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High-risk PregnancyNCT07726186

Mandala Coloring, Stress, and Anxiety

A study testing Mandala Coloring Activity Group in people with High-risk Pregnancy and Perceived Stress, run by Kahramanmaras Sutcu Imam 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

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… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
High-risk Pregnancy, Perceived Stress, Anxiety
What is being tested?
Mandala Coloring Activity Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
1 Aug 2026to 30 Dec 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 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

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

Fatma Keskin Töre contact

0 344 300 26 06

keskinfatma989@gmail.com

About this study

Official title: 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.

Read more

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.

Being tested
Mandala Coloring Activity Group, Control Group
Medical subject headings
Anxiety Disorders

What participants receive

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

  • Mandala Coloring Activity GroupOther

    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

  • Control GroupOther

    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.

Study groups in NCT07726186
Study groupRoleWhat they receive
Mandala Coloring Activity GroupExperimentalNot described
Receives: Other: Mandala Coloring Activity Group
Control GroupOtherNot described
Receives: Other: Control Group

What is being measured

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

  1. 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.

    Measured: Baseline (Day 1) and Day 3 (post-intervention)

  2. 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.

    Measured: Baseline (Day 1) and Day 3 (post-intervention)

Timeline

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

  1. First posted24 Jul 2026
  2. Study start1 Aug 2026 (estimated)
  3. Primary completion1 Nov 2026 (estimated)
  4. Study completion30 Dec 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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07726186
Sponsor's protocol ID
2026/17
Status last verified
Jul 2026
First submitted
6 Jul 2026
Last updated
24 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Mandala Coloring Activity Group in people with High-risk Pregnancy and Perceived Stress, run by Kahramanmaras Sutcu Imam 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 6 inclusion and 6 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 24 Jul 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 Fatma Keskin Töre (0 344 300 26 06, keskinfatma989@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. 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 24 Jul 2026.

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