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临床试验/NCT06062160
NCT06062160已完成不适用

The Effect of Therapeutic Touch on Pain and Comfort After Cesarean Section

Cukurova University2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年1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
90
试验地点
2
主要终点
Postpartum Comfort Scale

研究概览

简要总结

This study was conducted as randomized controlled study to evaluate the effect of Therapeutic Touch on acute pain and comfort level in women who delivered by cesarean section. Personal information form was used as data collection form, VAS was used to assess pain, and PPCQ was used to assess comfort. When power analysis was performed, the sample size was calculated to be at least 45 participants for each group (45 experiments, 45 controls). Experimental group received deep Therapeutic Touch by investigators two time at 10th and 40nd hours after cesarean section.

详细描述

Cesarean section rate is increasing in the world and in our country, and it might bring other problems with it. Pain, breastfeeding problems and decrease in comfort problems have high chance to happen after cesarean section. The insufficiency of pharmacological methods in reducing the problems experienced after cesarean section and having many side effects increase the using percentage tendency to non-pharmacological methods.

This study was conducted as randomized controlled study to evaluate the effect of Therapeutic Touch on acute pain and comfort level in women who delivered by cesarean section. Personal information form was used as data collection form, VAS was used to assess pain, and PPCQ was used to assess comfort. When power analysis was performed, the sample size was calculated to be at least 45 participants for each group (45 experiments, 45 controls). Experimental group received deep Therapeutic Touch by investigators two time at 10th and 40nd hours after cesarean section.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

Single blind

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • • Those between the ages of 18 and 45
  • Multiparous women
  • At the 8th postoperative hour
  • Women who have not developed any complications during pregnancy, birth and postpartum for themselves or their newborns.
  • Having a single, healthy newborn at term,
  • Does not react negatively to any attempt to touch,
  • Able to speak and communicate in Turkish
  • Agreeing to participate in the study

排除标准

  • Those with any problems diagnosed before or at birth (such as oligohydramnios, preeclampsia, heart disease, diabetes, placenta previa)
  • Those who develop any complications related to mother and baby in the postpartum period (bleeding, hypertension, babies taken to the neonatal intensive care unit, etc.).
  • Those who receive different analgesics other than routine post-operative analgesics (75 mg diclofenac sodium in the first 30 minutes post-op).

结局指标

主要结局

Postpartum Comfort Scale

时间窗: Measurement was taken half an hour after the intervention.

The scale is scored between 34 and 170 points. As the score increases, comfort increases.

Visual Analog Scale

时间窗: Measurement was taken half an hour after the intervention.

The scale is scored between 0-10 points. As the score increases, the pain increases.

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

Meltem Akbaş

Assistant Professor

Cukurova University

研究点 (2)

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