Premenstrual SyndromeMANDALANCT06176313
Effects of Training Given to Cope With Premenstrual Syndrome and Mandala Activity on Premenstrual Symptoms
A study testing Mandala Group and Coping with Premenstrual Symptoms Education Group in people with Premenstrual Syndrome, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
The research employs a pre-test post-test control group design with a randomized controlled semi-experimental approach to determine the impact of education provided for coping with premenstrual syndrome and Mandala activity on premenstrual symptoms. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- Mandala Group and Coping with Premenstrual Symptoms Education Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Oct 2023to 31 Jan 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 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18-25 years
- Female students enrolled in the 1st and 2nd years of the Faculty of Health Sciences PMSÖ score of 110 and above
- Regular menstruation in the last six months (between 21-35 days)
- Not using any medication or non-medication methods to cope with PMS symptoms
- Not using contraceptive pills
- Absence of any gynecological diseases (abnormal uterine bleeding, fibroids, ovarian cysts, etc.)
Show all 14Show fewer
- No diagnosis of psychiatric illness
- Not using any psychiatric medication such as antidepressants
- Absence of any condition that may hinder Mandala drawing
- No previous experience with Mandala education
- Willingness to participate in the study
- Proficiency in speaking and understanding Turkish
- Exclusion Criteria: Students who do not meet the criteria mentioned above and are not willing to participate in the study will be excluded.
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bilecik Şeyh Edebali University
Bilecik, Merkez, 11100
MERVE SEZER YILDIZ, Ph.D.Stdnt, 05301789126, mervesezer55@gmail.com
mervesezer55@gmail.com
About this study
Official title: Investigation of the Effects of Training Given to Cope With Premenstrual Syndrome and Mandala Activity on Premenstrual Symptoms
The research employs a pre-test post-test control group design with a randomized controlled semi-experimental approach to determine the impact of education provided for coping with premenstrual syndrome and Mandala activity on premenstrual symptoms.
Research Hypotheses:
Read more
H01: Mandala activity is not effective in reducing premenstrual symptoms.
H02: Education provided for coping with premenstrual syndrome is not effective in reducing premenstrual symptoms.
H13: Mandala activity is effective in reducing premenstrual symptoms.
H14: Education provided for coping with premenstrual syndrome is effective in reducing premenstrual symptoms.
H15: Mandala activity is more effective than education provided for coping with premenstrual syndrome in reducing premenstrual symptoms among students with PMS.
Research Groups: Mandala Group, Coping with Premenstrual Symptoms Education Group, and Control Group.
Read the detailed description
In the conducted international and national literature review, it was observed that various methods are utilized in the management of PMS. Still, no study directly examining the effectiveness of Mandala activity on PMS was found. The literature results provided under the title of Mandala indicate that the activities are predominantly focused on behavioral and psychological conditions. Considering the symptoms of PMS, it is assumed that Mandala activity may have an impact on the behavioral and psychological symptoms of PMS. The assumption of how it might affect the physical symptoms of PMS is also supported by studies indicating that art itself has a therapeutic quality and that the creative process helps individuals develop positive coping methods for the physical discomfort they experience.
The research is planned as a pre-test post-test control group design with a randomized controlled semi-experimental approach, aiming to determine the impact of education on coping with premenstrual syndrome and Mandala activity on premenstrual symptoms
Research Hypotheses:
H01: Mandala activity is not effective in reducing premenstrual symptoms.
H02: Education provided for coping with premenstrual syndrome is not effective in reducing premenstrual symptoms.
H13: Mandala activity is effective in reducing premenstrual symptoms.
H14: Education provided for coping with premenstrual syndrome is effective in reducing premenstrual symptoms.
H15: Mandala activity is more effective than education provided for coping with premenstrual syndrome in reducing premenstrual symptoms among students with PMS.
Research Groups: Mandala Group, Coping with Premenstrual Symptoms Education Group, and Control Group.
- Conditions
- Premenstrual Syndrome
- Being tested
- Mandala Group, Coping with Premenstrual Symptoms Education Group, Control Group
- Keywords
- premenstrual syndrome, mandala, education, premenstrual symptoms
- 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 GroupOther
The Mandala activity lasts approximately 60 minutes.
