Effects of the Rebozo Technique Applied During the Active Phase of Labor on Labor Pain Intensity and Labor Duration in Primiparous Women: A Parallel-Group Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Labor Pain Intensity Assessed Using the Visual Analog Scale for Pain
研究概览
简要总结
Study Description
Childbirth is a physiological process often accompanied by severe pain and prolonged labor, which may negatively affect maternal well-being and increase the likelihood of obstetric interventions. Non-pharmacological approaches that support physiological labor are recommended as part of evidence-based intrapartum care. The Rebozo technique is a traditional midwifery intervention involving rhythmic pelvic mobilization using a woven cloth to promote maternal comfort, facilitate fetal descent and rotation, and improve labor progression.
This single-center, parallel-group randomized controlled trial aims to evaluate the effectiveness of the Rebozo technique on labor pain intensity and labor duration among primiparous women during the active phase of labor. Eligible participants will be randomly assigned in a 1:1 ratio to either the intervention group, receiving the Rebozo technique in addition to routine intrapartum care, or the control group, receiving routine intrapartum care alone.
The primary outcomes are labor pain intensity, assessed using the Visual Analog Scale (VAS), and labor duration, measured from the active phase of labor (6 cm cervical dilatation) until birth. The findings are expected to provide evidence regarding the effectiveness, feasibility, and clinical applicability of the Rebozo technique as a safe, low-cost, non-pharmacological intervention to support physiological childbirth and improve maternal intrapartum outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Due to the nature of the intervention, blinding of participants and care providers was not feasible. Outcome measures were collected using standardized procedures.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Primiparous women
- •Aged 18-35 years
- •Singleton pregnancy
- •Cephalic fetal presentation
- •Gestational age between 37 and 42 completed weeks
- •Spontaneous onset of labor
- •Cervical dilatation of 6 cm (active phase of labor)
- •No contraindication to vaginal birth
- •Able to communicate in Turkish
- •Provided written informed consent
排除标准
- •Multiple pregnancy
- •Non-cephalic fetal presentation
- •Previous uterine surgery
- •Pregnancy complications requiring emergency obstetric intervention
- •Planned cesarean birth
- •Maternal or fetal conditions requiring immediate delivery
- •Refusal or withdrawal of informed consent
研究组 & 干预措施
Rebozo Group
Participants allocated to this group received the Rebozo technique in addition to routine intrapartum care. The Rebozo technique was applied during the active phase of labor using a standardized protocol consisting of three sessions of approximately five minutes each.
干预措施: Rebozo technique (Procedure)
Rebozo Group
Participants allocated to this group received the Rebozo technique in addition to routine intrapartum care. The Rebozo technique was applied during the active phase of labor using a standardized protocol consisting of three sessions of approximately five minutes each.
干预措施: Routine Intrapartum care (Other)
Control Group
Participants allocated to the control group received routine intrapartum care according to the institutional labor management protocol. No Rebozo intervention was administered.
干预措施: Routine Intrapartum care (Other)
结局指标
主要结局
Labor Pain Intensity Assessed Using the Visual Analog Scale for Pain
时间窗: Immediately before the intervention and immediately after its completion, approximately 15 minutes after the baseline assessment during active labor.
Labor pain intensity was assessed using the 10-cm Visual Analog Scale for Pain, ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity and therefore a worse outcome. Scores were recorded immediately before and immediately after completion of the Rebozo intervention. The control group was assessed at corresponding time points.
次要结局
- Duration of the Active Phase of Labor(From the first documentation of 6 cm cervical dilatation until birth, assessed up to 24 hours.)
研究者
Yeliz Yildirim Varişoğlu
Assoc. Prof.
Istanbul University