Premenstrual SyndromeNCT05665972
Effects of Mandala Coloring on Premenstrual Syndrome
A study testing Mandala coloring in people with Premenstrual Syndrome, run by Kırklareli University at 1 site in Turkey (Türkiye).
Trial summary
This research was planned as a randomized controlled experimental study in order to reduce premenstrual syndrome symptoms of women with premenstrual syndrome. 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
- Premenstrual Syndrome
- What is being tested?
- Mandala coloring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 11 Jun 2024
- 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
- Volunteering to participate in the research
- Fully answering survey and scale forms.
- Ability to read and understand Turkish
- Being between the ages of 18 and 30 years
- Having regular menstruation (between 21 and 35 days)
- Having 45 or more from PMSS
Who cannot join
- Unwilling to continue working
- Having any problem that prevents communication (such as hearing, speaking, and understanding abilities),
- Having a gynecological disease (abnormal uterine bleeding, uterine fibroids, ovarian cysts, hormonal treatment, etc.)
- Having a chronic or physical illness
- Having a mental illness
- Being under psychiatric treatment (Pharmacotherapy or psychotherapy)
- Taking medication for menopausal symptoms
- Using one of the pharmacological or non-pharmacological methods to reduce premenstrual symptoms (COCs, acupressure, homeopathy, etc.)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kırklareli University
Kırklareli, Centre, 39000
About this study
Official title: Effects of Mandala Coloring on Premenstrual Syndrome: Randomized Controlled Experimental Study
This research was planned as a randomized controlled experimental study in order to reduce premenstrual syndrome symptoms of women with premenstrual syndrome.
Read the detailed description
Occurs in the luteal phase and decreases or declines significantly with the onset of menstruation; physical such as breast tenderness, headache, bloating; Premenstrual syndrome is a health problem with more than 150 psychological and behavioral symptoms such as anger outbursts, irritability, anxiety, mood fluctuations, sleep and eating disorders.
Symptoms experienced during the premenstrual period lead to results such as mood/affective disorder in women, deterioration in daily life activities and social relations, an increase in negative health behaviors, as well as low academic performance in students, decreased participation in classes, getting low grades in exams, and not showing up for exams.Since its etiology is unclear, no specific treatment method can be found, and non-pharmacological therapies such as stress control, lifestyle changes, exercise and complementary therapies such as evening primrose oil, chasteberry and acupuncture are applied in its management.
Psychiatrist Carl Gustav Jung discovered the psychic healing transformations created by mandala painting, one of the art therapy methods, through his own experience and that of his patients.
Various studies have determined that mandala coloring improves physical and psychological symptoms, but no studies have been conducted with PMS.
- Conditions
- Premenstrual Syndrome
- Being tested
- Mandala coloring
- Keywords
- Premenstrual syndrome, Mandala coloring
- 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 coloringOther
Each participant will be given 12 colored felt-tip pen paint sets and 12 mandala coloring pages by the researchers. Participants will be asked to dye for 3 menstrual cycles, 14 days before the start of menstruation, 1 day a week, at any time of the day and for an average of 20-30 minutes each time.
| Study group | Role | What they receive |
|---|---|---|
| Mandala coloring group | Experimental | Mandala painting will be applied to women suffering from premenstrual syndrome. Receives: Other: Mandala coloring |
| Control group | No intervention | Participants in this group will consist of people who do not routinely do any practice on their own to reduce premenstrual syndrome symptoms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Introductory Information Form
The form consists of questions about socio-demographic and menstrual periods.
Measured: between one to six months
Secondary outcomes (1)
Premenstrual Syndrome Scale
The Premenstrual Syndrome Scale was developed by Gençdoğan (2006) to measure premenstrual symptoms and determine their severity. It is a five-point Likert type scale (Never, Rarely, Sometimes, Frequently, Always) consisting of 44 items. The scale is scored as "Never" 1 point, "Rarely" 2 points, "Sometimes" 3 points, "Frequently" 4 points, and "Always" 5 points. The Premenstrual Syndrome Scale includes nine subdimensions which are depressive affect, anxiety, fatigue, irritability, depressive thoughts, pain, appetite change, sleep change, and bulge. The total Premenstrual Syndrome Scale score is obtained from the total points received from all nine subdimensions of the scale. A higher score from the scale means the intensity of Premenstrual Syndrome Scale symptoms increases too. The Cronbach's alpha coefficient of the scale was 0.75.