- A calm environment is provided during the Mandala activity, and participants are ensured not to be disturbed by external stimuli or individuals unless they request assistance.
Each student's last menstrual date is recorded in an Excel table.
- Two days before the intervention day, students will be contacted and invited to participate in the study.
- Monitoring each student's menstrual cycle, the Mandala activity intervention is scheduled during the late luteal phase of each student's menstrual cycle. The intervention is planned within the 5 days before the expected start of menstrual bleeding on days and hours convenient for the student's class schedule.
- After each session, on the 4th day of the expected menstrual bleeding, students are subjected to PMSÖ.
- On the 4th day of the 4th menstrual period bleeding, the research will be concluded by applying the post-test with PMSÖ to the students."
Coping with Premenstrual Symptoms Education GroupOther
The education will be conducted through face-to-face interviews in the master's course classroom at the Faculty of Health Sciences at Bilecik Şeyh Edebali University. The education was conducted using PowerPoint presentations projected onto a white smartboard.
- One month after the completion of the education, a 1st Reminder training will be provided in the master's course classroom within the Faculty of Health Sciences at Bilecik Şeyh Edebali University, using the face-to-face interview method.
- One month after the 1st Reminder training, a 2nd Reminder training will be provided in the master's course classroom within the Faculty of Health Sciences at Bilecik Şeyh Edebali University, using the face-to-face interview method.
- On the 4th day of the 4th menstrual period bleeding, the research will be concluded by applying the post-test with PMSÖ to the students.
Control GroupOther
No intervention will be applied to the control group throughout the research. However, students in this group who cope with premenstrual syndrome using medication or non-medication methods will be monitored during the three-month menstrual cycle.
Each student's menstrual cycle in the control group has been recorded in the Excel table. The estimated end of menstruation for each student has been noted.
- At the estimated end of menstruation, the researcher contacts the students in the control group to inquire whether they have used any medication or non-medication methods to cope with premenstrual syndrome.
- Those who use medication or non-medication methods to reduce premenstrual symptoms are excluded from the study.
- On the 4th day of the 4th menstrual period bleeding, the post-test with PMSÖ will be applied to the students."
| Study group | Role | What they receive |
|---|---|---|
| mandala | Experimental | Not described Receives: Other: Mandala Group |
| Coping with Premenstrual Symptoms Education Group | Experimental | Not described Receives: Other: Coping with Premenstrual Symptoms Education Group |
| Control Group | Experimental | Not described Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Premenstrual Syndrome Scale (PSS) for mandala pre-test
The Premenstrual Syndrome Scale (PMSS): The PMSS consists of 44 items. The total PMSS score is obtained by summing the scores of subscales. The lowest score that can be obtained on the scale is 44, and the highest score is 220. Higher scores indicate increased severity of PMS symptoms.
Measured: pre-test
the Premenstrual Syndrome Scale (PSS) for education pre-test
The Premenstrual Syndrome Scale (PMSS): The PMSS consists of 44 items. The total PMSS score is obtained by summing the scores of subscales. The lowest score that can be obtained on the scale is 44, and the highest score is 220. Higher scores indicate increased severity of PMS symptoms.
Measured: pre-test
the Premenstrual Syndrome Scale (PSS) for control
The Premenstrual Syndrome Scale (PMSS): The PMSS consists of 44 items. The total PMSS score is obtained by summing the scores of subscales. The lowest score that can be obtained on the scale is 44, and the highest score is 220. Higher scores indicate increased severity of PMS symptoms.
Measured: pre-test
Secondary outcomes (5)
the Premenstrual Syndrome Scale (PSS) after mandala-1 session
Mandala sessions are conducted with students approximately 7 days before each monthly menstrual bleeding. The sessions are planned in a total of 3 sessions. Four days after each mandala session, students fill out the Premenstrual Syndrome Scale (PSS) form. The result obtained at this time represents the PSS outcome after the 1st Mandala session.
Students who scored 110 or above on the Premenstrual Syndrome Scale (PSS) and met the inclusion criteria of the study were randomly assigned to study groups. The scores obtained by the included students on the PSS were considered as the pre-test for the study.
