Menstruation; SyndromeNCT06314165
Evaluation of the Effect of Music Medicine Application on Menstrual Symptoms
A study testing music medicine practice in people with Menstruation; Syndrome, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
In this study, the "Music Medicine Application" method was chosen in line with the literature and guidelines and it is aimed to determine whether it is effective in reducing the symptoms experienced by female students with "Music Medicine Application" during the menstrual period. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstruation; Syndrome
- What is being tested?
- music medicine practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2024to Feb 2025
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Volunteering to participate in the research
- Menstrual cycle length has been within normal limits (21-35) for the last 3 months
- Not using oral contraceptives for the last 3 months
- Not having any psychiatric problems and not receiving any treatment for this in the last 3 months.
- Not using painkillers or any pharmacological agents or methods that reduce symptoms during the study.
- Participants who marked 1.1-10 according to Visüel analog scala
Who cannot join
- Presence of chronic diseases or serious medical conditions
- Presence of another physical or psychological disorder that may affect menstrual symptoms
- Presence of psychiatric or psychological disorders
- Active drug use or hormone therapy
- Having given birth
- Answering survey questions incompletely or not answering them
- Participants who marked 0-1 according to Visüel analog scala
- Not applying music medicine for the experimental group
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Pamukkale University Faculty of Health Sciences
Denizli, 20180
Rabia Nur Doğan, +905528400797, rabianur_1997@hotmail.com
About this study
In this study, the "Music Medicine Application" method was chosen in line with the literature and guidelines and it is aimed to determine whether it is effective in reducing the symptoms experienced by female students with "Music Medicine Application" during the menstrual period.
Read the detailed description
This study aims to determine whether the application of music medicine is effective in reducing the symptoms experienced by female students during the menstrual period. The type of research was planned as a prospective, randomized controlled experimental study with a pretest-posttest control group. The research will be conducted with female students studying at Pamukkale University Faculty of Health Sciences. The data of the research will be collected between March 2024 and February 2025. Personal Information Form, Visual Analogue Scale and Menstruation Symptom Scale will be used to collect data. It was determined that a total of 62 people should participate in the research, 31 in the experimental group and 31 in the control group. As the randomization method, "simple randomization" will be used to ensure an equal number of samples in the experimental and control groups. Randomization will be done using the www.randomizer.org application. The data will be analyzed using the SPSS (23.0) package program. Continuous variables will be given as mean ± standard deviation and categorical variables will be given as number and percentage. Significance Test of Difference Between Two Means in comparing independent group differences when parametric test assumptions are met; When parametric test assumptions are not met, Mann-Whitney U test will be used to compare independent group differences.
- Conditions
- Menstruation; Syndrome
- Being tested
- music medicine practice
- Keywords
- music medicine, menstruation symptom, menstrual pain
- Medical subject headings
- Menstruation Disturbances, Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music medicine practiceOther
Music medicine will be applied
| Study group | Role | What they receive |
|---|---|---|
| group practicing music medicine | Experimental | There will be 2 follow-ups for each group. In the first follow-up for the experimental group, when symptoms begin on the first day of their menstrual period, they will be asked to fill out the Menstruation Symptom Scale and Visual Analogue Scale, and the designated music will be played for 30 minutes. After 30 minutes, he/she will be asked to fill out the same surveys again. In the 2nd follow-up (during the menstrual period one month after the first follow-up), they will be asked to repeat what was done in the 1st follow-up on the first day of their menstrual period. Receives: Other: music medicine practice |
| Group where music medicine is not applied | No intervention | Two follow-ups will be applied to the groups. At the first follow-up for the control group, they will be asked to fill out the Menstruation Symptom Scale and Visual Analog Scale when symptoms begin on the first day of their menstrual period. In the 2nd follow-up (during the menstrual period one month after the first follow-up), they will be asked to repeat what was done in the 1st follow-up on the first day of their menstrual period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
menstruation symptom scale
Participants are asked to rate the symptoms they experience regarding menstruation between 1 (never) and 5 (always). Scale items are numbered according to certain factors for ease of use. Items 1-13 belong to the "Negative effects/somatic complaints" subcategory, items 14-19 belong to the "Menstrual pain symptoms" subcategory, and items 20-22 belong to the "Coping methods" subcategory. A five-point Likert type was used in the Menstruation Symptom Scale, which consists of 22 items. The score obtained from the sub-dimensions is calculated by taking the total score average of the items in the relevant sub-dimension. An increase in the mean score for sub-dimensions indicates that the severity of menstrual symptoms in that sub-dimension has increased.
