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IRCT20261010071368N1 IRCT 2026-11-05 Rasht University of Medical Sciences The Effect of Mandala Coloring on Antenatal Anxiety in Women Referring to Al-Zahra Educational, Medical and Research Center of Rasht: A Randomized Placebo-Controlled Clinical Trial The Effect of Mandala Coloring on Antenatal Anxiety in Women Referring to Al-Zahra Educational, Medical and Research Center of Rasht: A Randomized Placebo-Controlled Clinical Trial 2026-11-16 anticipated 80 Pending https://irct.ir/trial/93950 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization Method Consecutive sampling will be conducted among eligible pregnant women visiting the prenatal care clinic. Following the completion of the pre-test and obtaining informed consent, participants will be assigned to either the experimental or control group at a 1:1 ratio using block randomization with varying block sizes of four and six. The allocation sequence will be generated using all possible block combinations (e.g., AABB, ABAB, ABBA, BAAB, BABA, and BBAA) to maintain a balanced number of participants across the two groups throughout the study. Random Allocation Sequence Generation Method The random sequence will be generated using the Sealed Envelope™ online system. This system will create the allocation list based on block sizes of four and six and a 1:1 allocation ratio, utilizing a random number generation algorithm. Allocation Concealment Method To prevent selection bias, the allocation sequence will be generated by an individual independent of the sampling and data collection processes. Each participant's allocation assignment will be placed inside a sequentially numbered, opaque, and sealed envelope (SNOSE). Following the confirmation of eligibility criteria, obtaining informed consent, and the completion of pre-test questionnaires, the researcher will open the envelope corresponding to the next participant to reveal the assigned group. Consequently, prior to the opening of the envelope, neither the researcher responsible for participant recruitment nor the participants themselves will be aware of the assigned group. N/A Pregnancy-related anxiety. Intervention 1: Intervention group: For the intervention group, six mandala designs and colored pencils are provided, and participants are asked to focus on coloring in a quiet environment for six consecutive days completing one design per day for at least 30 minutes each time. Intervention 2: Control group: The control group involves coloring simple shapes distinct from a mandala structure at a rate of one design per day for six days. Yes - There is a plan to make this available What will be shared: De-identified individual participant data (IPD) and the related data dictionary from the randomized clinical trial. The shared data include demographic variables, intervention assignment, primary and secondary outcomes, and safety variables. All direct identifiers will be removed before sharing. When: Access will begin 6 months after publication of the main results and will remain available for 5 years. To whom: Qualified researchers from academic, non-profit, and governmental institutions, as well as researchers from industry, may request access. Conditions: Data may be used for secondary research, validation of results, or meta-analysis. Use is conditional on approval of a research proposal, ethics committee approval, and a signed data-use agreement. Commercial use is not permitted without prior written consent. Where to obtain: Requests should be sent to the Data Access Committee at Guilan university of medical sciences How to obtain: 1. Applicant submits a research proposal and data-use agreement. 2. The Data Access Committee reviews the request within 4 weeks. 3. If approved, the applicant signs the data-use agreement and provides ethics approval. 4. Data are transferred securely within 2 weeks after all documents are complete. Total time: approximately 6–8 weeks. Comments:
public Fatemeh Rezaei Kermajanei
Daneshju Street, Shahid Beheshti Highway, Rasht
Rasht Iran (Islamic Republic of) 41469-39814 +98 918 137 0523 fatemeh.rezaei0523@gmail.com Rasht University of Medical Sciences scientific Fatemeh Rezaei Kermajanei
Rasht – Shahid Beheshti Highway – Daneshju Street
Rasht Iran (Islamic Republic of) 41469-39814 +98 918 137 0523 fatemeh.rezaei0523@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) - Willingness to participate in the study and sign a written informed consent form; - Iranian citizenship; - Ability to communicate and speak in Persian;- Basic literacy (ability to read and write); - Gestational age of 28 to 32 weeks based on the first day of the last menstrual period and/or a valid ultrasound (third trimester); - Singleton, low-risk pregnancy as documented in prenatal care records and confirmed by a physician or midwife; - No history of spontaneous abortion, induced abortion, or stillbirth - Absence of underlying medical conditions or known pregnancy complications at study entry (including pre-gestational diabetes, chronic hypertension, pre-eclampsia, heart disease, or known fetal anomalies); - No history of severe psychiatric disorders (such as psychotic disorders or bipolar disorder); - Not currently taking psychiatric medications, antidepressants, or anti-anxiety drugs at study entry; - No history of delivering an infant with a disability or congenital anomaly; - Access to a smartphone and the ability to use a messaging app to receive educational materials, submit photos of completed coloring pages, and participate in study follow-ups. no limit no limit Female Severe visual impairment or color blindness Severe motor disability in hands Acute psychiatric crisis or suicidal ideation Severe hearing or speech impairment F41.9 Anxiety disorder, unspecified N/A N/A Intervention group: For the intervention group, six mandala designs and colored pencils are provided, and participants are asked to focus on coloring in a quiet environment for six consecutive days completing one design per day for at least 30 minutes each time. Control group: The control group involves coloring simple shapes distinct from a mandala structure at a rate of one design per day for six days. Pregnancy-related anxiety,. Timepoint: Before, immediately after, and one month after the intervention. Method of measurement: Pregnancy-Related Anxiety Questionnaire. Rasht University of Medical Sciences Approved 2026-10-10 Ethics Committee of Guilan University of Medical Sciences Rasht – Shahid Beheshti Highway – Daneshju Street Rasht Guilan Iran (Islamic Republic of)