- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07149285
- Original Trial
Effect of Mandala Practice on Menopausal Symptoms and Quality of Life
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Emine Karacan, Asst Prof
- Phone Number: +90 537 214 83 75
- Email: emine.karacan@gibtu.edu.tr
Study Contact Backup
- Name: Emine Karacan, Asst Prof
- Phone Number: +90 5300350414
- Email: emine.karacan@iste.edu.tr
Study Locations
-
-
İskenderun
-
Hatay, İskenderun, Turkey (Türkiye)
- Private Palmiye Hospital, Gynecology and Obstetrics Clinic
-
Contact:
- Emine Karacan, Asst Prof
- Phone Number: +90 537 214 83 75
- Email: emine.karacan@gibtu.edu.tr
-
Contact:
- Emine Karacan, Asst Prof
- Phone Number: +90 530 035 04 14
- Email: emine.karacan@iste.edu.tr
-
Sub-Investigator:
- Emine Karacan, Asst Prof
-
Sub-Investigator:
- Emine Karacan2, Asst Prof
-
Principal Investigator:
- Emine Bakır, Spec Nurse
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- The study included women who met the following conditions:
- Absence of cognitive, hearing, or speech impairments that could interfere with effective communication,
- No physical, psychological, or visual limitations that could hinder participation in mandala coloring activities,
- Literacy in Turkish, including the ability to read, comprehend, and write,
- A confirmed medical diagnosis of menopause,
- Not undergoing any form of psychotherapy or alternative treatment throughout the study period,
- Voluntary participation with signed informed consent.
Exclusion Criteria:
- Participants were excluded from the study if they:
- Provided incomplete or inaccurate responses in the data collection forms,
- Were receiving hormone therapy to manage menopausal symptoms,
- Had a neurological disorder that could impair concentration or communication during the mandala activity,
- Had known allergies to paints or similar substances.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
Intervention Group: Women diagnosed with menopause will be invited to the study through face-to-face interviews at the outpatient clinic.
Information will be provided about the study and the mandala application; women who agree to participate in the study will be asked to fill out an informed consent form, personal information form, menopause symptoms and menopause-specific quality of life assessment scales.
Sample mandalas, blank mandalas, 12 different color crayons and a mandala application follow-up form will be distributed to the participants.
The mandala application will be performed by the participants for 20-30 minutes every day for 15 days.
In the interim periods (every other day), the application will be monitored by phone.
At the end of the 15th day, the participants will be interviewed face-to-face again, the follow-up form will be collected and the menopause symptoms and quality of life scales will be re-administered.
|
Intervention Group: The content of the study and the mandala application will be explained to women diagnosed with menopause, and after obtaining consent, a personal information form and scales regarding menopause symptoms and quality of life will be applied. Participants will be given a sample and blank mandala, 12 colored crayons and a follow-up form. The mandala application will be done for 20-30 minutes every day for 15 days, and will be monitored by phone every other day. At the end of the process, the scales will be re-applied and the follow-up forms will be collected. Their routine treatments will continue. |
|
No Intervention: The control group
The control group will be informed about the study in face-to-face interviews with women who applied to the outpatient clinic and were diagnosed with menopause, and women who agreed to participate in the study will be given an informed consent form, a personal information form, and menopause-specific quality of life and menopause symptom assessment scales and asked to fill them out.
The women will be interviewed again 15 days later and given the menopause-specific quality of life and menopause symptom assessment scales again and asked to fill them out.
In addition, the benefits of the mandala application will be explained to the women in order to eliminate the ethical dilemma, and coloring pencils with mandalas will be given to women who want to do the application.
The women's routine care and treatments will continue during the data collection period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Menopausal Symptoms Assessment Scale (MSAS) total score
Time Frame: Pre-intervention (day 0) and post-intervention (day 15)
|
Evaluation of the effect of mandala practice on the severity of somatic, psychological and urogenital symptoms in menopausal women.
The MSAS consists of 11 items and three subscales.
The subscales are labeled "Somatic Complaints," "Psychological Complaints," and "Urogenital Complaints."
The scale is answered on a 5-point Likert-type scale, with each item scored as follows: 0: None, 1: Mild, 2: Moderate, 3: Severe, and 4: Extremely severe.
The lowest possible score for the entire scale is 0, and the highest is 44.
A higher total score indicates an increase in the severity of the complaints and a negative impact on quality of life.
|
Pre-intervention (day 0) and post-intervention (day 15)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Menopause-Specific Quality of Life Scale (MSQL) total and sub-dimension scores
Time Frame: Pre-intervention (day 0) and post-intervention (day 15)
|
Evaluation of the effect of mandala practice on the quality of life (vasomotor, psychosocial, physical and sexual dimensions) of menopausal women.
The scale consists of four domains: vasomotor, psychosocial, physical, and sexual.
It contains 29 Likert-type statements.
As the score increases, the severity of the complaint and the quality of life decrease.
Because the total scale uses an average score, the lowest possible score is 0, and the highest is 6.
Each subdomain on the MSQL is scored from 0 to 6.
A score of "0" indicates that no problem is experienced.
A score of "1" indicates that the problem exists, but it is not bothersome at all.
Scores between "2 and 6" indicate the severity and increasing severity of the problem.
|
Pre-intervention (day 0) and post-intervention (day 15)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Emine Karacan, Asst Prof, Gaziantep Islamic Science and Technology University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Protocol No:2025/523
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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