The Effect of Mandala Art Therapy on Surgical Fear and the Stress Hormone (Cortisol) in High-risk Pregnant Women Before Cesarean Section.
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 Art Therapy.
- Who it may be relevant to
- Registry conditions: High-risk Nulliparous Pregnancy, Patients Scheduled for Cesarean Section, Surgical Fear, Preoperative Anxiety, and Cortisol Level. Basic parameters: 18 years — 40 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 →
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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
Overview
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.
Interventions
- Behavioral Mandala Art Therapy
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.
Primary outcome measures
- Surgical Fear [Time frame: Baseline (before intervention) and immediately prior to cesarean section]
Secondary outcome measures (1)
- Salivary Cortisol Level [Time frame: Baseline and immediately prior to cesarean section]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
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. PMID 40409274
Identifiers
NCT: NCT07691320 · 10069