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临床试验/NCT07060339
NCT07060339已完成不适用

The Effect of Pain Coping Methods Used in the Active Phase of Labour on Birth Outcomes

Uskudar University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年1月27日最近更新:
适应症
干预措施

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
1
主要终点
Visual Comparison Scale (Vizual Analogue Scale -VAS)

研究概览

简要总结

The aim of this clinical trial is to evaluate the effects of methods such as exercise and hot showers applied during the active phase of labour on labour pain, labour duration, mode of delivery, newborn health, and the labour experience. In addition, the safety of these methods in terms of maternal and infant health will also be observed.

The main questions it aims to answer are:

Do exercise and warm shower applications reduce labour pain?

Do these methods shorten the duration of labour?

Is there a relationship between exercise and warm shower applications and the mode of delivery (vaginal birth/caesarean section)?

Do these practices affect the newborn's APGAR score?

Do women who use these methods have a more positive birth experience?

Participants:

Women who have started labour, are between 38 and 42 weeks pregnant, are expecting a single baby, and are having their first birth.

Participants will be randomly assigned to one of four groups:

Exercise

Warm shower

Exercise + warm shower

Pharmacological intervention (control group)

What is expected of participants:

Participate in exercise, warm shower, breathing exercises, and massage applications (depending on the group they are in) throughout the labour process

Participate in monitoring and evaluations during clinical check-ups

Complete postpartum questionnaires and scales related to the birth experience

This clinical study is being conducted to scientifically evaluate the effectiveness of non-pharmacological methods used during childbirth and to improve the birth experience.

详细描述

In the study, data were collected face-to-face with a single midwife. The data used in the study were the Informed Consent Form; the Informative Information Form developed by the researchers in line with the literature Information Form , the Birth Monitoring Form used during childbirth, the Visual Analogue Scale - VAS, the Postpartum Assessment Form, and the Birth Experience Scale.

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 Days 至 45 Days(Child)
性别
Female
接受健康志愿者
是

入选标准

  • •Criteria for Inclusion in the Study:
  • •In labour,
  • •Nulliparous,
  • •Cervical dilation greater than 3 cm,
  • •Full-term pregnancy (between 38 and 42 weeks of gestation),
  • •Carrying a single live foetus. *Reason for selecting nulliparous women: Multiparous women were excluded to randomise birth memory and avoid influencing case outcomes, as previous birth experiences may influence pain perception and birth experience.

排除标准

  • •for Participants:
  • •Multiparity,
  • •High-risk pregnancies were not included in the study sample.

研究组 & 干预措施

1. Intervention Group 1 - Exercise Programme

Experimental

Participants in this group were provided with midwifery care, breathing exercises, massage and exercise programmes during the active phase of labour. This group was formed to monitor the effects of exercise on the labour process.

干预措施: Exercise Programme (Behavioral)

2. Intervention Group 2 - Hot Shower Programme

Experimental

Participants in this group received midwifery care, breathing exercises, massage, and hot shower applications during the active phase of labour. This arm was designed to evaluate the effects of hot showers on labour pain, duration, and comfort.

干预措施: Hot Shower Programme (Behavioral)

3. Intervention Group 3 - Combined Application (Exercise + Hot Shower)

Experimental

In this group, midwifery care, breathing exercises, massage, exercise, and hot shower applications were applied together during the active phase of labour. This arm was designed to examine the effects of combining multiple non-pharmacological methods.

干预措施: Combined Application (Exercise + Hot Shower) (Behavioral)

4. Intervention Group - Pharmacological Intervention

Experimental

This group was monitored during the birth process with only midwifery care and routine pharmacological interventions. It serves as the standard care group that did not receive non-pharmacological interventions for comparison with other groups.

干预措施: Pharmacological Intervention (Behavioral)

结局指标

主要结局

Visual Comparison Scale (Vizual Analogue Scale -VAS)

时间窗: VAS is used repeatedly during the 4-5 cm, 6-7 cm, 8-9 cm and full dilation stages of labour, before and after massage, exercise and hot shower applications, and during intervention when necessary.

VAS was used before and after each intervention to assess the level of pain during the birth process. Repeated measurements were taken between applications to monitor changes in pain and measure the effectiveness of the interventions.

Birth Experience Scale (BES)

时间窗: By assessing her overall satisfaction with the birth process, it measures how she felt about the birth process and her physical and emotional experiences. It was completed within 24 hours after birth.

It consists of 22 items and has 4 sub-dimensions.

次要结局

未报告次要终点

研究者

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

Tuğba YILMAZ ESENCAN

assistant professor

Uskudar University

研究点 (1)

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