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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 142
- 主要终点
- Surgical Fear
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Control Group
Pregnant women in this group will receive routine preoperative care without mandala art therapy.
Mandala Art Therapy Group
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.
干预措施: Mandala Art Therapy (Behavioral)
结局指标
主要结局
Surgical Fear
时间窗: 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.
次要结局
- Salivary Cortisol Level(Baseline and immediately prior to cesarean section)