NCT07312812

Brief Summary

The postpartum period is a critical time for women's physical and psychological health, during which significant hormonal, emotional, and social changes occur. During this period, many women experience increased stress, anxiety, and emotional vulnerability while adapting to new parental responsibilities and caring for a newborn. When these challenges are not adequately managed, they may contribute to the development of postpartum anxiety and postpartum depression, which can negatively affect maternal well-being, mother-infant bonding, breastfeeding practices, and child development. Despite the importance of postpartum mental health, non-pharmacological and easily accessible supportive interventions remain limited. This randomized controlled experimental study aims to evaluate the effect of a structured, art-based mandala coloring activity on postpartum anxiety and postpartum depression among postpartum women. The study will be conducted at Afyonkarahisar Health Sciences University Health Practice and Research Center, Obstetrics and Gynecology Clinic, and will include women who have recently given birth at this institution. Eligible participants will be randomly assigned to either an intervention group or a control group. Women in the intervention group will receive individual training in mandala coloring before hospital discharge and will be provided with mandala coloring materials for home use. They will be encouraged to engage in the mandala coloring activity over an eight-week period and will be followed through regular telephone contacts. In addition to monitoring participation in the activity, individualized supportive counseling will be provided based on participants' needs. Women in the control group will receive routine postpartum care without any additional intervention. Postpartum anxiety and postpartum depression levels will be assessed at multiple time points during the study to examine changes over time. This study seeks to determine whether mandala coloring, as a low-cost and non-pharmacological art-based activity, may serve as a supportive approach to improve psychological well-being during the postpartum period. The findings may contribute to the development of accessible interventions aimed at supporting maternal mental health in the early postpartum period.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 31, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

January 15, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
Last Updated

January 7, 2026

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

December 17, 2025

Last Update Submit

January 3, 2026

Conditions

Keywords

womanpostpartumdepressionanxietymandala

Outcome Measures

Primary Outcomes (1)

  • Postpartum Depression

    Change in postpartum depression level measured by the Edinburgh Postnatal Depression Scale (EPDS). This scale was developed to determine whether there is a risk of depression in mothers during the postpartum period . The scale consists of 10 items in a four-point Likert format scored between 0 and 3. The minimum score that can be obtained from the scale is 0 and the maximum score is 30. The cut-off score of the scale is 13. Scores above this value indicate a high risk of depression.

    Baseline, week 4, and week 8

Secondary Outcomes (1)

  • Postpartum Anxiety

    Baseline, week 4, and week 8

Study Arms (2)

Mandala Coloring Activity Group

EXPERIMENTAL

Women who agree to participate in the study will receive individual mandala coloring training by the researcher before hospital discharge. The training will last approximately 20 minutes and will consist of three stages. In the first stage, participants will be informed about mandala coloring. In the second stage, an assistant researcher will demonstrate the coloring process using a sample mandala. The participant will then perform a brief practice on a small sample mandala. In the third stage, a mandala coloring set will be provided for participants to use at home. Following the training, participants will be followed for eight weeks with weekly telephone contacts. The first telephone contact will take place during the first week. During this contact, the personal information form and the postpartum anxiety and postpartum depression scales will be administered to collect baseline data. In subsequent contacts, the frequency and duration of mandala coloring activities will be assessed

Behavioral: Mandala Coloring Activity

Standard of care group

NO INTERVENTION

Women in the control group will not receive any intervention. However, postpartum anxiety and postpartum depression scales will be administered by telephone at weeks 1, 4, and 8. During the first week, demographic information will also be collected using a personal information form.

Interventions

Structured mandala coloring training and home practice.

Mandala Coloring Activity Group

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsEligibility is limited to women in the postpartum period who have given birth.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Able to speak and understand Turkish
  • Voluntarily agree to participate in the study and have signed the informed consent form
  • years of age or older
  • Literate
  • Have not received any psychiatric diagnosis and are not currently receiving psychological or psychiatric support (therapy, counseling, or medication treatment)
  • Have not experienced any complications during delivery
  • Have a newborn with no malformation or anomaly
  • Have a newborn with no complications

You may not qualify if:

  • Have previously received psychological or psychiatric treatment or are receiving such treatment during the data collection period,
  • Have a serious neurological or psychiatric disorder that affects cognitive functioning,
  • Have serious health problems that prevent communication or participation in the study,
  • Have not provided informed consent,
  • Are unable to speak or understand Turkish,
  • Have experienced complications during delivery,
  • Have a newborn with a malformation or anomaly,
  • Have a newborn with any complications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Depression, PostpartumDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Central Study Contacts

Cahide Çevik, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This study uses a randomized, parallel-group interventional design. Eligible postpartum women are randomly assigned to either an intervention group or a control group using a lottery-based randomization method. The two groups are followed concurrently throughout the study period without crossover between groups. Participants in the intervention group receive a structured, art-based mandala coloring intervention in addition to routine postpartum care, while participants in the control group receive routine postpartum care only. Outcomes are assessed at multiple predefined time points to evaluate changes over time and to compare the effects of the intervention between groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Public health Nursing

Study Record Dates

First Submitted

December 17, 2025

First Posted

December 31, 2025

Study Start

January 15, 2026

Primary Completion

April 15, 2026

Study Completion

April 15, 2026

Last Updated

January 7, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Individual participant data could be shared in anonymized form; however, no formal data sharing plan has been established for this study.