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临床试验/NCT06005077
NCT06005077已完成不适用

Evaluation of the Effect of Perineal Massage and Warm Application on Perineal Trauma, Pain and Birth Comfort in Labor

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
2
主要终点
Perineal Trauma and Bleeding Monitorisation/Measurement Form

研究概览

简要总结

The aim of this study is to determine the effect of perineal massage and warm compress application at first and second stage of labor on perineal trauma, pain and delivery comfort.

详细描述

Perineal trauma is the damage caused by rupture, laceration or episiotomy during birth. Birth-related perineal trauma can lead to many short and long-term physical and psychological morbidities that affect the woman's life. Problems such as pain, bleeding and delay in the attachment of mother and newborn appear in the early postpartum period. In the following period problems such as prolapse, incontinence, sexual dysfunction and anxiety may be experienced.

This randomised controlled study was executed at a research hospital between May 2018 - September 2019. The sample of study is made consisted of three intervention groups and a control group of total 120 pregnant women by randomisation method. Perineal massage, perineal warm compress application, perineal massage and warm compress was done to the intervention groups respectively. Nothing was done to the control group. Perineal massage was given for 10 minutes, warm compress application was done 30 minutes three times when cervical dilatation 3-4 cm, 5-7 cm and 8-10 cm respectively. The data was collected by using Socio-Demographic and Obstetric Data Collection Form, First and Second Stage of Labor Stage Data Collection Form, Childbirth Comfort Scale, Newborn Data Collection Form, Perineal Trauma and Bleeding Monitorisation/ Measurement Form, Visual Analogue Scale, Birth Satisfaction Scale and Perineal Massage and Perineal Warm Compress Application Satisfaction Evaluation Form. When evaluating the data; number, percentage, mean, standard deviation, median, ANOVA Test, Tukey Test, Kruskal Wallis Test, Paired Sample T Test, Friedman Test, Ki-Square Test and Fisher's Exact was used.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

The patients and principle investigator knew which group they were assigned to. Only the outcome assessor didn't know which patient was assigned to which group.

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Primiparous
  • 38"week of pregnancy
  • Singleton pregnancy
  • Cervical dilatation 3"cm
  • Cephalic presentation

排除标准

  • Chronic disease
  • Presence of fetal macrosomia
  • Presence of uterin surgery
  • Presence of fetal anomaly

结局指标

主要结局

Perineal Trauma and Bleeding Monitorisation/Measurement Form

时间窗: In the first 1 hour after birth

The Perineal Trauma, Postpartum Bleeding and Episiotomy Length Evaluation Form was used to record data on perineal trauma and amount of bleeding. The form, created by theinvestigators, consists of 13 questions evaluating conditions such as episiotomy, type of perineal trauma, location and degree of trauma, and postpartum bleeding.

Socio-Demographic and Obstetric Data Collection Form

时间窗: Baseline

The Socio-Demographic and Obstetric Data Form was used to determine the socio-demographic and obstetric characteristics of the participants. This form, created by the investigators, includes 15 questions on age, height, weight, education level, and gestational week of the pregnant women, the way pregnancy occured, and the health problems experienced during pregnancy.

First and Second Stage of Labor Stage Data Collection Form

时间窗: During procedure

The First and Second Stage of Labor Data Form and the Newborn Data Form were used to note down the applications performed on the pregnant woman during the first and second stages of labor and on the newborn after delivery. The form created by the investigators following the review of the literature consists of three parts. In the first part, there are questions regarding the applications such as dilatation, wiping, drugs used in the first stage, amniotomy, and bladder catheterization performed when the pregnant woman is admitted into the delivery room. In the second part, there are questions on the application of local anesthesia in the second stage of labor, protection of the perineum, and the type of pushing. The third part consists of questions regarding the height, weight and APGAR measurement of the newborn. This form includes 33 questions in total.

Childbirth Comfort Scale

时间窗: During the procedure

The Childbirth Comfort Scale (CCS) is used to determine the comfort level at birth. This scale is a 5-point Likert type scale and consists of 14 items. Each item is rated between 1-5 (1: Strongly disagree, 2: Mostly disagree, 3: Partially agree, 4: Mostly agree, 5: Completely agree). The scale has a four-factor structure: physical, psychospiritual, social and environmental.

Visual Analogue Scale

时间窗: During procedure

The Visual Analog Scale (VAS) is a one-dimensional measurement tool used to show perceived pain and its severity. One end of the scale indicates "painlessness (0)" and the other end indicates "the most severe pain possible (10)" .

Perineal Massage and Perineal Warm Compress Application Satisfaction Evaluation Form

时间窗: In the first 1 hour after birth

This form was used to record the phases, periods and durations of perineal massage and perineal heat application, as well as to evaluate the satisfaction with the application. A visual scale graded from 0 to 10 was used in the satisfaction evaluation. It was rated as "0" not at all satisfied, "10" very satisfied.In addition, the participants were asked whether the application was beneficial, whether participants would prefer it when they gave birth again, and whether they would recommend it to others. It was created by the researcher and expert approval was obtained.

Birth Satisfaction Scale

时间窗: In the first 1 hour after birth

The Birth Satisfaction Scale (BSS) is used to evaluate birth satisfaction. This scale is a 5-point Likert-type scale and consists of 30 items. The three main themes of the scale are quality of care, personal characteristics of the women, and stress experienced during childbirth. A minimum of 30 and a maximum of 150 points can be obtained from the scale. Higher scores indicate higher levels of satisfaction.

次要结局

未报告次要终点

研究者

发起方
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gamze Acavut

Asst. Prof

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

研究点 (2)

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