Mandala ColoringNCT07097558
Mandala and Music for PMS Relief
A study testing Mandala coloring group and Music listening group in people with Mandala Coloring and Music Listening, run by Rukiye Duman at 1 site in Turkey (Türkiye).
Trial summary
Purpose: The aim of this project is to examine the effects of mandala painting and music performance interventions on premenstrual syndrome symptoms and quality of life. The hypotheses of the study are as follows: Coloring mandalas has a positive effect on premenstrual syndrome symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mandala Coloring, Music Listening, Premenstrual Syndrome-PMS
- What is being tested?
- Mandala coloring group and Music listening group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Aug 2025to 1 May 2026
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be an undergraduate student studying midwifery at Istanbul University-Cerrahpaşa Faculty of Health Sciences.
- Must have a score of 110 or higher on the PMSS.
- Must have an internet connection.
Who cannot join
- Must be under 18 years of age.
- Must have a change in menstrual cycle characteristics after being diagnosed with PMS.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University- Cerrahpasa
Istanbul, AVCILAR
About this study
Official title: The Effect of Mandala Coloring and Music Listening on Premenstrual Syndrome Symptoms and Quality of Life: A Randomized Controlled Trial
Purpose: The aim of this project is to examine the effects of mandala painting and music performance interventions on premenstrual syndrome symptoms and quality of life.
The hypotheses of the study are as follows:
Coloring mandalas has a positive effect on premenstrual syndrome symptoms. Listening to music has a positive effect on premenstrual syndrome symptoms. Listening to music has a positive effect on quality of life. Coloring mandalas has a positive effect on quality of life.
Read the detailed description
Objective: The aim of this project is to examine the effects of mandala coloring and music performance interventions on premenstrual syndrome symptoms and quality of life.
The study aims to reach all students experiencing premenstrual syndrome symptoms without resorting to sample size calculations. Therefore, since a high effect size is expected in the study, Cohen's standard effect size of 0.25, which is between moderate and large, was accepted. Therefore (α = 0.05, effect size = 0.25, 1-β = 0.80), the minimum sample size was calculated as 108 participants (n = 36 for each group).
The study includes a mandala coloring group, a music performance group, and a control group. The mandala coloring intervention will be applied twice a week for 8 weeks, and the music performance will be applied twice a day for 30 minutes for 8 weeks. Participants in the music performance group will listen to classical music. The control group will not receive any intervention. The Demographic Information Form, the Premenstrual Syndrome Scale (PMSS), and the WHOQOL-BREF-TR Quality of Life Scale will be used as data collection tools. The first measurement will be administered before the interventions. The second measurement will be collected in the fourth week after the intervention, and the third measurement in the eighth week. The data obtained in the study will be entered into a database using IBM SPSS 25.0 (Statistical Package for Social Sciences), and all necessary statistical analyses will be performed in the same program.
- Conditions
- Mandala Coloring, Music Listening, Premenstrual Syndrome-PMS
- Being tested
- Mandala coloring group, Music listening group, control group
- Keywords
- Music Listening, music, art therapy, mandala coloring, Premenstrual Syndrome
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandala coloring groupOther
The mandala painting intervention will be administered twice a week for 8 weeks for the mandala coloring group.
Music listening groupOther
The music listening group will listen to classical music twice a week for 8 weeks for 30 minutes, twice a day.
control groupOther
The control group will not receive any intervention.
| Study group | Role | What they receive |
|---|---|---|
| Mandala coloring group | Experimental | The mandala painting intervention will be administered twice a week for 8 weeks for the mandala painting group. Receives: Other: Mandala coloring group |
| Music listening group | Experimental | The music listening group will listen to classical music twice a week for 8 weeks for 30 minutes, twice a day. Receives: Other: Music listening group |
| Control group | Experimental | The control group will not receive any intervention. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect of Mandala Coloring on Premenstrual Syndrome Symptoms
Premenstrual Syndrome Scale (PMSS): Developed by Gençdoğan in 2006, this five-point Likert-type scale measures the severity of premenstrual problems, consisting of 44 items and nine subscales. The lowest possible score is 44, and the highest is 220. A higher score indicates a greater severity of PMS problems.
