Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-31 @ 8:21 PM
Study NCT ID:
NCT07097558
Status:
RECRUITING
Last Update Posted:
2025-08-17
First Post:
2025-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mandala and Music for PMS Relief
Sponsor:
Istanbul University - Cerrahpasa
Organization:
Study Overview
Official Title:
The Effect of Mandala Coloring and Music Listening on Premenstrual Syndrome Symptoms and Quality of Life: A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
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 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: