High-risk Nulliparous Pregnancy, Patients Scheduled for Cesarean Section, Surgical Fear, Preoperative Anxiety, and Cortisol LevelNCT07691320
The Effect of Mandala Art Therapy on Surgical Fear and the Stress Hormone (Cortisol) in High-risk Pregnant Women Before Cesarean Section.
A study testing Mandala Art Therapy in people with High-risk Nulliparous Pregnancy, Patients Scheduled for Cesarean Section, Surgical Fear, Preoperative Anxiety, and Cortisol Level, run by Inonu University.
Trial summary
This randomized controlled study aims to evaluate the effect of mandala art therapy applied before cesarean section on surgical fear and cortisol levels in high-risk pregnant women. Participants will be randomly assigned to intervention and control groups. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- High-risk Nulliparous Pregnancy, Patients Scheduled for Cesarean Section, Surgical Fear, Preoperative Anxiety, and Cortisol Level
- What is being tested?
- Mandala Art Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 1 Aug 2027
- 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- The study sample will consist of high-risk nulliparous women scheduled for elective cesarean section on the same day. Participants will be included if they are 18 years of age or older, diagnosed with high-risk pregnancy conditions (e.g., preeclampsia, gestational diabetes, placenta previa, oligohydramnios, etc.), at term pregnancy (37-42 weeks gestation), with a singleton pregnancy, and able to understand and complete the data collection forms.
Who cannot join
- Women with a diagnosed psychiatric disorder, any condition that impairs communication (such as hearing, visual, or language impairments), those receiving systemic corticosteroid therapy, those with endocrine disorders that may affect cortisol levels, and those with active oral lesions such as aphthous ulcers or other oral mucosal lesions will be excluded from the study.
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: The Effect of Mandala Art Therapy Applied Before Cesarean Section on Surgical Fear and Cortisol Levels in High-Risk Nulliparous Women: A Randomized Controlled Trial
This randomized controlled study aims to evaluate the effect of mandala art therapy applied before cesarean section on surgical fear and cortisol levels in high-risk pregnant women. Participants will be randomly assigned to intervention and control groups. The intervention group will receive mandala art therapy prior to surgery, while the control group will receive standard care. Surgical fear levels and salivary cortisol levels will be measured to assess the outcomes.
Read the detailed description
This randomized controlled trial is designed to investigate the effect of mandala art therapy applied in the preoperative period on surgical fear and cortisol levels in high-risk nulliparous women scheduled for cesarean section. The study will be conducted with participants meeting inclusion criteria and randomly assigned to intervention and control groups using a randomization method.
The intervention group will receive a structured mandala art therapy session prior to cesarean section, while the control group will receive routine preoperative care. Surgical fear levels will be assessed using a validated scale, and physiological stress will be evaluated through salivary cortisol measurements. The primary outcome of the study is the change in surgical fear levels, while the secondary outcome is the change in cortisol levels. Data will be analyzed using appropriate statistical methods to determine the effectiveness of the intervention.
- Being tested
- Mandala Art Therapy
- Keywords
- Cortisol, Surgical Fear, Cesarean
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandala Art TherapyBehavioural
Participants allocated to the intervention group will receive mandala art therapy in addition to standard preoperative care before cesarean section. The intervention will consist of a single structured mandala coloring session lasting approximately 30-45 minutes and will be administered prior to surgery. The intervention is intended to reduce preoperative surgical fear and psychological stress.
| Study group | Role | What they receive |
|---|---|---|
| Mandala Art Therapy Group | Experimental | Participants allocated to the intervention group will receive mandala art therapy in addition to standard preoperative care before cesarean section. The intervention will consist of a single structured mandala coloring session lasting approximately 30-45 minutes and will be administered prior to surgery. The intervention is intended to reduce preoperative surgical fear and psychological stress. Receives: Behavioral: Mandala Art Therapy |
| Control Group | No intervention | Pregnant women in this group will receive routine preoperative care without mandala art therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Fear
Surgical fear will be measured using a validated surgical fear scale in high-risk nulliparous women undergoing cesarean section.
Measured: Baseline (before intervention) and immediately prior to cesarean section
Secondary outcomes (1)
Salivary Cortisol Level
Salivary cortisol levels will be measured as a physiological indicator of stress in high-risk nulliparous women undergoing cesarean section.
Measured: Baseline and immediately prior to cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High-risk Nulliparous Pregnancy, Patients Scheduled for Cesarean Section, Surgical Fear, Preoperative Anxiety, and Cortisol LevelStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- 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
- Model description
- This study is a parallel-group randomized controlled trial with two arms: intervention and control. Participants will be randomly assigned to either the mandala art therapy group or the standard care group. The intervention will be applied in the preoperative period before cesarean section. Outcomes will be assessed using surgical fear scale and salivary cortisol measurements.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Melike TAN ÇELİK, Inonu University
- Investigators
- Ercan Yılmaz, Professor, Study director, Inonu University Turgut Ozal Medical CenterEsra GÜNEY, Associate Professor, Principal investigator, İnönü University Faculty of Health SciencesMelike Tan, Midwife, Study director, İnönü University Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07691320
- Sponsor's protocol ID
- 10069
- Status last verified
- Jul 2026
- First submitted
- 13 Jun 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: research result will be shared
Publications
Okyay EK, Guney E, Coban M. The Effect of Mandala Art Therapy on Anxiety, Mood, and Plasma Glucose Levels in Pregnant Women with Abnormal OGTT Values: A Randomized Controlled Study. Z Geburtshilfe Neonatol. 2025 Dec;229(6):436-445. doi: 10.1055/a-2586-3747. Epub 2025 May 23.
