Mandala and Music for PMS Relief

NCT07097558 | Recruiting

• 1 other identifier: IstanbulUC-EBE-RD-01
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Mandala Coloring; Music Listening; Premenstrual Syndrome-PMS

Keywords

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

Outcome Measures

Primary Outcomes (2)

• The Effect of Mandala Coloring on Premenstrual Syndrome Symptoms

  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.

  eight weeks

• The Effect of MMusic Listening on Premenstrual Syndrome Symptoms

  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.

  eight weeks

Secondary Outcomes (2)

• The Effect of Mandala Coloring Quality of Life

  eight weeks

• The Effect of Music Listening on Quality of Life

  eight weeks

Study Arms (3)

Mandala coloring group

EXPERIMENTAL

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

Other: Mandala coloring group

Music listening group

EXPERIMENTAL

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

Other: Music listening group

Control group

EXPERIMENTAL

The control group will not receive any intervention.

Other: control group

Interventions

Mandala coloring group OTHER

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

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.

Music listening group

control group OTHER

The control group will not receive any intervention.

Control group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Rukiye Duman: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Istanbul University- Cerrahpasa

Istanbul, AVCILAR, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• RUKIYE DUMAN, RESEARCH ASSISTANT

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

RUKIYE DUMAN, RESEARCH ASSISTANT

CONTACT

+90 5530315895; rukiye.duman@iuc.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: RESEARCH ASSISTANT

Model Details: 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."

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: July 31, 2025
• Study Start: August 13, 2025
• Primary Completion: March 31, 2026
• Study Completion: May 1, 2026
• Last Updated: March 18, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)