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临床试验/NCT05186532
NCT05186532已完成不适用

To What Extent Does Application of Dry Heat is Effective in Promoting Episiotomy Wound Healing and Reducing Pelvic Pain Among Primipara Women?

Alexandria University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年1月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Pelvic pain

研究概览

简要总结

Objective: To compare the effect of dry heat versus moist heat application on episiotomy wound healing and pain among postnatal mothers.

Research hypothesis H0: Postnatal mothers who apply dry heat on their episiotomy wound experience the same wound healing and pain as those who apply moist heat.

H1: Postnatal mothers who apply dry heat on their episiotomy wound experience faster wound healing and less pain than those who apply moist heat.

H2: Postnatal mothers who apply moist heat on their episiotomy wound experience faster wound healing and less pain than those who apply dry heat.

详细描述

A quasi-experimental study was carried out at Abu EL-Matamer Central Hospital and Housh Issa Central Hospital. A sample of 100 postnatal women were randomly assigned into two equal groups. Women in the control group received the moist heat, which entails; sitting in a warm water tub up to the hip level. While, the study group were subjected to infra red-light therapy that supplies radiant heat or infra-red rays to produce heat to the episiotomy wound.

Women who fulfilled the criteria from the postnatal inpatient ward at Abu EL-Matamer Central Hospital and Housh Issa Central Hospital in El-Beheira Governorate. Each woman was randomly assigned to one of the (dry heat or moist heat) groups. The researchers explained the aim of the study to every woman, and then her consent to participate in the study was obtained.

All study subjects were individually interviewed by the researchers on the first two hours after delivery during hospital stay to collect the basic data, episiotomy pain intensity was assessed by, as well as the researchers inspect the episiotomy site for Redness, Edema, Ecchymosis, Discharge and Approximation of the wound edges using REEDA scale within 2 hours after episiotomy repair to evaluate wound healing (Pretest).

After the assessment the researchers provided clear and concise information through illustrative pamphlet for the both groups.

Dry heat group included 50 postnatal women they were encouraged to place an infrared lamp at distance of 45 cm from the perineum and the heat produced with 230 volts for ten minutes. But the mother is checked after the first five minutes to make sure that she was not being burned. The researchers were demonstrated for each woman how to use infrared lamp, and it was followed by re demonstrations and discussions. After 12 hours of episiotomy this procedure was carried out in the morning and evening for ten consecutive days. The researcher gives the infrared lamp device for each woman then restore it after completion of the study.

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)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Primipara
  • First 2 hours after delivery
  • Have a normal vaginal delivery
  • Have episiotomy
  • complaining of perineal discomfort (pain)
  • Having a telephone for contact

排除标准

  • The women who were
  • use any pain-relieving drug
  • labor complications
  • postpartum complications
  • Illiterate

结局指标

主要结局

Pelvic pain

时间窗: After 10 days

The researchers measured the pelvic pain intensity using Visual analogue scale: This scale was adopted and translated to an Arabic version to be used in the current study. It was developed by Melzack and Katz (1994). It is a self-reported device consisting of a horizontal line used for subjective estimation of patient's pain. It comprises 10-point numerical scale, corresponding to the degree of pain with zero representing no pain and 10 representing the worst degree of pain. Scores 1, 2, 3 indicate mild pain, while 4, 5, 6 scores indicate moderate pain and 7, 8, 9 scores indicate severe pain; finally, 10 indicate the worst unbearable pain

Episiotomy wound healing

时间窗: After 10 days

The researchers assessed episiotomy wound healing using The standardized Redness, Oedema, Ecchymosis, Discharge, Approximation (REEDA) scale ; The REEDA scale is an observational check list used for assessing perineal wound healing that was primarily developed by Davidson (1974). It can be used to assess all types of postpartum perineal trauma. It has five components namely Redness, Edema, Ecchymosis, Discharge and Approximation of the wound edges. Each component takes a score ranged from 0 to 3 . Total REEDA score ranges between 0 and 15. Higher score indicates poor wound healing while lower score indicates good wound healing. The total score of REEDA scale was categorized as follows; Completely healed from 0 to 2 , Moderately healed from 3 to 5 , Mildly healed from 6 to 8, and Not healed from 9 to 15

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zohour Ibrahim Mahmoud Rashwan

lecturer

Alexandria University

研究点 (2)

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