Back to resultsMusic and Premenstrual Symptoms and Quality of Life
Primary Purpose
MUSIC THERAPY, Premenstrual Syndrome
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
music medicine
Sponsored by
About this trial
This is an interventional supportive care trial for MUSIC THERAPY focused on measuring Premenstrual syndrome, music medicine, quality life, midwife, nurse
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.
Sites / Locations
- Kırklareli University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental group
Control group
Arm Description
Music medicine
not routinely do anything to reduce premenstrual symptoms
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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
The Premenstrual Syndrome Scale (PMSS)
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).
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04955912
Brief Title
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
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 30, 2021 (Actual)
Primary Completion Date
April 15, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kırklareli University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MUSIC THERAPY, Premenstrual Syndrome
Keywords
Premenstrual syndrome, music medicine, quality life, midwife, nurse
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled clinical trial
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Music medicine
Arm Title
Control group
Arm Type
No Intervention
Arm Description
not routinely do anything to reduce premenstrual symptoms
Intervention Type
Other
Intervention Name(s)
music medicine
Intervention Description
To reduce premenstrual symptoms by applying music medicine to people with premenstrual syndrome
Primary Outcome Measure Information:
Title
Symptoms of premenstrual syndrome to reduce (PMSS) with music therapy
Description
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.
Time Frame
14 days before application
Title
Quality of life increase with music therapy
Description
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.
Time Frame
14 days before application
Title
Symptoms of premenstrual syndrome to reduce (PMSS)
Description
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.
Time Frame
3 months
Title
Quality of life increase
Description
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.
Time Frame
3 months
Title
The Student Information Form
Description
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
Time Frame
1 month
Title
The Premenstrual Syndrome Scale (PMSS)
Description
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).
Time Frame
3 months
Title
Short form of the WHOQOL-BREF
Description
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.
Time Frame
3 months
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AYCA SOLT KIRCA, Phd
Organizational Affiliation
Kırklareli University
Official's Role
Study Director
Facility Information:
Facility Name
Kırklareli University
City
Kırklareli
ZIP/Postal Code
3900
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Music and Premenstrual Symptoms and Quality of Life
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