The Premenstrual Syndrome Scale (PMSS): The PMSS consists of 44 items. The total PMSS score is obtained by summing the scores of subscales. The lowest score that can be obtained on the scale is 44, and the highest score is 220. Higher scores indicate increased severity of PMS symptoms.
Measured: Four days after the first menstrual bleeding.
the Premenstrual Syndrome Scale (PSS) after mandala-2 session
Mandala sessions are conducted with students approximately 7 days before each monthly menstrual bleeding. The sessions are planned in a total of 3 sessions. Four days after each mandala session, students fill out the Premenstrual Syndrome Scale (PSS) form. The result obtained at this time represents the PSS outcome after the 2st Mandala session.
Students who scored 110 or above on the Premenstrual Syndrome Scale (PSS) and met the inclusion criteria of the study were randomly assigned to study groups. The scores obtained by the included students on the PSS were considered as the pre-test for the study.
The Premenstrual Syndrome Scale (PMSS): The PMSS consists of 44 items. The total PMSS score is obtained by summing the scores of subscales. The lowest score that can be obtained on the scale is 44, and the highest score is 220. Higher scores indicate increased severity of PMS symptoms.
Measured: Four days after the second menstrual bleeding."
the Premenstrual Syndrome Scale (PSS) after mandala-3 session
Mandala sessions are conducted with students approximately 7 days before each monthly menstrual bleeding. The sessions are planned in a total of 3 sessions. Four days after each mandala session, students fill out the Premenstrual Syndrome Scale (PSS) form. The result obtained at this time represents the PSS outcome after the 3st Mandala session.
Students who scored 110 or above on the Premenstrual Syndrome Scale (PSS) and met the inclusion criteria of the study were randomly assigned to study groups. The scores obtained by the included students on the PSS were considered as the pre-test for the study.
The Premenstrual Syndrome Scale (PMSS): The PMSS consists of 44 items. The total PMSS score is obtained by summing the scores of subscales. The lowest score that can be obtained on the scale is 44, and the highest score is 220. Higher scores indicate increased severity of PMS symptoms.
Measured: Four days after the third menstrual bleeding.
Premenstrual Syndrome Scale (PMSS) education final test
Premenstrual Syndrome Scale (PMSS): PMSS consists of 44 items. The total PMSS score is obtained by summing the scores of subscales. The lowest score that can be obtained on the scale is 44, and the highest score is 220. Higher scores indicate increased severity of PMS symptoms.
Measured: After the third menstrual bleeding, four days later.
Premenstrual Syndrome Scale (PMSS) control final test
The Premenstrual Syndrome Scale (PMSS): The PMSS consists of 44 items. The total PMSS score is obtained by summing the scores of subscales. The lowest score that can be obtained on the scale is 44, and the highest score is 220. Higher scores indicate increased severity of PMS symptoms.
Measured: After the third menstrual bleeding, four days later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start25 Oct 2023
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- The research employs a pre-test post-test control group design with a randomized controlled semi-experimental approach to determine the impact of education provided for coping with premenstrual syndrome and Mandala activity on premenstrual symptoms.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve SEZER YILDIZ, Bilecik Seyh Edebali Universitesi
- Investigators
- Merve SEZER YILDIZ, Ph.D. Student, Principal investigator, BİLECİK ŞEYH EDEBALİ UNİVERSITYÖzlem ÇAĞAN, Assist. Professor, Study director, ESKİŞEHİR OSMANGAZİ UNİVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176313
- Sponsor's protocol ID
- merve-sezer-yildiz-001
- Acronym
- MANDALA
- Status last verified
- Dec 2023
- First submitted
- 1 Dec 2023
- Last updated
- 19 Dec 2023
- 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 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Training Given to Cope With Premenstrual Syndrome and Mandala Activity on Premenstrual Symptoms
- ClinicalTrials.gov ID
- NCT06176313
- Acronym / sponsor ID
- MANDALA / merve-sezer-yildiz-001
- Conditions
- Premenstrual Syndrome
- Keywords
- premenstrual syndrome, mandala, education, premenstrual symptoms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 19 Dec 2023 (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.
The research employs a pre-test post-test control group design with a randomized controlled semi-experimental approach to determine the impact of education provided for coping with premenstrual syndrome and Mandala activity on premenstrual symptoms.
