Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2025-08-13
2026-05-01
Brief Summary
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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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Detailed Description
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The study aims to reach all students experiencing PMS symptoms without resorting to sample calculations. Therefore, because a high effect size is expected in the study, a Cohen's standard effect size of 0.70, which is between medium and large, was assumed. Therefore (α = 0.05, effect size = 0.70, 1-β = 0.80), the minimum sample size was calculated as 120 participants (n = 40 for each group).
The study included a mandala painting group, a music performance group, and a control group. The mandala painting intervention will be administered twice a week for 8 weeks, 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. At the beginning of the study, data will be collected using a Personal Information Form, the Premenstrual Syndrome Scale (PMSS), and the WHOQOL-BREF-TR Quality of Life Scale. Data obtained in the study will be entered into a database using IBM SPSS 25.0 (Statistical Package for the Social Sciences), and all necessary statistical analyses will be conducted in the same program.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Mandala coloring group
The mandala painting intervention will be administered twice a week for 8 weeks for the mandala painting group.
Mandala coloring group
The mandala painting intervention will be administered twice a week for 8 weeks for the mandala coloring group.
Music listening group
The music listening group will listen to classical music twice a week for 8 weeks for 30 minutes, twice a day.
Music listening group
The music listening group will listen to classical music twice a week for 8 weeks for 30 minutes, twice a day.
Control group
The control group will not receive any intervention.
control group
The control group will not receive any intervention.
Interventions
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Mandala coloring group
The mandala painting intervention will be administered twice a week for 8 weeks for the mandala coloring group.
Music listening group
The music listening group will listen to classical music twice a week for 8 weeks for 30 minutes, twice a day.
control group
The control group will not receive any intervention.
Eligibility Criteria
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Inclusion Criteria
* Must have a score of 110 or higher on the PMSS.
* Must have an internet connection.
* Must have the Zoom program installed and ready to use on their electronic device (phone or computer).
Exclusion Criteria
* Must have a change in menstrual cycle characteristics after being diagnosed with PMS.
18 Years
FEMALE
Yes
Sponsors
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The Scientific and Technological Research Council of Turkey
OTHER
Istanbul University - Cerrahpasa
OTHER
Responsible Party
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Rukiye Duman
RESEARCH ASSISTANT
Principal Investigators
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RUKIYE DUMAN, RESEARCH ASSISTANT
Role: PRINCIPAL_INVESTIGATOR
Istanbul University - Cerrahpasa
Locations
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Istanbul University- Cerrahpasa
Istanbul, AVCILAR, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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ISTANBUL UNIVERSITY- CERRAHPASA
Role: primary
Other Identifiers
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IstanbulUC-EBE-RD-01
Identifier Type: -
Identifier Source: org_study_id
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