The Effect of Continuous Birth Support Provided by Student Midwives on Labor Outcomes, Birth Perception, and Birth Satisfaction: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in labor pain intensity from baseline to active labor.
研究概览
简要总结
This randomized controlled study aimed to evaluate the effect of continuous birth support provided by senior student midwives on labor outcomes, birth perception, and birth satisfaction. Pregnant women admitted for spontaneous vaginal birth were randomly assigned to either a continuous birth support group or a routine care control group. The intervention consisted of continuous non-pharmacological support provided by trained student midwives under supervision throughout labor. Primary outcomes included perceived birth pain and birth satisfaction, while secondary outcomes included birth perception and obstetric interventions.
详细描述
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.
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
- Single (Participant)
盲法说明
Participants were blinded to group allocation; care providers and investigators were not blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Continuous Birth Support by Student Midwives
Participants received continuous non-pharmacological birth support provided by trained senior student midwifery students under supervision throughout labor.
干预措施: Continuous Birth Support (Behavioral)
Routine Intrapartum Care
Participants received routine intrapartum care without continuous one-to-one birth support.
干预措施: Routine Care (Other)
结局指标
主要结局
Change in labor pain intensity from baseline to active labor.
时间窗: Baseline and during active labor, up to 24 hours
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.
Birth satisfaction measured by the Birth Satisfaction Scale-Revised
时间窗: Up to 24 hours postpartum (Day 1)
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.
次要结局
- Obstetric Interventions(During active labor (cervical dilation 4-10 cm, assessed continuously until delivery and at 1 hour postpartum)