Measured: eight weeks
The Effect of MMusic Listening on Premenstrual Syndrome Symptoms
Premenstrual Syndrome Scale (PMSS): Developed by Gençdoğan in 2006, this five-point Likert-type scale measures the severity of premenstrual problems, consisting of 44 items and nine subscales. The lowest possible score is 44, and the highest is 220. A higher score indicates a greater severity of PMS problems.
Measured: eight weeks
Secondary outcomes (2)
The Effect of Mandala Coloring Quality of Life
WHOQOL-BREF-TR Quality of Life Scale: The Turkish version of the scale has been shown to be valid and reliable. The scale includes subdomains of physical health, psychological health, social relationships, and environment and culture-standardized environmental assessment. Each domain is scored between 4 and 20, with higher scores indicating higher quality of life in that area.
Measured: eight weeks
The Effect of Music Listening on Quality of Life
WHOQOL-BREF-TR Quality of Life Scale: The Turkish version of the scale has been shown to be valid and reliable. The scale includes subdomains of physical health, psychological health, social relationships, and environment and culture-standardized environmental assessment. Each domain is scored between 4 and 20, with higher scores indicating higher quality of life in that area.
Measured: eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start13 Aug 2025
- Primary completion31 Mar 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandala ColoringStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study includes a mandala coloring group, a music group, and a control group. Participating students will be informed about the study and provided with an "Informed Consent Form" and a "Voluntary Consent Form." The mandala painting intervention will be administered twice a week for 8 weeks to the mandala painting group, and the music performance will be administered twice a week for 30 minutes, twice a day, for 8 weeks. Participants in the music performance group will listen to classical music. The control group will not receive any intervention. Data will be collected using a "The Demographic Information Form," the "Premenstrual Syndrome Scale (PMSS)," and the "WHOQOL-BREF-TR Quality of Life Scale."
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rukiye Duman
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Sponsor-investigator, Rukiye Duman, Istanbul University - Cerrahpasa
- Investigators
- RUKIYE DUMAN, RESEARCH ASSISTANT, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07097558
- Sponsor's protocol ID
- IstanbulUC-EBE-RD-01
- Status last verified
- Aug 2025
- First submitted
- 25 Jul 2025
- Last updated
- 13 Jul 2026
- 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 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mandala Coloring and Music Listening on Premenstrual Syndrome Symptoms and Quality of Life: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07097558
- Acronym / sponsor ID
- IstanbulUC-EBE-RD-01
- Conditions
- Mandala Coloring, Music Listening, Premenstrual Syndrome-PMS
- Keywords
- Music Listening, music, art therapy, mandala coloring, Premenstrual Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Rukiye DumanUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 13 Aug 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 31 Jul 2025 (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.
Purpose: The aim of this project is to examine the effects of mandala painting and music performance interventions on premenstrual syndrome symptoms and quality of life.
The hypotheses of the study are as follows:
Coloring mandalas has a positive effect on premenstrual syndrome symptoms. Listening to music has a positive effect on premenstrual syndrome symptoms. Listening to music has a positive effect on quality of life. Coloring mandalas has a positive effect on quality of life.
Detailed description
Objective: The aim of this project is to examine the effects of mandala coloring and music performance interventions on premenstrual syndrome symptoms and quality of life.
The study aims to reach all students experiencing premenstrual syndrome symptoms without resorting to sample size calculations. Therefore, since a high effect size is expected in the study, Cohen's standard effect size of 0.25, which is between moderate and large, was accepted. Therefore (α = 0.05, effect size = 0.25, 1-β = 0.80), the minimum sample size was calculated as 108 participants (n = 36 for each group).
