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Postpartum DepressionNCT07312812

The Effect of Art-Based Mandala Coloring Activity on Postpartum Anxiety and Postpartum Depression

A study testing Mandala Coloring Activity in people with Postpartum Depression and Postpartum Anxiety, run by Afyonkarahisar Health Sciences University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 49 years, women onlyHealthy volunteers can take part
Conditions the study is for
Postpartum Depression, Postpartum Anxiety
What is being tested?
Mandala Coloring Activity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
15 Jan 2026to 15 Apr 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 49 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Able to speak and understand Turkish
  • Voluntarily agree to participate in the study and have signed the informed consent form
  • 18 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

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Cahide Çevik, PhD contact

+905055189244

cahide.cevik@afsu.edu.tr

About this study

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.

Read more

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.

Read the detailed description

The postpartum period begins approximately one hour after delivery and expulsion of the placenta and lasts for six to eight weeks. This period involves not only physiological recovery but also complex psychosocial processes. Changes in parental responsibilities, family dynamics, self-perception, and body image are key components of the postpartum period. The first year after childbirth is considered a particularly sensitive period for women in terms of both physical and psychological health. This sensitivity arises not only from physical recovery but also from the responsibility of caring for a newborn and the effort required to adapt to psychosocial changes.

Because the majority of maternal deaths occur within the first month postpartum and most neonatal deaths occur during the first month of life, the postpartum period is considered a critical time for maternal and newborn health. Stress, anxiety, fatigue, and reduced self-care experienced during this period, when not adequately managed, may increase the risk of postpartum anxiety and postpartum depression. Postpartum depression not only negatively affects maternal physical and mental health but is also associated with early cessation of breastfeeding, impaired mother-infant bonding, delays in child language and behavioral development, disruptions in childhood vaccination schedules, and adverse health outcomes for the entire family. If left untreated, postpartum depression may lead to long-term negative consequences for mothers, children, and families.

The World Health Organization's postpartum care guidelines emphasize the importance of preventive care, counseling services, mental health assessment, family planning, and physical evaluation of both the mother and the infant during the first six weeks postpartum. Counseling topics include breastfeeding, umbilical cord care, emotional well-being, screening for postpartum depression, assessment of domestic violence risk, nutrition, hygiene, safe sexual practices, exercise, iron and folic acid supplementation, and psychosocial support. Despite these recommendations, significant gaps remain in the provision of mental health services during the postpartum transition period, and systematic evaluation of maternal emotional well-being by health professionals is often insufficient. This highlights the need for supportive, non-pharmacological interventions during the postpartum period.

Stress, metabolic changes, and hormonal fluctuations during pregnancy and the postpartum period may increase anxiety levels and contribute to the development of postpartum depression, which is the most common psychiatric disorder following childbirth. Postpartum depression affects not only maternal health but also child development and parenting behaviors. When untreated, it can have profound and lasting negative effects on mothers, children, and families. Early identification of postpartum mental health problems and the implementation of supportive interventions are therefore of critical importance.

Mandala is an art form known to promote psychological relaxation and is typically composed of circular or geometric patterns. Mandalas may be used as a meditation tool and help direct attention to the present moment. Carl Gustav Jung described mandala techniques as therapeutic tools that reflect the individual's inner world and support psychological balance. Mandala practices are generally categorized as unstructured mandalas, which involve free drawing within a circle, and structured mandalas, which involve coloring predefined patterns. Structured mandala coloring is considered an art-based therapeutic approach that enhances attention, mindfulness, and emotional regulation. Although previous studies have demonstrated positive effects of mandala coloring on stress, anxiety, and emotional well-being, research examining its effects on postpartum anxiety and postpartum depression among postpartum women is limited. Therefore, this study aims to investigate the effects of a structured mandala coloring activity on postpartum anxiety and postpartum depression.

This study is designed as a randomized controlled experimental trial and will be conducted at Afyonkarahisar Health Sciences University Health Practice and Research Center, Obstetrics and Gynecology Clinic. The study population will consist of women who give birth at the clinic. Eligible participants will include women who are able to speak and understand Turkish, are 18 years of age or older, are literate, voluntarily agree to participate in the study, and provide written informed consent. Additional inclusion criteria include having no diagnosed psychiatric disorder, not currently receiving psychological or psychiatric support (therapy, counseling, or medication), experiencing no maternal complications during delivery, and having a newborn without congenital malformations, anomalies, or complications. Exclusion criteria include a history of psychological or psychiatric treatment or receiving such treatment during the data collection period, the presence of serious neurological or psychiatric disorders affecting cognitive function, severe health conditions that impair communication or participation in the study, failure to provide informed consent, inability to speak or understand Turkish, and the presence of maternal or neonatal complications during delivery.

