Mandala Coloring, Stress, and Anxiety

NCT07726186 | Not Yet Recruiting DMC

• 1 other identifier: 2026/17
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

\*\*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.

Conditions

Anxiety; Perceived Stress; High-risk Pregnancy

Outcome Measures

Primary Outcomes (2)

• Perceived Stress Score (Neuman Systems Model-Based Perceived Stress Scale in High-Risk Pregnancy [NSM-HRPPSS])

  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])

  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)

Study Arms (2)

Mandala Coloring Activity Group

EXPERIMENTAL

Other: Mandala Coloring Activity Group

Control Group

OTHER

Other: Control Group

Interventions

Control Group OTHER

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.

Control Group

Mandala Coloring Activity Group OTHER

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

Mandala Coloring Activity Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Fatma Keskin Töre

CONTACT

0 344 300 26 06; keskinfatma989@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOCIATE PROFESSOR

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 24, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share