Evaluation of the Effect of Music Medicine Application on Menstrual Symptoms

In this study, the "Music Medicine Application" method was chosen in line with the literature and guidelines and it is aimed to determine whether it is effective in reducing the symptoms experienced by female students with "Music Medicine Application" during the menstrual period.

Study Overview

• Status: Recruiting
• Conditions: Menstruation; Syndrome
• Intervention / Treatment: Other: music medicine practice

Detailed Description

This study aims to determine whether the application of music medicine is effective in reducing the symptoms experienced by female students during the menstrual period. The type of research was planned as a prospective, randomized controlled experimental study with a pretest-posttest control group. The research will be conducted with female students studying at Pamukkale University Faculty of Health Sciences. The data of the research will be collected between March 2024 and February 2025. Personal Information Form, Visual Analogue Scale and Menstruation Symptom Scale will be used to collect data. It was determined that a total of 62 people should participate in the research, 31 in the experimental group and 31 in the control group. As the randomization method, "simple randomization" will be used to ensure an equal number of samples in the experimental and control groups. Randomization will be done using the www.randomizer.org application. The data will be analyzed using the SPSS (23.0) package program. Continuous variables will be given as mean ± standard deviation and categorical variables will be given as number and percentage. Significance Test of Difference Between Two Means in comparing independent group differences when parametric test assumptions are met; When parametric test assumptions are not met, Mann-Whitney U test will be used to compare independent group differences.

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rabia Nur Doğan; Phone Number: +905528400797; Email: rabianur_1997@hotmail.com
• Study Contact Backup: Name: Sevgi Özkan Professor Doctor; Phone Number: +905336125588; Email: sozkan@pau.edu.tr

Study Locations

• Turkey
  • Denizli, Turkey, 20180
    • Recruiting
    • Pamukkale University Faculty of Health Sciences
    • Contact: Rabia Nur Doğan; Phone Number: +905528400797; Email: rabianur_1997@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Volunteering to participate in the research
2. Menstrual cycle length has been within normal limits (21-35) for the last 3 months
3. Not using oral contraceptives for the last 3 months
4. Not having any psychiatric problems and not receiving any treatment for this in the last 3 months.
5. Not using painkillers or any pharmacological agents or methods that reduce symptoms during the study.
6. Participants who marked 1.1-10 according to Visüel analog scala

Exclusion Criteria:

1. Presence of chronic diseases or serious medical conditions
2. Presence of another physical or psychological disorder that may affect menstrual symptoms
3. Presence of psychiatric or psychological disorders
4. Active drug use or hormone therapy
5. Having given birth
6. Answering survey questions incompletely or not answering them
7. Participants who marked 0-1 according to Visüel analog scala
8. Not applying music medicine for the experimental group

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group practicing music medicine; There will be 2 follow-ups for each group. In the first follow-up for the experimental group, when symptoms begin on the first day of their menstrual period, they will be asked to fill out the Menstruation Symptom Scale and Visual Analogue Scale, and the designated music will be played for 30 minutes. After 30 minutes, he/she will be asked to fill out the same surveys again. In the 2nd follow-up (during the menstrual period one month after the first follow-up), they will be asked to repeat what was done in the 1st follow-up on the first day of their menstrual period.	Other: music medicine practice; Music medicine will be applied
No Intervention: Group where music medicine is not applied; Two follow-ups will be applied to the groups. At the first follow-up for the control group, they will be asked to fill out the Menstruation Symptom Scale and Visual Analog Scale when symptoms begin on the first day of their menstrual period. In the 2nd follow-up (during the menstrual period one month after the first follow-up), they will be asked to repeat what was done in the 1st follow-up on the first day of their menstrual period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
menstruation symptom scale	Participants are asked to rate the symptoms they experience regarding menstruation between 1 (never) and 5 (always). Scale items are numbered according to certain factors for ease of use. Items 1-13 belong to the "Negative effects/somatic complaints" subcategory, items 14-19 belong to the "Menstrual pain symptoms" subcategory, and items 20-22 belong to the "Coping methods" subcategory. A five-point Likert type was used in the Menstruation Symptom Scale, which consists of 22 items. The score obtained from the sub-dimensions is calculated by taking the total score average of the items in the relevant sub-dimension. An increase in the mean score for sub-dimensions indicates that the severity of menstrual symptoms in that sub-dimension has increased.	Two months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale	Participants were included in the "healthy" category when they marked the 0-1 range of the scale, and were included in the "Menstruation pain" category when they marked the 1.1-10 range. They were divided into 3 groups according to pain severity. 1.1-3: Mild pain, 3.1-7: Moderate pain, 7.1-10: Severe pain.	Two months

Collaborators and Investigators

• Sponsor: Pamukkale University
• Investigators: Principal Investigator: Sevgi Özkan Professor Doctor, Pamukkale University

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: March 10, 2024
• First Submitted That Met QC Criteria: March 10, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: menstrual pain; music medicine; menstruation symptom
• Additional Relevant MeSH Terms: Pathologic Processes; Menstruation Disturbances
• Other Study ID Numbers: PamukkaleU-SBE-RND-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No