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Not yet recruiting NCT07726186

Mandala Coloring, Stress, and Anxiety

No phase Interventional High-risk Pregnancy Perceived Stress Anxiety

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mandala Coloring Activity Group, Control Group.
Who it may be relevant to
Registry conditions: High-risk Pregnancy, Perceived Stress, Anxiety. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

\*\*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.

Interventions

  • 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
  • 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 Neu

Primary outcome measures

  • 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)]
  • State Anxiety Score (State Anxiety Inventory [SAI]) [Time frame: Baseline (Day 1) and Day 3 (post-intervention)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07726186 · 2026/17

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