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.
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.
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.
- Conditions
- High-risk Pregnancy, Perceived Stress, Anxiety
- 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 group | Role | What they receive |
|---|---|---|
| Mandala Coloring Activity Group | Experimental | Not described Receives: Other: Mandala Coloring Activity Group |
| Control Group | Other | Not described Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted24 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-risk PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Keskin Töre, Kahramanmaras Sutcu Imam University
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mandala Coloring Activity on Perceived Stress and Anxiety in Women With High-Risk Pregnancies
- ClinicalTrials.gov ID
- NCT07726186
- Acronym / sponsor ID
- 2026/17
- Conditions
- High-risk Pregnancy, Perceived Stress, Anxiety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mandala Coloring Activity Group | Experimental | Other: Mandala Coloring Activity Group |
| Control Group | Other | Other: Control Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mandala Coloring Activity GroupPrevious 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 | Other | Mandala Coloring Activity Group |
| Control GroupPregnant 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. | Other | Control Group |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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.