Sample size was calculated using G*Power software version 3.1.9.7. Because no previous studies were identified that simultaneously evaluated the effects of mandala art on postpartum anxiety and postpartum depression, effect size estimation was not possible. Therefore, a moderate effect size (f = 0.25), as recommended by Cohen for F-test-based power analysis, was used. The power analysis was conducted with a significance level of α = 0.05 and statistical power of 95% (1-β = 0.95). Based on this analysis, a minimum of 22 participants per group was required. Considering the presence of multiple measurement time points and the time-consuming nature of the data collection process, the sample size was increased to compensate for potential data loss. Accordingly, a total of 60 women, with 30 participants in the intervention group and 30 participants in the control group, were planned to be included in the study.

Participants will be randomized into intervention and control groups using a lottery method. Considering that approximately 30 births occur weekly at the study site, participant selection will be conducted five days per week to prevent scheduling conflicts and ensure feasibility of follow-up. On each recruitment day, women who give birth and meet the inclusion criteria will be assigned to either the intervention or control group. After group allocation, participants will receive detailed information about the study, and the telephone numbers of those who consent to participate will be recorded. Within the hospital setting, only participant selection and mandala training will be conducted, and no additional interventions will be applied.

Participants in the intervention group will receive individual mandala coloring training before hospital discharge. The training will last approximately 20 minutes and will consist of three stages. In the first stage, participants will receive information about mandala coloring. In the second stage, a trained researcher with certification in mandala art will demonstrate the coloring process using a sample mandala. In the third stage, participants will complete a brief practice session on a sample mandala. Following the training, participants will be provided with a mandala coloring set for home use. Participants in the intervention group will be followed for eight weeks, with weekly telephone contacts. During the first contact, a 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, and participants will be asked to share photographs of their completed mandala work via a messaging application.

During telephone follow-ups, individualized counseling will be provided based on participants' needs and questions. Although the counseling will not follow a standardized format, it may include topics such as maternal perineal hygiene, nutrition, breastfeeding, breast care, and basic infant care practices. Postpartum anxiety and postpartum depression scales will be administered at the 1st, 4th, and 8th weeks of the study.

Participants in the control group will not receive any intervention and will continue to receive routine postpartum care. Data from the control group will be collected via telephone at the same time points as the intervention group.

Ethical approval for this study has been obtained. All study procedures will be conducted in accordance with ethical principles governing research involving human participants. Participant confidentiality will be maintained, data will be kept confidential, and participation will be entirely voluntary. Participants will have the right to withdraw from the study at any time without consequences.

Being tested
Mandala Coloring Activity
Keywords
woman, postpartum, depression, anxiety, mandala
Medical subject headings
Depression, Postpartum, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mandala Coloring ActivityBehavioural

    Structured mandala coloring training and home practice.

Study groups in NCT07312812
Study groupRoleWhat they receive
Mandala Coloring Activity GroupExperimentalWomen 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
Receives: Behavioral: Mandala Coloring Activity
Standard of care groupNo interventionWomen 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, week 4, and week 8

Secondary outcomes (1)
  1. Postpartum Anxiety

    Change in postpartum anxiety level measured by the Postpartum Anxiety Scale.The original version of the scale was developed and validated with mothers who have infants aged 0-6 months. The scale has the following subdimensions: maternal skills and attachment, newborn well-being and safety, infant care practices, and psychosocial adjustment to motherhood. The maximum possible score that can be obtained from the Likert-type scale is 176, and the cut-off score is 113.5. Higher scores on the scale indicate higher levels of anxiety symptoms.

    Measured: Baseline, week 4, and week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2025
  2. Study start15 Jan 2026 (estimated)
  3. Primary completion15 Apr 2026 (estimated)
  4. Study completion15 Apr 2026 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07312812
Sponsor's protocol ID
AFYON-HSU-MANDALA-2025
Status last verified
Dec 2025
First submitted
17 Dec 2025
Last updated
7 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data could be shared in anonymized form; however, no formal data sharing plan has been established for this study.

Questions about this trial

What is this clinical trial studying?

A study testing Mandala Coloring Activity in people with Postpartum Depression and Postpartum Anxiety, run by Afyonkarahisar Health Sciences University.

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 8 inclusion and 8 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: opening soon, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cahide Çevik, PhD (+905055189244, cahide.cevik@afsu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postpartum Depression (time frame: Baseline, week 4, and week 8). 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 7 Jan 2026.

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