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临床试验/NCT06380400
NCT06380400已完成不适用

The Effect of Foot Bath on Birth Pain and Birth Comfort in the First Stage of Labour

Selcuk University2 个研究点 分布在 2 个国家目标入组 196 人开始时间: 2024年2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
196
试验地点
2
主要终点
Visuell analog scale score of the pregnant woman

研究概览

简要总结

Although childbirth is seen as a natural, happy, meaningful and universal experience, women are often faced with severe pain, discomfort and a sensory state that can be overwhelming. There are two ways to reduce labour pain: pharmacological (drugs) and non-pharmacological (non-drug methods). Non-pharmacological methods, in particular, attempt to relieve pain by addressing emotional, cognitive, behavioural and socio-cultural dimensions. These methods provide relief and reduce the perception of pain. One of the non-pharmacological methods used to reduce labour pain is footbaths. Footbaths are widely used as a nurse/midwife intervention in many countries. Footbathing is a simple technique used to induce a sense of comfort and relaxation. It involves gently immersing the patient's legs and feet (below the knees) in a basin of warm water. Local heat treatments are generally safe and are considered an effective form of complementary medicine. In its simplest form it means "a tool to be part of supportive care, promoting peace, positive emotions, comfort, satisfaction and enjoyment". The mechanisms responsible for the effects of footbathing are not fully understood, but soaking the feet in warm water and stimulating the sense of touch through massage or washing can reduce sympathetic nerve activity, thereby reducing pain and increasing comfort. In other words, reducing pain during labour means providing support and comfort to the woman. This study was designed to evaluate the effect of a foot bath applied in the first stage of labour on labour pain and comfort in nulliparous women.

详细描述

The purpose of the study will be explained to pregnant women found to meet the inclusion criteria, and written informed consent will be obtained from participants who volunteer for the study. Participants will be randomly divided into two groups (group 1: intervention group, group 2: control group). Pregnant women will be allocated to the intervention and control groups according to the randomisation scheme to be generated from the random.org website. The personal information form will be used for both intervention and control groups.

Intervention group Pregnant women in the intervention group will receive footbaths for 20 minutes during the active phase of the first stage of labour (after 4 cm cervical dilation) and 20 minutes during the transitional phase of the second stage of labour (9 cm cervical dilation). Pregnant women who completed two footbath sessions were assessed for pain using the visual comparison scale. In addition, the data collection process will be completed by applying the birth comfort scale after two stages of labour.

Control group The process of applying the data collection tools to the pregnant women in the control group is the same as for the intervention group. The pregnant women in the control group will be subjected to the routine practices of the hospital without foot bathing.

Warm water foot bath:

The warm water footbath is performed in 4 steps. Before starting the treatment, warm water is poured into the bucket in which the footbath will take place and the water temperature is set at 41-42°C using a thermometer. In the first stage of the application, the room temperature is between 22 and 25°C. In the second stage, the applicants are made to sit in a chair or armchair. In the third stage, they are allowed to dip their feet into the warm water footbath bucket, where the water temperature is kept between 41 and 42°C, up to the level of the ankles. They are asked to remain in this position for 20 minutes. The temperature of the water is checked between applications and hot water is added when the water cools down. At the end of the treatment, the feet are taken out of the water and dried with a towel. The towel should be left on for 5-7 minutes to allow the heat to work for a while.

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Primipar pregnancy
  • 37 and 42 weeks
  • Cervical dilation at least 4 cm
  • Head presentation
  • Over 18 years of age
  • Pregnant women who agreed to participate after being informed about the study

排除标准

  • People with communication difficulties and mental disabilities
  • Any risk condition related to pregnancy (pre-eclampsia, gestational diabetes, anomalies of presentation, anomalies related to the placenta)
  • Development of maternal-fetal complications
  • Use of anticoagulant therapy
  • Pregnant women with a diagnosed psychiatric illness will be excluded from the study.

结局指标

主要结局

Visuell analog scale score of the pregnant woman

时间窗: within the first 24 hours after the time of the birth of the baby

Pain levels of pregnant women will be assessed. On one side of the scale there is a line labelled 'no pain' and on the other side there is a line labelled 'severe pain' and on the side immediately behind this line there is a scale divided into 10 equal intervals. The higher the score, the greater the intensity of the pain.

次要结局

  • Birth comfort scale score of the pregnant woman(within the first 24 hours after the time of the birth of the baby)

研究者

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

Habibe BAY

Assist prof.

Selcuk University

研究点 (2)

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