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

N/ANot Yet RecruitingNCT07691320

Inonu University142 enrolled

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

142

Conditions

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Surgical Fear

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

Time frame: Baseline (before intervention) and immediately prior to cesarean section

Secondary Outcomes

Salivary Cortisol Level

Salivary cortisol levels will be measured as a physiological indicator of stress in high-risk nulliparous women undergoing cesarean section.

Time frame: Baseline and immediately prior to cesarean section