Mandala and Music for PMS Relief

Istanbul University - Cerrahpasa

Status: Enrolling

Conditions: Music Listening; Mandala Coloring; Premenstrual Syndrome-PMS

Treatments: Other: Mandala coloring group; Other: Music listening group; Other: control group

Study type: Interventional

Funder types: Other

Identifiers

NCT07097558

IstanbulUC-EBE-RD-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.
• Must have the Zoom program installed and ready to use on their electronic device (phone or computer).

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups

Mandala coloring group

Experimental group

Description:

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

Treatment:

Other: Mandala coloring group

Music listening group

Experimental group

Description:

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

Treatment:

Other: Music listening group

Control group

Experimental group

Description:

The control group will not receive any intervention.

Treatment:

Other: control group