Mandala Coloring, Stress, and Anxiety

July 20, 2026 updated by: Fatma Keskin Töre, Kahramanmaras Sutcu Imam University

Effects of Mandala Coloring Activity on Perceived Stress and Anxiety in Women With High-Risk Pregnancies

**Abstract**

Although pregnancy is a physiological process, it also involves various risks that may threaten the health of both the mother and fetus. Complications arising in high-risk pregnancies and prolonged bed rest increase stress and anxiety levels in women, negatively affecting both physical and psychological well-being. Failure to recognize or appropriately manage these adverse conditions may lead to serious perinatal outcomes such as preterm birth, low birth weight, depression, and difficulties in mother-infant bonding, thereby creating an additional burden on both maternal-infant health and the healthcare system.

This proposed project aims to examine the effect of mandala coloring activity on perceived stress and anxiety in women with high-risk pregnancies. The study will be conducted as a randomized controlled experimental study with a pretest-posttest design. The population of the study will consist of pregnant women hospitalized in the Obstetrics and Gynecology service of Kahramanmaraş Sütçü İmam University Health Practice and Research Hospital. Based on power analysis, with a significance level of α = 0.05 and statistical power of (1-β) = 0.80, at least 26 participants per group were required assuming a large effect size (Cohen's d ≈ 0.80). Considering potential sample loss, 30 participants were planned for each group, resulting in a total sample size of 60.

Before data collection, ethics committee approval and institutional permission will be obtained. Data will be collected using the Personal Information Form, the Perceived Stress Scale in Risky Pregnancies Based on the Neuman Systems Model, and the State Anxiety Inventory. Pregnant women in the experimental group will participate in mandala coloring once daily for three consecutive days. Stress and anxiety levels will be assessed before and after the intervention using the relevant scales. In addition to descriptive statistical methods, appropriate statistical tests will be used according to normality assumptions. The methods specified in the project will be carried out by the principal investigator under the supervision of the advisor.

The project is expected to demonstrate that mandala coloring is effective in reducing stress and anxiety in women with high-risk pregnancies. In line with the goals emphasized in Türkiye's 12th Development Plan regarding innovative healthcare practices and strengthening public health, the findings are expected to contribute to the protection of maternal and infant health and the promotion of psychological well-being. Furthermore, by supporting reductions in medication use, length of hospital stay, and healthcare costs, the project may contribute to the dissemination of cost-effective, accessible, and holistic care approaches within the healthcare system.

Mandala coloring is an easily applicable, side-effect-free, and low-cost method that does not require special equipment, technical expertise, or a professional art therapist. In this respect, it represents a sustainable non-pharmacological intervention that can be easily implemented by nurses in both hospital settings and community-based healthcare services, with almost no training or material costs. Therefore, the findings of this project are expected to support not only individual-level psychological relaxation but also the development of cost-effective, innovative, and accessible care models in healthcare services. The project outcomes are also expected to strengthen the holistic care approach in nursing and promote the integration of non-pharmacological interventions into clinical protocols.

The findings of the study will be published in scientific journals and presented at national and international congresses. In addition, this research will contribute to the literature and provide a basis for the development of more comprehensive future projects. One of the most important outcomes of this research is that it will enable an undergraduate student to gain experience in conducting research, interpreting results, and preparing for publication, thereby contributing to the training of qualified researchers in priority areas of our country.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Aged 18 years or older
  • Able to read, write, and communicate in Turkish
  • Singleton pregnancy
  • Hospitalized with a diagnosis of a high-risk pregnancy (e.g., threatened preterm labor, gestational hypertension, mild preeclampsia, gestational diabetes mellitus, intrauterine growth restriction (IUGR), oligohydramnios, stable premature rupture of membranes risk [excluding PPROM], maternal obesity, etc.)
  • Planned hospitalization of at least 3 days to ensure completion of the intervention
  • Between 20 and 36 weeks of gestation

Exclusion Criteria:

  • Presence of a fetal anomaly or fetal distress
  • Gestational age below 20 weeks or above 36 weeks
  • Imminent delivery or active labor
  • Communication difficulties (e.g., hearing or visual impairment, or inability to communicate effectively in Turkish)
  • Diagnosis of a psychiatric disorder
  • Previous participation in similar psychosocial or mind-body interventions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Control Group
Other: Control Group

Pregnant women in the control group will receive standard hospital care. At baseline (pretest), participants will complete the Personal Information Form, the Perceived Stress Scale in High-Risk Pregnancies Based on the Neuman Systems Model, and the State Anxiety Inventory, which will be administered by the researcher.

After completion of the study period (on the third day), participants in the control group will again complete the Perceived Stress Scale in High-Risk Pregnancies Based on the Neuman Systems Model and the State Anxiety Inventory, administered by the researcher as the posttest assessment.
Experimental: Mandala Coloring Activity Group
Other: Mandala Coloring Activity Group
Previous studies investigating the effects of art therapy on reducing psychological symptoms have demonstrated that the use of circular patterns is more effective in symptom management. Accordingly, ready-made circular mandala coloring templates will be used in this study. To maintain participants' interest and motivation, the duration of the intervention has been determined based on previous similar studies. The literature suggests that brief, repeated sessions are more effective in sustaining attention and promoting psychological relaxation, whereas prolonged sessions may reduce participants' engagement. Therefore, mandala coloring sessions will be conducted over three consecutive days, with the intervention lasting no longer than one week. Participants will complete one session per day, for a total of three sessions. During each session, different mandala templates will be provided, and participants will be allowed to choose the design they prefe

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Perceived Stress Score (Neuman Systems Model-Based Perceived Stress Scale in High-Risk Pregnancy [NSM-HRPPSS])
Time Frame: Baseline (Day 1) and Day 3 (post-intervention)
The Perceived Stress Scale-10 (PSS-10) will be used to assess the degree to which individuals perceive situations in their lives as stressful. The scale consists of 10 items rated on a 5-point Likert scale (0 = never to 4 = very often). Total scores range from 0 to 40, with higher scores indicating higher levels of perceived stress.
Baseline (Day 1) and Day 3 (post-intervention)
State Anxiety Score (State Anxiety Inventory [SAI])
Time Frame: Baseline (Day 1) and Day 3 (post-intervention)
The State Anxiety Inventory (SAI), the state subscale of the State-Trait Anxiety Inventory, will be used to assess participants' current level of anxiety. The scale consists of 20 items rated on a 4-point Likert scale. Total scores range from 20 to 80, with higher scores indicating higher levels of state anxiety.
Baseline (Day 1) and Day 3 (post-intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kahramanmaras Sutcu Imam University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026/17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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