Research Hypotheses:
H01: Mandala activity is not effective in reducing premenstrual symptoms.
H02: Education provided for coping with premenstrual syndrome is not effective in reducing premenstrual symptoms.
H13: Mandala activity is effective in reducing premenstrual symptoms.
H14: Education provided for coping with premenstrual syndrome is effective in reducing premenstrual symptoms.
H15: Mandala activity is more effective than education provided for coping with premenstrual syndrome in reducing premenstrual symptoms among students with PMS.
Research Groups: Mandala Group, Coping with Premenstrual Symptoms Education Group, and Control Group.
Detailed description
In the conducted international and national literature review, it was observed that various methods are utilized in the management of PMS. Still, no study directly examining the effectiveness of Mandala activity on PMS was found. The literature results provided under the title of Mandala indicate that the activities are predominantly focused on behavioral and psychological conditions. Considering the symptoms of PMS, it is assumed that Mandala activity may have an impact on the behavioral and psychological symptoms of PMS. The assumption of how it might affect the physical symptoms of PMS is also supported by studies indicating that art itself has a therapeutic quality and that the creative process helps individuals develop positive coping methods for the physical discomfort they experience.
The research is planned as a pre-test post-test control group design with a randomized controlled semi-experimental approach, aiming to determine the impact of education on coping with premenstrual syndrome and Mandala activity on premenstrual symptoms
Research Hypotheses:
H01: Mandala activity is not effective in reducing premenstrual symptoms.
H02: Education provided for coping with premenstrual syndrome is not effective in reducing premenstrual symptoms.
H13: Mandala activity is effective in reducing premenstrual symptoms.
H14: Education provided for coping with premenstrual syndrome is effective in reducing premenstrual symptoms.
H15: Mandala activity is more effective than education provided for coping with premenstrual syndrome in reducing premenstrual symptoms among students with PMS.
Research Groups: Mandala Group, Coping with Premenstrual Symptoms Education Group, and Control Group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- The research employs a pre-test post-test control group design with a randomized controlled semi-experimental approach to determine the impact of education provided for coping with premenstrual syndrome and Mandala activity on premenstrual symptoms.
| Arm | Type | Receives |
|---|---|---|
| mandala | Experimental | Other: Mandala Group |
| Coping with Premenstrual Symptoms Education Group | Experimental | Other: Coping with Premenstrual Symptoms Education Group |
| Control Group | Experimental | Other: Control Group |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Age between 18-25 years
- Female students enrolled in the 1st and 2nd years of the Faculty of Health Sciences PMSÖ score of 110 and above
- Regular menstruation in the last six months (between 21-35 days)
- Not using any medication or non-medication methods to cope with PMS symptoms
- Not using contraceptive pills
Key exclusion criteria (0 listed)
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 GroupThe Mandala activity lasts approximately 60 minutes. • A calm environment is provided during the Mandala activity, and participants are ensured not to be disturbed by external stimuli or individuals unless they request assistance. Each student's last menstrual date is recorded in an Excel table. * Two days before the intervention day, students will be contacted and invited to participate in the study. * Monitoring each student's menstrual cycle, the Mandala activity intervention is scheduled during the late luteal phase of each student's menstrual cycle. The intervention is planned within the 5 days before the expected start of menstrual bleeding on days and hours convenient for the student's class schedule. * After each session, on the 4th day of the expected menstrual bleeding, students are subjected to PMSÖ. * On the 4th day of the 4th menstrual period bleeding, the research will be concluded by applying the post-test with PMSÖ to the students." | Other | mandala |
