Effects of Digital Vaginal Examination During Labor on Pain and Anxiety : a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Anxiety levels
研究概览
简要总结
Digital vaginal examination is the most common method for assessing progress of labor and delivery. Considering it is the most common intervention women receive during course of labor, evidence for psychological effects of digital vaginal examination on women is surprisingly sparse. Reducing the number of vaginal examination during labor has been proposed by many authors as benefit of more vaginal examination is unclear. However this is unlikely to happen until more research on the topic demonstrates clear detrimental effects of vaginal examination.
Our study is aimed at investigating association of vaginal examination with psychological distress of women during labor. Anxiety during labor is associated with longer labor duration, increased perception of pain, problems with newborn attachment, and increased rates of postpartum depression and post-traumatic stress disorder. In this study, women were assigned to either digital vaginal examination or transperineal ultrasound assessment groups were compared to each other in a randomised controlled setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Multiparous women
- •Spontaneous active labor
- •Cephalic presentation
排除标准
- •Women with known psychiatric disorders
- •Labor induction
- •Advanced labor during admission (Dilatation greater than 7cm)
- •Presence of a prenatally diagnosed anomaly in fetus
- •Admission to neonatal intensive care unit after delivery
- •Delayed hospital discharge due to excessive weight loss of neonate
结局指标
主要结局
Anxiety levels
时间窗: Between 12 to 48 hours
Anxiety levels of the patients will be assessed with the State-Trait Anxiety Inventory (STAI) questionnaire during admission, at the beginning of active phase of stage one and four hours after delivery.
Labor pain
时间窗: Between 12 to 48 hours
Perceived pain level of the patients will be assessed with Visual Analog Scale (VAS) questionnaire during admission, at the beginning of active phase of stage one and four hours after delivery.
次要结局
未报告次要终点
研究者
Erkan Kalafat
Research Assistant
Ankara University
