MUSIC THERAPYNCT04955912
Music and Premenstrual Symptoms and Quality of Life
A study testing music medicine in people with MUSIC THERAPY and Premenstrual Syndrome, run by Kırklareli University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- MUSIC THERAPY, Premenstrual Syndrome
- What is being tested?
- music medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jan 2021to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- MUSIC THERAPY, Premenstrual Syndrome
- Being tested
- music medicine
- Keywords
- Premenstrual syndrome, music medicine, quality life, midwife, nurse
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music medicineOther
To reduce premenstrual symptoms by applying music medicine to people with premenstrual syndrome
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Music medicine Receives: Other: music medicine |
| Control group | No intervention | not routinely do anything to reduce premenstrual symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days before application
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.
Measured: 14 days before application
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.
Measured: 3 months
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.
Measured: 3 months
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
Measured: 1 month
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).
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start30 Jan 2021
- Primary completion15 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MUSIC THERAPYStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırklareli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayca Solt Kirca, Kırklareli University
- Investigators
- AYCA SOLT KIRCA, Phd, Study director, Kırklareli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955912
- Sponsor's protocol ID
- KırklareliAS-3
- Status last verified
- Jul 2021
- First submitted
- 13 Jun 2021
- Last updated
- 9 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Music Medicine on Premenstrual Symptoms Levels and Quality of Life: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04955912
- Acronym / sponsor ID
- KırklareliAS-3
- Conditions
- MUSIC THERAPY, Premenstrual Syndrome
- Keywords
- Premenstrual syndrome, music medicine, quality life, midwife, nurse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Kırklareli UniversityUniversity, hospital or other
- Study start
- 30 Jan 2021 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 9 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: music medicineMusic medicine |
| Control group | No intervention | –not routinely do anything to reduce premenstrual symptoms |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| music medicineTo reduce premenstrual symptoms by applying music medicine to people with premenstrual syndrome | Other | Experimental group |
Primary outcome
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.
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.
Symptoms of premenstrual syndrome to reduce (PMSS)
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 PMSS again.
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.
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
The Premenstrual Syndrome Scale (PMSS)
Time frame: 3 months
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
Time frame: 3 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AYCA SOLT KIRCA, Phd study director
Kırklareli University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing music medicine in people with MUSIC THERAPY and Premenstrual Syndrome, run by Kırklareli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms of premenstrual syndrome to reduce (PMSS) with music therapy (time frame: 14 days before application). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2021.