Measured: between one to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start1 Oct 2023
- Primary completion11 Jun 2024
- Study completion11 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premenstrual SyndromeStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırklareli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Efsun Derin, Kırklareli University
- Investigators
- Efsun DERİN, Principal investigator, Kırklareli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05665972
- Sponsor's protocol ID
- KırklareliED-2
- Status last verified
- Jul 2024
- First submitted
- 16 Dec 2022
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Derin E, Solt Kirca A. The Effect of Mandala Coloring on Premenstrual Syndrome: A Randomized Controlled Experimental Study. Holist Nurs Pract. 2026 Mar-Apr 01;40(2):123-130. doi: 10.1097/HNP.0000000000000724. Epub 2025 Nov 3.
PubMed 41177972
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mandala Coloring on Premenstrual Syndrome: Randomized Controlled Experimental Study
- ClinicalTrials.gov ID
- NCT05665972
- Acronym / sponsor ID
- KırklareliED-2
- Conditions
- Premenstrual Syndrome
- Keywords
- Premenstrual syndrome, Mandala coloring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kırklareli UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 11 Jun 2024 (actual)
- Study completion
- 11 Jun 2024 (actual)
- First posted
- 27 Dec 2022 (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.
This research was planned as a randomized controlled experimental study in order to reduce premenstrual syndrome symptoms of women with premenstrual syndrome.
Detailed description
Occurs in the luteal phase and decreases or declines significantly with the onset of menstruation; physical such as breast tenderness, headache, bloating; Premenstrual syndrome is a health problem with more than 150 psychological and behavioral symptoms such as anger outbursts, irritability, anxiety, mood fluctuations, sleep and eating disorders.
Symptoms experienced during the premenstrual period lead to results such as mood/affective disorder in women, deterioration in daily life activities and social relations, an increase in negative health behaviors, as well as low academic performance in students, decreased participation in classes, getting low grades in exams, and not showing up for exams.Since its etiology is unclear, no specific treatment method can be found, and non-pharmacological therapies such as stress control, lifestyle changes, exercise and complementary therapies such as evening primrose oil, chasteberry and acupuncture are applied in its management.
Psychiatrist Carl Gustav Jung discovered the psychic healing transformations created by mandala painting, one of the art therapy methods, through his own experience and that of his patients.
Various studies have determined that mandala coloring improves physical and psychological symptoms, but no studies have been conducted with PMS.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mandala coloring group | Experimental | Other: Mandala coloringMandala painting will be applied to women suffering from premenstrual syndrome. |
| Control group | No intervention | –Participants in this group will consist of people who do not routinely do any practice on their own to reduce premenstrual syndrome symptoms. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Volunteering to participate in the research
- Fully answering survey and scale forms.
- Ability to read and understand Turkish
- Being between the ages of 18 and 30 years
- Having regular menstruation (between 21 and 35 days)
Key exclusion criteria (8 listed)
- Unwilling to continue working
- Having any problem that prevents communication (such as hearing, speaking, and understanding abilities),
- Having a gynecological disease (abnormal uterine bleeding, uterine fibroids, ovarian cysts, hormonal treatment, etc.)
- Having a chronic or physical illness
- Having a mental illness
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 coloringEach participant will be given 12 colored felt-tip pen paint sets and 12 mandala coloring pages by the researchers. Participants will be asked to dye for 3 menstrual cycles, 14 days before the start of menstruation, 1 day a week, at any time of the day and for an average of 20-30 minutes each time. | Other | Mandala coloring group |
Primary outcome
Introductory Information Form
Time frame: between one to six months
The form consists of questions about socio-demographic and menstrual periods.
1 secondary outcome
Premenstrual Syndrome Scale
Time frame: between one to six months
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 18 Jul 2024.
- Derived from this study: PubMed 41177972Derin E, Solt Kirca A. The Effect of Mandala Coloring on Premenstrual Syndrome: A Randomized Controlled Experimental Study. Holist Nurs Pract. 2026 Mar-Apr 01;40(2):123-130. doi: 10.1097/HNP.0000000000000724. Epub 2025 Nov 3.
- 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.
Efsun DERİN principal investigator
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 Mandala coloring in people with 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 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: finished, as of the sponsor's last update on 18 Jul 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?
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?
Introductory Information Form (time frame: between one to six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05665972, which also lists 1 linked publication.
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 18 Jul 2024.