High-risk Nulliparous Pregnancy, Patients Scheduled for Cesarean Section, Surgical Fear, Preoperative Anxiety, and Cortisol Level
Conditions
Keywords
Cortisol, Surgical Fear, Cesarean
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.
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
BEHAVIORALMandala 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.
Sponsors
Inonu University
The Scientific and Technological Research Council of Turkey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Fear | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Salivary Cortisol Level | Baseline and immediately prior to cesarean section | Salivary cortisol levels will be measured as a physiological indicator of stress in high-risk nulliparous women undergoing cesarean section. |
Contacts
CONTACTESRA GÜNEY, Associate Professor
CONTACTMelike TAN ÇELİK, midwife
STUDY_DIRECTORErcan Yılmaz, Professor
Inonu University Turgut Ozal Medical Center
PRINCIPAL_INVESTIGATOREsra GÜNEY, Associate Professor
İnönü University Faculty of Health Sciences
STUDY_DIRECTORMelike Tan, Midwife
İnönü University Faculty of Health Sciences
Outcome results
None listed