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临床试验/NCT04204395
NCT04204395已完成不适用

Efficacy of Peanut Ball Usage on Labor Pain, Support and Control, Anxiety, and Labor Duration

Taipei Medical University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年12月25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
80
试验地点
2
主要终点
Changed perception of Pain

研究概览

简要总结

*Primary: To compare the control group, women in the experimental group will have lower level of labor pain after the intervention of peanut ball usage.

*Secondary: To compare the control group, women in the experimental group will have higher level of support and control after the intervention of peanut ball usage; To compare the control group, women in the experimental group will have lower level of anxiety after intervention of peanut ball usage; To compare the control group, women in the experimental group will have shorter duration of labor after intervention of peanut ball usage.

详细描述

We will ask the participants to join this research on the department of obstetric outpatient department, and give the consent form to sign. Then we will allocate the participant into the experiment group or the control group, furthermore, we will give the sheet which includes the information about peanut ball usage, like the destination, method, position, duration, and quick response code of the video.

When they finish the admission process in the delivery room, we will give the peanut ball to the participants who is in the experimental group, and the participants of the control group will receive the routine care of delivery room.

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

入选标准

  • vaginal birth;
  • pregnant women at ≥3 6 weeks of gestation;
  • greater than 20 years old of age;
  • no major obstetric or medical complications;
  • singleton pregnancy;
  • the partner will be accompanied during the labor;
  • cervical dilation is less than 5 cm;
  • able to listen, speak, read and write in Chinese;
  • complete the informed consent form.

排除标准

  • emergency cesarean section;
  • diagnosed with metal disease or drug abuser;
  • complicated with abnormality during labor.

结局指标

主要结局

Changed perception of Pain

时间窗: The baseline will be assessed when the cervical dilation is during 0 to 3 centimeters. The three post-tests will be assessed when 30 minutes after each intervention, and cervical dilation is during 5 to 7 centimeters, and during 8 to 10 centimeters.

Perception of Pain assessed by Visual analogue scale for pain(VAS-P). Range of the VAS-P score is 0 to 10, higher scores means worse outcome.

次要结局

  • Duration of labor(within 24 hours after delivery)
  • Changed perception of Support and Control in Birth(The baseline will be assessed when the cervical dilation is during 0 to 3 centimeters. The post-test will be assessed within 24 hours after delivery.)
  • Changed trajectory of Heart Rate Variability(The baseline will be assessed when the cervical dilation is during 0 to 3 centimeters. The three post-tests will be assessed when 30 minutes after each intervention, and cervical dilation is during 5 to 7 centimeters, and during 8 to 10 centimeters.)
  • Changed perception of anxiety(The baseline will be assessed when the cervical dilation is during 0 to 3 centimeters. The three post-tests will be assessed when 30 minutes after each intervention, and cervical dilation is during 5 to 7 centimeters, and during 8 to 10 centimeters.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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