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

To reduce pregnancy-related anxiety

Randomization: Eligible pregnant women attending the prenatal clinic will be consecutively sampled. After pretest and informed consent, participants will be allocated 1:1 to experimental or control groups using block randomization with block sizes of four and six. Allocation sequences will be generated from possible block combinations (e.g., AABB, ABAB, ABBA, BAAB, BABA, BBAA) to maintain balance between groups. The intervention and control groups run in parallel. There is no blinding. It is randomized.

This study will be conducted at the prenatal care clinic of Al-Zahra Educational, Therapeutic, and Research Center in Rasht. For the intervention group, six mandala designs and colored pencils will be provided, and participants will be asked to focus on coloring—completing one design per day for six consecutive days—for at least 30 minutes each session in a quiet environment. The control group will color simple shapes, and both groups will receive routine prenatal care. Post-tests will be administered to both groups immediately after the six-day period and again one month later.

In: Signed consent Out: Acute crisis or suicidal ideation

Intervention: mandala coloring (one design/day, 6 consecutive days, ≥30 min/session, quiet setting). Control: simple-shape coloring. Both: routine prenatal care. Post-tests: after 6 days and 1 month.

Pregnancy-related anxiety,

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.

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.

Access will begin 6 months after publication of the main results and will remain available for 5 years.

Qualified researchers from academic, non-profit, and governmental institutions, as well as researchers from industry, may request access.

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.

Requests should be sent to the Data Access Committee at Guilan university of medical sciences

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.