer.org). Students in the experimental and control groups will be prevented from interacting with each other to avoid being affected by the interventions. Inclusion and exclusion criteria, as well as exclusion from the study during the study, are specified below.

Intervention model description

The study includes a mandala coloring group, a music group, and a control group. Participating students will be informed about the study and provided with an "Informed Consent Form" and a "Voluntary Consent Form." The mandala painting intervention will be administered twice a week for 8 weeks to the mandala painting group, and the music performance will be administered twice a week for 30 minutes, twice a day, for 8 weeks. Participants in the music performance group will listen to classical music. The control group will not receive any intervention. Data will be collected using a "The Demographic Information Form," the "Premenstrual Syndrome Scale (PMSS)," and the "WHOQOL-BREF-TR Quality of Life Scale."

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
The Effect of Mandala Coloring on Premenstrual Syndrome Symptomseight weeksPremenstrual 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.
The Effect of MMusic Listening on Premenstrual Syndrome Symptomseight weeksPremenstrual 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

MeasureTime frameDescription
The Effect of Mandala Coloring Quality of Lifeeight weeksWHOQOL-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.
The Effect of Music Listening on Quality of Lifeeight weeksWHOQOL-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.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORRUKIYE DUMAN, RESEARCH ASSISTANT

Istanbul University - Cerrahpasa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 14, 2026