The study includes a mandala coloring group, a music performance group, and a control group. The mandala coloring intervention will be applied twice a week for 8 weeks, and the music performance will be applied twice a day for 30 minutes for 8 weeks. Participants in the music performance group will listen to classical music. The control group will not receive any intervention. The Demographic Information Form, the Premenstrual Syndrome Scale (PMSS), and the WHOQOL-BREF-TR Quality of Life Scale will be used as data collection tools. The first measurement will be administered before the interventions. The second measurement will be collected in the fourth week after the intervention, and the third measurement in the eighth week. The data obtained in the study will be entered into a database using IBM SPSS 25.0 (Statistical Package for Social Sciences), and all necessary statistical analyses will be performed in the same program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- The study includes a mandala coloring group, a music group, and a control group. Participating students will be informed about the study and provided with an "Informed Consent Form" and a "Voluntary Consent Form." The mandala painting intervention will be administered twice a week for 8 weeks to the mandala painting group, and the music performance will be administered twice a week for 30 minutes, twice a day, for 8 weeks. Participants in the music performance group will listen to classical music. The control group will not receive any intervention. Data will be collected using a "The Demographic Information Form," the "Premenstrual Syndrome Scale (PMSS)," and the "WHOQOL-BREF-TR Quality of Life Scale."
| Arm | Type | Receives |
|---|---|---|
| Mandala coloring group | Experimental | Other: Mandala coloring groupThe mandala painting intervention will be administered twice a week for 8 weeks for the mandala painting group. |
| Music listening group | Experimental | Other: Music listening groupThe music listening group will listen to classical music twice a week for 8 weeks for 30 minutes, twice a day. |
| Control group | Experimental | Other: control groupThe control group will not receive any intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must be an undergraduate student studying midwifery at Istanbul University-Cerrahpaşa Faculty of Health Sciences.
- Must have a score of 110 or higher on the PMSS.
- Must have an internet connection.
Key exclusion criteria (2 listed)
- Must be under 18 years of age.
- Must have a change in menstrual cycle characteristics after being diagnosed with PMS.
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 |
|---|---|---|
| Mandala coloring groupThe mandala painting intervention will be administered twice a week for 8 weeks for the mandala coloring group. | Other | Mandala coloring group |
| Music listening groupThe music listening group will listen to classical music twice a week for 8 weeks for 30 minutes, twice a day. | Other | Music listening group |
| control groupThe control group will not receive any intervention. | Other | Control group |
Primary outcome
The Effect of Mandala Coloring on Premenstrual Syndrome Symptoms
Time frame: eight weeks
Premenstrual Syndrome Scale (PMSS): Developed by Gençdoğan in 2006, this five-point Likert-type scale measures the severity of premenstrual problems, consisting of 44 items and nine subscales. The lowest possible score is 44, and the highest is 220. A higher score indicates a greater severity of PMS problems.
The Effect of MMusic Listening on Premenstrual Syndrome Symptoms
Time frame: eight weeks
Premenstrual Syndrome Scale (PMSS): Developed by Gençdoğan in 2006, this five-point Likert-type scale measures the severity of premenstrual problems, consisting of 44 items and nine subscales. The lowest possible score is 44, and the highest is 220. A higher score indicates a greater severity of PMS problems.
2 secondary outcomes
The Effect of Mandala Coloring Quality of Life
Time frame: eight weeks
The Effect of Music Listening on Quality of Life
Time frame: eight weeks
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 13 Jul 2026.
- 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.
RUKIYE DUMAN, RESEARCH ASSISTANT principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandala coloring group and Music listening group in people with Mandala Coloring and Music Listening, run by Rukiye Duman 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 3 inclusion and 2 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 13 Jul 2026. 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?
The Effect of Mandala Coloring on Premenstrual Syndrome Symptoms (time frame: eight weeks). The study lists 2 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 13 Jul 2026.