跳至主要内容
临床试验/NCT06626958
NCT06626958招募中不适用

The Effect of the Stress Ball Used in the Active Phase of Labor on Labor Pain and Birth Comfort

Ataturk University2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2024年11月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
140
试验地点
2
主要终点
Lapor Pain

研究概览

简要总结

The aim of the clinical trial is to examine the effect of a stress ball applied to pregnant women during the active phase of labor on labor pain and labor comfort. The effect of the stress ball used in the experimental group on labor pain and labor comfort will be evaluated. The stress ball applied to pregnant women during the active phase of labor minimizes labor pain and increases labor comfort H 0: The stress ball used during the active phase of labor has no effect on labor pain and labor comfort.

H 1: The stress ball used during the active phase of labor increases labor pain and labor comfort.

The researchers will monitor the pregnant women from the time the cervical dilation is 3-4 cm (from the active phase of labor) until the cervical dilation is 8-9 cm and the experimental group will be asked to use the stress ball. Routine application will be made to the control group. The pain during labor of the experimental and control groups will be evaluated with the VAS scale. After the birth, the labor comfort scale will be applied to measure labor comfort.

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 (Outcomes Assessor)

盲法说明

The researcher performing the statistical analysis will not know which data is the experimental group and which is the control group.

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

  • Vaginal birth
  • Pregnant women between the ages of 18-40

排除标准

  • Risky pregnancy

结局指标

主要结局

Lapor Pain

时间窗: First measurement: Within the first hour of labor Second Measurement: Within 10-12 hours of labor

The VAS scale will be used to evaluate the level of labor pain in the intervention and control groups. VAS is scored from 1 to 10. As the score obtained from the scale increases, it shows that the labor pain also increases. After the pre-test and the intervention, it is expected that the pain will change in the interventionl group and the VAS score will change.Measurement will begin when cervical dilation is 3-4 cm, and the final test will be performed and completed when cervical dilation is approximately 7-8 cm. This will take approximately 10-12 hours.

Labor Comfort

时间窗: First measurement: Within the first hour of labor Second Measurement: Within 10-12 hours of labor

The minimum score on the scale is 9 and the maximum score is 45. It indicates that as the score value of the scale increases, comfort increases, and as the score value decreases, comfort decreases.The minimum score on the scale is 9 and the maximum score is 45. As the score of the scale increases, it indicates that comfort increases, and as the score decreases, comfort decreases. The birth comfort scale will be applied when the cervical dilatation reaches 7-8 cm. It is expected that the birth comfort will be higher in the intervention group than in the experimental group. The scale will be applied within the first hour when the cervical dilatation reaches 7-8 cm.

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

Sibel ÖZTÜRK

Associate Professor

Ataturk University

研究点 (2)

Loading locations...

相似试验