The Effect of Mandala Coloring and Music Listening on Premenstrual Syndrome Symptoms and Quality of Life: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 108
- Locations
- 1
- Primary Endpoint
- The Effect of Mandala Coloring on Premenstrual Syndrome Symptoms
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts 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.
Arms & Interventions
Mandala coloring group
The mandala painting intervention will be administered twice a week for 8 weeks for the mandala painting group.
Intervention: Mandala coloring group (Other)
Control group
The control group will not receive any intervention.
Intervention: control group (Other)
Music listening group
The music listening group will listen to classical music twice a week for 8 weeks for 30 minutes, twice a day.
Intervention: Music listening group (Other)
Outcomes
Primary Outcomes
The Effect of Mandala Coloring on Premenstrual Syndrome Symptoms
Time Frame: eight weeks
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.
The Effect of MMusic Listening on Premenstrual Syndrome Symptoms
Time Frame: eight weeks
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.
The Effect of Mandala Coloring on Premenstrual Syndrome Symptoms
Time Frame: eight weeks
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.
The Effect of MMusic Listening on Premenstrual Syndrome Symptoms
Time Frame: eight weeks
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.
Secondary Outcomes
- The Effect of Mandala Coloring Quality of Life(eight weeks)
- The Effect of Music Listening on Quality of Life(eight weeks)
- The Effect of Music Listening on Quality of Life(eight weeks)
- The Effect of Mandala Coloring Quality of Life(eight weeks)
Investigators
Rukiye Duman
RESEARCH ASSISTANT
Istanbul University - Cerrahpasa