PubMed 40409274
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mandala Art Therapy Applied Before Cesarean Section on Surgical Fear and Cortisol Levels in High-Risk Nulliparous Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07691320
- Acronym / sponsor ID
- 10069
- Keywords
- Cortisol, Surgical Fear, Cesarean
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 8 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.
This randomized controlled study aims to evaluate the effect of mandala art therapy applied before cesarean section on surgical fear and cortisol levels in high-risk pregnant women. Participants will be randomly assigned to intervention and control groups. The intervention group will receive mandala art therapy prior to surgery, while the control group will receive standard care. Surgical fear levels and salivary cortisol levels will be measured to assess the outcomes.
Detailed description
This randomized controlled trial is designed to investigate the effect of mandala art therapy applied in the preoperative period on surgical fear and cortisol levels in high-risk nulliparous women scheduled for cesarean section. The study will be conducted with participants meeting inclusion criteria and randomly assigned to intervention and control groups using a randomization method.
The intervention group will receive a structured mandala art therapy session prior to cesarean section, while the control group will receive routine preoperative care. Surgical fear levels will be assessed using a validated scale, and physiological stress will be evaluated through salivary cortisol measurements. The primary outcome of the study is the change in surgical fear levels, while the secondary outcome is the change in cortisol levels. Data will be analyzed using appropriate statistical methods to determine the effectiveness of the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a parallel-group randomized controlled trial with two arms: intervention and control. Participants will be randomly assigned to either the mandala art therapy group or the standard care group. The intervention will be applied in the preoperative period before cesarean section. Outcomes will be assessed using surgical fear scale and salivary cortisol measurements.
| Arm | Type | Receives |
|---|---|---|
| Mandala Art Therapy Group | Experimental | Behavioral: Mandala Art TherapyParticipants allocated to the intervention group will receive mandala art therapy in addition to standard preoperative care before cesarean section. The intervention will consist of a single structured mandala coloring session lasting approximately 30-45 minutes and will be administered prior to surgery. The intervention is intended to reduce preoperative surgical fear and psychological stress. |
| Control Group | No intervention | –Pregnant women in this group will receive routine preoperative care without mandala art therapy. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The study sample will consist of high-risk nulliparous women scheduled for elective cesarean section on the same day. Participants will be included if they are 18 years of age or older, diagnosed with high-risk pregnancy conditions (e.g., preeclampsia, gestational diabetes, placenta previa, oligohydramnios, etc.), at term pregnancy (37-42 weeks gestation), with a singleton pregnancy, and able to understand and complete the data collection forms.
Key exclusion criteria (1 listed)
- Women with a diagnosed psychiatric disorder, any condition that impairs communication (such as hearing, visual, or language impairments), those receiving systemic corticosteroid therapy, those with endocrine disorders that may affect cortisol levels, and those with active oral lesions such as aphthous ulcers or other oral mucosal lesions will be excluded from the study.
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 Art TherapyParticipants allocated to the intervention group will receive mandala art therapy in addition to standard preoperative care before cesarean section. The intervention will consist of a single structured mandala coloring session lasting approximately 30-45 minutes and will be administered prior to surgery. The intervention is intended to reduce preoperative surgical fear and psychological stress. | Behavioural | Mandala Art Therapy Group |
Primary outcome
Surgical Fear
Time frame: Baseline (before intervention) and immediately prior to cesarean section
Surgical fear will be measured using a validated surgical fear scale in high-risk nulliparous women undergoing cesarean section.
1 secondary outcome
Salivary Cortisol Level
Time frame: Baseline and immediately prior to cesarean section
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 13 Jul 2026.
- Results publication: PubMed 40409274Okyay EK, Guney E, Coban M. The Effect of Mandala Art Therapy on Anxiety, Mood, and Plasma Glucose Levels in Pregnant Women with Abnormal OGTT Values: A Randomized Controlled Study. Z Geburtshilfe Neonatol. 2025 Dec;229(6):436-445. doi: 10.1055/a-2586-3747. Epub 2025 May 23.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. research result will be shared
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.
Ercan Yılmaz, Professor study director
Inonu University Turgut Ozal Medical Center
Esra GÜNEY, Associate Professor principal investigator
İnönü University Faculty of Health Sciences
Melike Tan, Midwife study director
İnönü University Faculty of Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Mandala Art Therapy in people with High-risk Nulliparous Pregnancy, Patients Scheduled for Cesarean Section, Surgical Fear, Preoperative Anxiety, and Cortisol Level, run by Inonu 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 1 inclusion and 1 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 13 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 ESRA GÜNEY, Associate Professor (+90 5432064063, esra.guney@inonu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Fear (time frame: Baseline (before intervention) and immediately prior to cesarean section). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07691320, which also lists 1 linked publication.
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 13 Jul 2026.