- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04955912
Music and Premenstrual Symptoms and Quality of Life
July 6, 2021 updated by: Ayca Solt Kirca, Kırklareli University
Effects of Music Medicine on Premenstrual Symptoms Levels and Quality of Life: A Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
89
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kırklareli, Turkey, 3900
- Kırklareli University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control group
not routinely do anything to reduce premenstrual symptoms
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Experimental: Experimental group
Music medicine
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To reduce premenstrual symptoms by applying music medicine to people with premenstrual syndrome
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptoms of premenstrual syndrome to reduce (PMSS) with music therapy
Time Frame: 14 days before application
|
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.
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14 days before application
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Quality of life increase with music therapy
Time Frame: 14 days before application
|
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.
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14 days before application
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Symptoms of premenstrual syndrome to reduce (PMSS)
Time Frame: 3 months
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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.
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3 months
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Quality of life increase
Time Frame: 3 months
|
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.
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3 months
|
The Student Information Form
Time Frame: 1 month
|
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
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1 month
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The Premenstrual Syndrome Scale (PMSS)
Time Frame: 3 months
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The PMSS was developed by Gençdoğan et al. (2006) to asses premenstrual symptom complaints (Gençdoğan 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 (Gençdoğan et al., 2006).
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3 months
|
Short form of the WHOQOL-BREF
Time Frame: 3 months
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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.
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3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: AYCA SOLT KIRCA, Phd, Kırklareli University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 30, 2021
Primary Completion (Actual)
April 15, 2021
Study Completion (Actual)
April 30, 2021
Study Registration Dates
First Submitted
June 13, 2021
First Submitted That Met QC Criteria
July 6, 2021
First Posted (Actual)
July 9, 2021
Study Record Updates
Last Update Posted (Actual)
July 9, 2021
Last Update Submitted That Met QC Criteria
July 6, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KırklareliAS-3
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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