Clinical trial NCT06314165: Evaluation of the Effect of Music Medicine Application on Menstrual Symptoms
Official title: Evaluation of the Effect of Music Medicine Application on Menstrual Symptoms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Menstruation; Syndrome
Keywords: music medicine
menstruation symptom
menstrual pain
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 62
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups: comparative experiment and control
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: menstruation symptom scale
timeFrame: Two months
Secondary outcomes:
measure: Visual Analogue Scale
timeFrame: Two months
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University Faculty of Health Sciences
Study officials:
affiliation: Pamukkale University
name: Sevgi Özkan Professor Doctor
role: PRINCIPAL_INVESTIGATOR
References: