Music and Premenstrual Symptoms and Quality of Life

Premenstrual Syndrome Clinical Trial

Official title:

Effects of Music Medicine on Premenstrual Symptoms Levels and Quality of Life: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04955912
• Other study ID #: KirklareliAS-3
• Status: Completed
• Phase: N/A
• Start date: January 30, 2021
• Est. completion date: April 30, 2021

Study information

• Verified date: July 2021
• Source: Kirklareli University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: April 30, 2021
• Est. primary completion date: April 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• MUSIC THERAPY
• Premenstrual Syndrome

Intervention

Other:
• music medicine
To reduce premenstrual symptoms by applying music medicine to people with premenstrual syndrome

Locations

Country	Name	City	State
Turkey	Kirklareli University	Kirklareli

Sponsors (1)

Lead Sponsor	Collaborator
Kirklareli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms of premenstrual syndrome to reduce (PMSS) with music therapy	The female students who met the inclusion criteria were included in the study. They were randomly assigned to the music (Group 1) and control (Group 2) groups. Before starting the application, participants were asked to fill out, the The Premenstrual Syndrome Scale (PMSS). Music group: The students listened to the playlists created specifically for each participant by an expert researcher who had received music therapy training after determining the music genres they liked during a menstrual cycle (14 days before the start of the cycle) 3 times a week for 30 minutes each time.	14 days before application
Primary	Quality of life increase with music therapy	The female students who met the inclusion criteria were included in the study. They were randomly assigned to the music (Group 1) and control (Group 2) groups. Before starting the application, participants were asked to fill out, the The Short form of the WHOQOL-BREF (the WHOQOL-BREF). Music group: The students listened to the playlists created specifically for each participant by an expert researcher who had received music therapy training after determining the music genres they liked during a menstrual cycle (14 days before the start of the cycle) 3 times a week for 30 minutes each time.	14 days before application
Primary	Symptoms of premenstrual syndrome to reduce (PMSS)	The participants who did not state their music preference were played classical music, a music genre expected to be effective in reducing their pain and anxiety. Since the control group consisted of people who did not make any application to reduce PMSS, no application was made to this. After the application, the experimental and control groups filled with the PMSS again.	3 months
Primary	Quality of life increase	The participants who did not state their music preference were played classical music, a music genre expected to be effective in reducing their pain and anxiety. Since the control group consisted of people who did not make any application to reduce PMSS, no application was made to this. After the application, the experimental and control groups filled with the WHOQOL-BREF again.	3 months
Primary	The Student Information Form	This form consists of 25 items questioning the woman's socio-demographic characteristics (age, height, weight, living region, family type, income status), information about her menstrual cycle, duration of her first menstruation, her age at the first menstruation (menarche), presence of chronic disease, menstrual symptoms, presence of a gynecologic disease, exercise status, and music preferences	1 month
Primary	The Premenstrual Syndrome Scale (PMSS)	The PMSS was developed by Gençdogan et al. (2006) to asses premenstrual symptom complaints (Gençdogan et al., 2006). The scale is a 5-point Likert type and it consists of 44 items.The scale has nine subscales including depressive affection, anxiety, fatigue, irritability, depressive thoughts, pain, changes in appetite, sleep changes, and swelling. The premenstrual syndrome scale is administered by evaluating retrospectively, in other words, the week before the menstruation is taken into account. The overall premenstrual syndrome scale score is the sum of the scores of the nine subscales.The minimum and maximum possible scores to be obtained from this easily self-administered PMSS are 44 and 220 respectively. While the score of 44 points means no PMS, points between 45 and 103 indicate mild PMS, points between 104 and 163 indicate moderate PMS, and points between 164 and 220 severe PMS (Gençdogan et al., 2006).	3 months
Primary	Short form of the WHOQOL-BREF	The World Health Organization (WHO) developed the WHOQOL-100 scale (Whoqol et al., 1998). The validity and reliability study of the Turkish version of the WHOQOL-BREF was performed by Eser (Eser et al., 1998). The WHOQOL-BREF consists of four domains, namely physical health, psychological health, social relationships, and environment. Responses given to the items are rated on a 5-point Likert type scale. The questions are answered by considering the last 15 days. The WHOQOL-BREF doesn't have a total score. The score of each domain indicates the level of quality of life for that domain. The higher the score is the better the quality of life is. The first two questions of the scale are not included in the scoring and are evaluated separately. The 3rd, 4th, and 26th questions in the scale are negatively keyed expressions (Whoqol et al., 1998; Skevington et al., 2004). While the original scale has 26 items, the Turkish version has 27 items.	3 months