Clinical trial NCT04955912: Music and Premenstrual Symptoms and Quality of Life
Official title: Effects of Music Medicine on Premenstrual Symptoms Levels and Quality of Life: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: MUSIC THERAPY
Premenstrual Syndrome
Keywords: Premenstrual syndrome
music medicine
quality life
midwife
nurse
Lead sponsor: Kırklareli University
Sponsor class: OTHER
First posted: 2021-07-09
Enrollment: 89
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled clinical trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: Premenstrual syndrome is an important health problem affecting women of childbearing age. This study is a prospective, single-blinded randomized controlled trial. Participants were randomized into music, and control groups. Immediately post-intervention, the women in the experimental groups had significantly higher reduce premenstraul syndrome levels and increase a quality life.

Detailed description: Premenstrual syndrome is an important health problem affecting women of childbearing age. This study aimed to show that music medicine can be used to reduce premenstrual syndrome levels and increase quality of life. This study is A prospective, single-blinded randomized controlled trial. The study was conducted between January and April 2021 with 97 women who are college students. Participants consisted of women over 20 years of age and with have premenstraul snydrome. Participants were randomized into music, and control groups. Immediately post-intervention, the women in the experimental groups had a significantly higher reduce premenstraul syndrome levels and increase a quality life. Each method (music and control group) is evaluated for The Premenstrual Syndrome Scale and Short form of the WHOQOL-BREF.

Eligibility criteria: Inclusion Criteria:

* being between the ages of 18 and 30
* being able to speak and understand Turkish,
* having obtained a score of 45 and above from the PMSS,
* having regular menstruation (between 21-35 days),
* completing the scale forms completely and reading and approving the voluntary consent form

Exclusion Criteria:

* Having any gynecological disease (abnormal uterine bleeding, myoma, ovarian cysts, hormonal treatment, etc.),
* having a chronic or physical disease (serious hearing and vision problems, vestibular disorders that may cause balance losses),
* having any problem that prevents the person from communicating (not being able to speak Turkish, having speaking disabilities, impaired hearing, understanding abilities),
* undergoing a psychiatric treatment (pharmacotherapy or psychotherapy),
* performing one of the pharmacological or non-pharmacological practices aimed at reducing the symptoms of premenstrual symptoms (oral contraceptive use, acupressure, homeopathy, acupuncture) and exercising regularly.

Primary outcomes:
measure: Symptoms of premenstrual syndrome to reduce (PMSS) with music therapy
timeFrame: 14 days before application
measure: Quality of life increase with music therapy
timeFrame: 14 days before application
measure: Symptoms of premenstrual syndrome to reduce (PMSS)
timeFrame: 3 months
measure: Quality of life increase
timeFrame: 3 months
measure: The Student Information Form
timeFrame: 1 month
measure: The Premenstrual Syndrome Scale (PMSS)
timeFrame: 3 months
measure: Short form of the WHOQOL-BREF
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kırklareli
country: Turkey
facility: Kırklareli University
Study officials:
affiliation: Kırklareli University
name: AYCA SOLT KIRCA, Phd
role: STUDY_DIRECTOR
References: