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临床试验/NCT04177888
NCT04177888已完成不适用

Effect of Hot Pack on Labor Pain, Duration of Labor, and Satisfaction of Primigravidae Women in Saudi Arabia

King Saud University1 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2018年8月1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
91
试验地点
1
主要终点
Partograph

研究概览

简要总结

The study aimed at determining the effect of hot pack on labor pain reduction and the duration of labor in comparison with routine care. Further, the study also aimed at determining the women's satisfaction with the use of hot pack and with routine care

with hypotheses: H1: Primigravid women who received hot pack in the active phase of labor will have a significantly lower mean labor pain score than those who received routine care.

H2: Primigravid women who received hot pack in the active phase of labor will have significantly shorter mean labor duration than those who received routine care.

详细描述

Childbirth pain is the severest type of pain that women experience in their life. Therefore, effective management of labor pain is essential. There are various methods to control childbirth pain: pharmacological and non-pharmacological such as Entonox and heat therapy respectively. In most Saudi Arabian hospitals, Entonox is used as routine care, while non- pharmacological agents are rarely used. Various forms of heat therapy are effective in labor pain reduction and shortening the duration of labor. There is a dearth for studies that compare the effectiveness of the hot pack with routine care that includes use of Entonox.

Objectives

  • To determine the effect of the hot pack on labor pain reduction among primigravid women.
  • To determine the effect of the hot pack on the duration of labor among primigravid women.
  • To determine the satisfaction of primigravid women regarding hot pack and routine care.

Methods The study was conducted in Armed Forces Hospital Southern Region, with randomized sample of 91 primigravidae with normal pregnancy in active phase of first stage of labor, with cervical dilatation of 6 - 8 cm. This randomized controlled trial consisted of two groups: the experimental group (n = 45) who received hot pack. The control group (n = 46) received routine care including Entonox. Labor pain was assessed by Visual Analogue Scale for pain intensity (VAS); duration of labor was measured by the WHO modified partograph, and women's satisfaction was assessed using a satisfaction scale. Following eligibility assessment, participants were selected and allocated to the groups randomly. After obtaining the written informed consent, the initial assessment was done; the experimental group received hot pack, and the control group received routine care until delivery. The baseline pain score was assessed before the intervention and every 30 minutes after the intervention until delivery. The duration of labor was assessed using the WHO Partograph. The women reported satisfaction two hours post-delivery using the satisfaction scale.

Results:

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

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

  • Saudi primigravid women who:
  • Have normal term pregnancy (37 to 42 weeks) and have normal onset of labor.
  • Are in the active phase of the first phase of labor with cervical dilatation of 6 cm and above and admitted to labor and delivery unit at Armed Forces Hospital Southern Region (AFHSR).
  • Agreed to receive routine care including Entonox inhalation or to hot pack as pain management method during labor.

排除标准

  • Saudi primigravid women who:
  • Are with contraindications for hot packs (fever, area injury or inflammation, skin infection, eczema, bleeding, Deep Vein Thrombosis (DVT), edema and poor thermal regulation),
  • Have complicated pregnancy (polyhydramnios, oligohydramnios, decreased fetal movement, Intrauterine Growth Restriction (IUGR), Intrauterine Fetal Death (IUFD), Ante Partum Hemorrhage (APH), history of infertility, gestational hypertension, gestational diabetes, placenta previa, and placental abruption).
  • Have medical conditions such as asthma, pneumonia, chest infection, chronic disease; such as cardiovascular disease, hypertension, and diabetes.

结局指标

主要结局

Partograph

时间窗: 1-8 hours during labor

The partograph is a universal tool to assess the progress of labor, it included graphical information with three main components; fetal condition, the progress of labor, and maternal condition. The researcher used the progress of labor component in the partograph to calculate the duration of labor in minutes.

Visual Analogue Scale for Pain Intensity (VAS) "change" is being assessed

时间窗: 1-8 hours during labor

It is a one item scale that involves a horizontal or vertical line which starts either with 0 to 10 cm. Zero is no pain and 10 is the worst or intolerable pain. the interpretation is zero no pain, 1 - 3 cm mild pain, 4 - 6 cm moderate pain, 7 - 9 cm severe pain, and 10 cm intolerable or worst pain possible. baseline labor pain assessed, then VAS used every 30 minutes to assess labor pain till delivery

Satisfaction Scale

时间窗: Used two hours post delivery for both group to assess women's satisfaction regarding the intervention and routine care

A Likert-type scale with five points. The scale descriptions: (5) very satisfied, (4) satisfied, (3) neither satisfied nor dissatisfied, (2) dissatisfied, and (1) very dissatisfied

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

Halimah Ali Alshahrani

Midwife, Principal Investigator

King Saud University

研究点 (1)

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