Measured: Two months
Secondary outcomes (1)
Visual Analogue Scale
Participants were included in the "healthy" category when they marked the 0-1 range of the scale, and were included in the "Menstruation pain" category when they marked the 1.1-10 range. They were divided into 3 groups according to pain severity. 1.1-3: Mild pain, 3.1-7: Moderate pain, 7.1-10: Severe pain.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start10 Mar 2024
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstruation; SyndromeStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- 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
- Two groups: comparative experiment and control
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevgi Özkan, Pamukkale University
- Investigators
- Sevgi Özkan Professor Doctor, Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314165
- Sponsor's protocol ID
- PamukkaleU-SBE-RND-01
- Status last verified
- Mar 2024
- First submitted
- 10 Mar 2024
- Last updated
- 21 Mar 2024
- 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 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Music Medicine Application on Menstrual Symptoms
- ClinicalTrials.gov ID
- NCT06314165
- Acronym / sponsor ID
- PamukkaleU-SBE-RND-01
- Conditions
- Menstruation; Syndrome
- Keywords
- music medicine, menstruation symptom, menstrual pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 10 Mar 2024 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 15 Mar 2024 (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.
In this study, the "Music Medicine Application" method was chosen in line with the literature and guidelines and it is aimed to determine whether it is effective in reducing the symptoms experienced by female students with "Music Medicine Application" during the menstrual period.
Detailed description
This study aims to determine whether the application of music medicine is effective in reducing the symptoms experienced by female students during the menstrual period. The type of research was planned as a prospective, randomized controlled experimental study with a pretest-posttest control group. The research will be conducted with female students studying at Pamukkale University Faculty of Health Sciences. The data of the research will be collected between March 2024 and February 2025. Personal Information Form, Visual Analogue Scale and Menstruation Symptom Scale will be used to collect data. It was determined that a total of 62 people should participate in the research, 31 in the experimental group and 31 in the control group. As the randomization method, "simple randomization" will be used to ensure an equal number of samples in the experimental and control groups. Randomization will be done using the www.randomizer.org application. The data will be analyzed using the SPSS (23.0) package program. Continuous variables will be given as mean ± standard deviation and categorical variables will be given as number and percentage. Significance Test of Difference Between Two Means in comparing independent group differences when parametric test assumptions are met; When parametric test assumptions are not met, Mann-Whitney U test will be used to compare independent group differences.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two groups: comparative experiment and control
| Arm | Type | Receives |
|---|---|---|
| group practicing music medicine | Experimental | Other: music medicine practiceThere will be 2 follow-ups for each group. In the first follow-up for the experimental group, when symptoms begin on the first day of their menstrual period, they will be asked to fill out the Menstruation Symptom Scale and Visual Analogue Scale, and the designated music will be played for 30 minutes. After 30 minutes, he/she will be asked to fill out the same surveys again. In the 2nd follow-up (during the menstrual period one month after the first follow-up), they will be asked to repeat what was done in the 1st follow-up on the first day of their menstrual period. |
| Group where music medicine is not applied | No intervention | –Two follow-ups will be applied to the groups. At the first follow-up for the control group, they will be asked to fill out the Menstruation Symptom Scale and Visual Analog Scale when symptoms begin on the first day of their menstrual period. In the 2nd follow-up (during the menstrual period one month after the first follow-up), they will be asked to repeat what was done in the 1st follow-up on the first day of their menstrual period. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Volunteering to participate in the research
- Menstrual cycle length has been within normal limits (21-35) for the last 3 months
- Not using oral contraceptives for the last 3 months
- Not having any psychiatric problems and not receiving any treatment for this in the last 3 months.
- Not using painkillers or any pharmacological agents or methods that reduce symptoms during the study.
Key exclusion criteria (8 listed)
- Presence of chronic diseases or serious medical conditions
- Presence of another physical or psychological disorder that may affect menstrual symptoms
- Presence of psychiatric or psychological disorders
- Active drug use or hormone therapy
- Having given birth
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 medicine practiceMusic medicine will be applied | Other | group practicing music medicine |
Primary outcome
menstruation symptom scale
Time frame: Two months
Participants are asked to rate the symptoms they experience regarding menstruation between 1 (never) and 5 (always). Scale items are numbered according to certain factors for ease of use. Items 1-13 belong to the "Negative effects/somatic complaints" subcategory, items 14-19 belong to the "Menstrual pain symptoms" subcategory, and items 20-22 belong to the "Coping methods" subcategory. A five-point Likert type was used in the Menstruation Symptom Scale, which consists of 22 items. The score obtained from the sub-dimensions is calculated by taking the total score average of the items in the relevant sub-dimension. An increase in the mean score for sub-dimensions indicates that the severity of menstrual symptoms in that sub-dimension has increased.
1 secondary outcome
Visual Analogue Scale
Time frame: Two months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- 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.
Sevgi Özkan Professor Doctor principal investigator
Pamukkale 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 practice in people with Menstruation; Syndrome, run by Pamukkale 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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 21 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rabia Nur Doğan (+905528400797, rabianur_1997@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
menstruation symptom scale (time frame: Two months). 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 21 Mar 2024.