The Effect of Mandala Art Therapy on Surgical Fear and the Stress Hormone (Cortisol) in High-risk Pregnant Women Before Cesarean Section.

NCT07691320 | Not Yet Recruiting

• 1 other identifier: 10069
• Study Type: interventional
• Target: 142
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

High-risk Nulliparous Pregnancy, Patients Scheduled for Cesarean Section, Surgical Fear, Preoperative Anxiety, and Cortisol Level

Keywords

Cortisol; Surgical Fear; Cesarean

Outcome Measures

Primary Outcomes (1)

• Surgical Fear

  Surgical fear will be measured using a validated surgical fear scale in high-risk nulliparous women undergoing cesarean section.

  Baseline (before intervention) and immediately prior to cesarean section

Secondary Outcomes (1)

• Salivary Cortisol Level

  Baseline and immediately prior to cesarean section

Study Arms (2)

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.

Behavioral: Mandala Art Therapy

Control Group

NO INTERVENTION

Pregnant women in this group will receive routine preoperative care without mandala art therapy.

Interventions

Mandala Art Therapy BEHAVIORAL

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.

Mandala Art Therapy Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inonu University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Related Publications (1)

• 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 RESULT

Related Links

• Related Info

Study Officials

• Ercan Yılmaz, Professor

  Inonu University Turgut Ozal Medical Center

  STUDY DIRECTOR

• Esra GÜNEY, Associate Professor

  İnönü University Faculty of Health Sciences

  PRINCIPAL INVESTIGATOR

• Melike Tan, Midwife

  İnönü University Faculty of Health Sciences

  STUDY DIRECTOR

Central Study Contacts

ESRA GÜNEY, Associate Professor

CONTACT

+90 5432064063; esra.guney@inonu.edu.tr

Melike TAN ÇELİK, midwife

CONTACT

+90 5452259635; melike9635@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: midwife

Model Details: 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.

Study Record Dates

• First Submitted: June 13, 2026
• First Posted: July 8, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share