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临床试验/NCT07659249
NCT07659249尚未招募不适用

THE EFFECT OF PERİNEAL MİRROR USE DURİNG THE SECOND STAGE OF LABOR ON THE DURATİON OF THE SECOND STAGE, RECOVERY, AND PERCEİVED PAİN, SUPPORT, AND CONTROL LEVELS DURİNG DELİVERY

Sakarya University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年6月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
Duration of the Second Stage of Labor

研究概览

简要总结

Objective: This study was designed to evaluate the effect of perineal mirror use during the second stage of labor on the duration of the second stage, postpartum recovery, and perceived pain, support, and control levels during delivery.

Method: The study was designed as a randomized controlled experimental study to examine the effect of perineal mirror use on delivery outcomes in primiparous women. The study population consisted of primiparous pregnant women admitted to the maternity clinic between June 29, 2026, and October 30, 2026. The sample size was calculated using the G*Power 3.1.9.2 program with an effect size of 0.50, 5% Type I error, and 95% power level; a total of 72 participants were selected, 36 in the intervention group and 36 in the control group. Considering potential losses, the sample size was increased by 10%, and a total of 80 pregnant women were planned to be included in the study. Participants were randomly assigned to the intervention group using a perineal mirror and the control group receiving routine care. The following instruments will be used as data collection tools: Pregnancy Demographic Information Form, REEDA Scale, Visual Analog Scale (VAS), and Perceived Support and Control in Childbirth Scale.

Expected Outcome: It is predicted that the perineal mirror may increase the woman's active participation, motivation, and perceived control by allowing her to see the fetal descent and the progress of labor; consequently, it may reduce the duration of active pushing and the duration of the second stage. It is also thought that it may have positive effects on the birth experience, postpartum recovery, and perceived level of support and control. The research results are expected to provide evidence for non-invasive and low-cost applications that can be used in childbirth care.

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
None

盲法说明

No masking will be used in this study. Participants, care providers, investigators, and outcome assessors will be aware of group assignments because the perineal mirror intervention is visible and cannot be concealed during labor.

入排标准

年龄范围
19 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged 19 and over
  • Women with term pregnancy (38+0 - 41+6)
  • Women with singleton pregnancy
  • Women who have had spontaneous vaginal delivery
  • Primiparous pregnant women
  • Women who voluntarily agree to participate in the study will be included.

排除标准

  • Women with high-risk pregnancies
  • Women with multiple pregnancies

研究组 & 干预措施

Perineal Mirror Group

Experimental

Participants in this group will receive perineal mirror use during the active pushing phase of the second stage of labor in addition to routine intrapartum care. The mirror will be positioned to allow visualization of fetal descent and birth progress.

干预措施: Perineal Mirror (Device)

Routine Care Group

No Intervention

Participants in this group will receive routine intrapartum care during labor without perineal mirror use.

结局指标

主要结局

Duration of the Second Stage of Labor

时间窗: During labor (second stage of labor)

Duration of the second stage of labor, measured in minutes from complete cervical dilatation to birth.

次要结局

未报告次要终点

研究者

发起方
Sakarya University
申办方类型
Other
责任方
Principal Investigator
主要研究者

melek balcikcolak

Assoc. Prof.

Sakarya University

研究点 (1)

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