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临床试验/NCT06297031
NCT06297031已完成不适用

The Effect of Heat Application to the Sacral Region During The First Stage of Labor On the Pain Level and the Obstetric Outcomes

Istanbul Demiroglu Bilim University2 个研究点 分布在 2 个国家目标入组 134 人开始时间: 2020年4月1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
134
试验地点
2
主要终点
Change From Baseline labor Pain at three times

研究概览

简要总结

The aim of this study was to determine the effect of hot application applied to the sacral region during first stage of labor on women's pain level and labor process.

详细描述

It is stated that the pain experienced during labor, which is a physiological process, creates stress and anxiety in women and increases the risk of maternal and neonatal complications. Therefore, keeping labor pain under control is important from an obstetrical perspective. Pain experienced during labor is caused by dilatation of the cervix and uterine contractions, and occurs in different regions at each stage of labor. Due to the descent of the fetal head into the pelvis and the pressure it puts on the lumbosacral plexus, the mother feels pain in her back, waist, legs and hips, especially in the first stage of labor. Although pharmacological and non-pharmacological methods are used in the management of labor pain, they have disadvantages such as experiencing drug-related side effects due to pharmacological methods, causing undesirable effects in the woman and the fetus, the woman not being able to actively participate in the labor and not being able to remember what happened during labor.

研究设计

研究类型
Interventional
分配方式
Non 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

  • Women were over 18 years of age
  • Primipara
  • Volunteered to participate in the study
  • Were in the latent phase of labor (cervical dilatation 1-2 cm)
  • Had a single fetus in vertex presentation
  • Had no history of pregnancy complications
  • Had not undergone any intervention in the sacral region were included in the study

排除标准

  • Applied pharmacological pain control methods in the first stage of labor
  • Had a cesarean section decision at any stage

研究组 & 干预措施

heat application

Experimental

women in the intervention group were treated with hot water application to the sacral region during the first stage of labor. When the cervical dilatation was 3-4 cm, 5-6 cm and 7-8 cm, heat application was applied a total of 3 times.

干预措施: heat application (Other)

no heat application

No Intervention

No treatment was performed on women in the control group during the study. In the clinic, women's cervical dilatation is routinely checked by the midwife every 2-3 hours, and the progress of labor is monitored by fetal heart rate and fetal monitoring

结局指标

主要结局

Change From Baseline labor Pain at three times

时间窗: The pain was evaluated three times during labor

It will be assessed three times during the first stage of the labor with Number Rating Scale. Pain intensity measured on a Number Rating Scale with scores ranging from 0 - 10. Pain increases as the score increases. The high point describes bad outcome.

次要结局

  • Change From Baseline Fetal Heart Rate(A total of three measurement results were obtained (after the cervical dilatation was evaluated as 3-4 cm, 5-6 cm and 7-8 cm))
  • Change From Baseline APGAR score after delivery(After delivery in two times at first and fifth minutes through study completion, an average of 1 day)
  • Duration of the first stage of labor(through study completion, an average of 1 day)

研究者

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

Tulay Kavlak

Assistant Professor

Istanbul Demiroglu Bilim University

研究点 (2)

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