The Effect of Mandala Art Therapy on Surgical Fear and the Stress Hormone (Cortisol) in High-risk Pregnant Women Before Cesarean Section.
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
研究概览
地位
干预/治疗
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：ESRA GÜNEY, Associate Professor
- 电话号码：+90 5432064063
- 邮箱：esra.guney@inonu.edu.tr
研究联系人备份
- 姓名：Melike TAN ÇELİK, midwife
- 电话号码：+90 5452259635
- 邮箱：melike9635@gmail.com
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
|
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.
|
|
无干预：Control Group
Pregnant women in this group will receive routine preoperative care without mandala art therapy.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Surgical Fear
大体时间：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.
|
Baseline (before intervention) and immediately prior to cesarean section
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Salivary Cortisol Level
大体时间：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.
|
Baseline and immediately prior to cesarean section
|
合作者和调查者
调查人员
- 研究主任：Ercan Yılmaz, Professor、İnönü University Turgut Özal Medical Center
- 首席研究员：Esra GÜNEY, Associate Professor、İnönü University Faculty of Health Sciences
- 研究主任：Melike Tan, midwife、İnönü University Faculty of Health Sciences
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.