Continuous Birth Support by Student Midwives and Labor Pain and Birth Satisfaction (MİDWİFERY)
The Effect of Continuous Birth Support Provided by Student Midwives on Labor Outcomes, Birth Perception, and Birth Satisfaction: A Randomized Controlled Trial
研究概览
详细说明
This randomized controlled trial is designed to evaluate the effect of continuous birth support provided by student midwives on labor pain intensity and birth satisfaction among women giving birth vaginally. The study will be conducted in a maternity hospital setting.
Eligible pregnant women who are admitted to the labor ward and meet the inclusion criteria will be informed about the study and asked to provide written informed consent before participation. After enrollment, participants will be randomly assigned to either an experimental group receiving continuous birth support or a control group receiving routine intrapartum care.
Participants in the experimental group will receive continuous birth support provided by trained student midwives in addition to routine intrapartum care. The intervention will consist of structured breathing exercises guided by student midwives, including slow-paced breathing, patterned breathing during contractions, and relaxation-focused breathing between contractions. The support will begin at admission to the labor ward and continue throughout labor until birth, following a standardized intervention protocol.
Participants in the control group will receive routine intrapartum care according to the standard clinical protocols of the maternity hospital, including regular maternal and fetal monitoring and clinical care by midwives and obstetric staff. No structured breathing exercise program will be provided.
The primary outcome of the study is labor pain intensity, assessed using the Visual Analog Scale (VAS). Pain will be measured at two time points: at admission to the labor ward (baseline) and at cervical dilatation of 6-7 cm.
The secondary outcome is birth satisfaction, assessed within 24 hours postpartum using the Birth Satisfaction Scale-Revised (BSS-R). he study aims to determine whether continuous birth support provided by student midwives is associated with reduced labor pain intensity and increased birth satisfaction compared to routine intrapartum care.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Döşemealti
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Antalya、Döşemealti、土耳其（türkiye）、07190
- Antalya
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Pregnant women aged 18 years or older
- Singleton pregnancy
- Gestational age ≥ 37 completed weeks
- Low-risk pregnancy
- Planned vaginal birth
- Admitted to the labor ward in the latent or early active phase of labor
- No pharmacological analgesia before the first pain assessment
- Ability to communicate and provide written informed consent
Exclusion Criteria:
- High-risk pregnancy requiring continuous medical or obstetric intervention
- Planned cesarean section
- Multiple pregnancy
- Known fetal anomaly
- Use of pharmacological analgesia (e.g., epidural anesthesia, systemic opioids) before baseline pain assessment
- Obstetric complications requiring emergency intervention at admission (e.g., fetal distress, placental abruption, cord prolapse)
- Inability to cooperate with breathing exercises
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：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Continuous Birth Support by Student Midwives
Participants received continuous non-pharmacological birth support provided by trained senior student midwifery students under supervision throughout labor.
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Continuous emotional, physical, informational, and advocacy support provided by senior student midwifery students under supervision during labor, including positioning, breathing techniques, massage, relaxation techniques, and psychological support.
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其他：Routine Intrapartum Care
Participants received routine intrapartum care without continuous one-to-one birth support.
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Standard intrapartum care practices routinely provided in the study setting.
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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 |
|---|---|---|
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Change in labor pain intensity from baseline to active labor.
大体时间：Baseline and during active labor, up to 24 hours
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Labor pain intensity will be assessed using the Visual Analog Scale, a 10-centimeter horizontal line anchored with "no pain" and "worst pain imaginable."
Scores range from 0 to 10. Higher scores indicate greater pain intensity.
The outcome will be the change in participant-reported VAS score from baseline to active labor.
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Baseline and during active labor, up to 24 hours
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Birth satisfaction measured by the Birth Satisfaction Scale-Revised
大体时间：Up to 24 hours postpartum (Day 1)
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Birth satisfaction will be assessed using the Birth Satisfaction Scale-Revised, a validated self-report questionnaire measuring women's satisfaction with the childbirth experience.
The total score ranges from 0 to 40.
Higher scores indicate greater birth satisfaction.
The total scale score will be used as the outcome measure.
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Up to 24 hours postpartum (Day 1)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Obstetric Interventions
大体时间：During active labor (cervical dilation 4-10 cm, assessed continuously until delivery and at 1 hour postpartum
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Frequency of obstetric interventions during labor, including episiotomy, amniotomy, and labor augmentation.
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During active labor (cervical dilation 4-10 cm, assessed continuously until delivery and at 1 hour postpartum
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合作者和调查者
调查人员
- 首席研究员：Seda Serhatlioglu, Doctorate、Antalya Bilim University
出版物和有用的链接
一般刊物
- Bohren MA, Hofmeyr GJ, Sakala C, Fukuzawa RK, Cuthbert A. Continuous support for women during childbirth. Cochrane Database of Systematic Reviews. 2017;7:CD003766. doi:10.1002/14651858.CD003766.pub6
- Hodnett ED, Gates S, Hofmeyr GJ, Sakala C. Continuous support for women during childbirth. Cochrane Database of Systematic Reviews. 2013;7:CD003766. doi:10.1002/14651858.CD003766.pub5
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
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
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2025-SS
- 1919B012325051 (其他赠款/资助编号：TUBITAK 2209-A Undergraduate Research Support Program)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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