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临床试验/CTRI/2017/03/008248
CTRI/2017/03/008248已完成不适用

A randomized comparative study assessing efficacy of pain vs comfort scores

Dayanand Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2016年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
180
试验地点
1
主要终点
Our primary outcome is to assess pain severity as measured by a 0–10-point VNRS for pain compared with an equivalent inverted VNRS for comfort.

研究概览

简要总结

This is a single blinded randomized study to compare standard pain scores with comfort scores after caesarean section and to determine whether the technique of pain assessment affects patient’s perceptions and experience after caesarean section. One hundred eighty eligible women will be randomly allocated into 2 groups (i.e. group P and group C) of 90 women each, and will be interviewed 6- 24 hours after caesarean section. Group P women will be asked to rate their pain and group C women will be asked to rate their comfort level according to previously validated structured questionnaire. The outcomes of our study is to assess pain severity as measured by a 0–10-point VNRS for pain compared with an equivalent inverted VNRS for comfort and also by a VAS for pain compared with VAS for comfort. Additional outcomes include assessment of level of worry caused by surgical trauma, the requirement of additional analgesia and patient’s perception of postoperative wound as injury or healing

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
Female

入选标准

  • All women who underwent caesarean section.

排除标准

  • 1.Age less than 18 years 2.Deaf and dumb patients 3.Patients with intellectual disability 4.History of chronic pain or opiate abuse.

结局指标

主要结局

Our primary outcome is to assess pain severity as measured by a 0–10-point VNRS for pain compared with an equivalent inverted VNRS for comfort.

时间窗: between 10 to 30 hours

次要结局

  • Our secondary outcomes include:(1.pain severity as measured by a VAS for pain compared with VAS for comfort;)

研究者

发起方
Dayanand Medical College and Hospital
申办方类型
Private medical college

研究点 (1)

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