| Coping with Premenstrual Symptoms Education GroupThe education will be conducted through face-to-face interviews in the master's course classroom at the Faculty of Health Sciences at Bilecik Şeyh Edebali University. The education was conducted using PowerPoint presentations projected onto a white smartboard. * One month after the completion of the education, a 1st Reminder training will be provided in the master's course classroom within the Faculty of Health Sciences at Bilecik Şeyh Edebali University, using the face-to-face interview method. * One month after the 1st Reminder training, a 2nd Reminder training will be provided in the master's course classroom within the Faculty of Health Sciences at Bilecik Şeyh Edebali University, using the face-to-face interview method. * On the 4th day of the 4th menstrual period bleeding, the research will be concluded by applying the post-test with PMSÖ to the students. | Other | Coping with Premenstrual Symptoms Education Group |
| Control GroupNo intervention will be applied to the control group throughout the research. However, students in this group who cope with premenstrual syndrome using medication or non-medication methods will be monitored during the three-month menstrual cycle. Each student's menstrual cycle in the control group has been recorded in the Excel table. The estimated end of menstruation for each student has been noted. * At the estimated end of menstruation, the researcher contacts the students in the control group to inquire whether they have used any medication or non-medication methods to cope with premenstrual syndrome. * Those who use medication or non-medication methods to reduce premenstrual symptoms are excluded from the study. * On the 4th day of the 4th menstrual period bleeding, the post-test with PMSÖ will be applied to the students." | Other | Control Group |
Primary outcome
the Premenstrual Syndrome Scale (PSS) for mandala pre-test
Time frame: pre-test
The Premenstrual Syndrome Scale (PMSS): The PMSS consists of 44 items. The total PMSS score is obtained by summing the scores of subscales. The lowest score that can be obtained on the scale is 44, and the highest score is 220. Higher scores indicate increased severity of PMS symptoms.
the Premenstrual Syndrome Scale (PSS) for education pre-test
Time frame: pre-test
The Premenstrual Syndrome Scale (PMSS): The PMSS consists of 44 items. The total PMSS score is obtained by summing the scores of subscales. The lowest score that can be obtained on the scale is 44, and the highest score is 220. Higher scores indicate increased severity of PMS symptoms.
the Premenstrual Syndrome Scale (PSS) for control
Time frame: pre-test
The Premenstrual Syndrome Scale (PMSS): The PMSS consists of 44 items. The total PMSS score is obtained by summing the scores of subscales. The lowest score that can be obtained on the scale is 44, and the highest score is 220. Higher scores indicate increased severity of PMS symptoms.
5 secondary outcomes
the Premenstrual Syndrome Scale (PSS) after mandala-1 session
Time frame: Four days after the first menstrual bleeding.
the Premenstrual Syndrome Scale (PSS) after mandala-2 session
Time frame: Four days after the second menstrual bleeding."
the Premenstrual Syndrome Scale (PSS) after mandala-3 session
Time frame: Four days after the third menstrual bleeding.
Premenstrual Syndrome Scale (PMSS) education final test
Time frame: After the third menstrual bleeding, four days later.
Premenstrual Syndrome Scale (PMSS) control final test
Time frame: After the third menstrual bleeding, four days later.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Premenstrual Syndrome
Not yet recruitingPhase 1
MLS101 Study in PMDD
Premenstrual Dysphoric Disorder ( PMDD), PMDD
Not yet recruiting
Integrated Core Stability Exercises and Yoga Program on Premenstrual Syndrome
Premenstrual Syndrome
Enrolling by invitation
Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Perimenopause
Perimenopause, PMDD
Recruiting
A Clinical Trial to Evaluate the Effects of the Kaia Relief - Cycle System on Premenstrual Symptom Severity, Menstrual Discomfort, and Overall Well-Being in Premenopausal Women.
Premenstrual Syndrome, Menstrual Discomfort
RecruitingObservational study
Occupational Physicians Facing Premenstrual Dysphoric Disorder: Knowledge, Perceptions and Practices in Occupational Health
Premenstrual Dysphoric Disorder (PMDD)
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.
Merve SEZER YILDIZ, Ph.D. Student principal investigator
BİLECİK ŞEYH EDEBALİ UNİVERSITY
Özlem ÇAĞAN, Assist. Professor study director
ESKİŞEHİR OSMANGAZİ UNİVERSITY
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 Group and Coping with Premenstrual Symptoms Education Group in people with Premenstrual Syndrome, run by Eskisehir Osmangazi 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 14 inclusion and 0 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 19 Dec 2023. 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 Merve SEZER YILDIZ, Ph.D. Std. (05301789126, merveyildiz@bilecik.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Premenstrual Syndrome Scale (PSS) for mandala pre-test (time frame: pre-test). The study lists 3 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 19 Dec 2023.