跳至主要内容
临床试验/CTRI/2023/03/050373
CTRI/2023/03/050373尚未招募不适用

Effect Of Preoperative Audio-visual Tools On Quality of Recovery After Elective Caesarean Delivery In A Developing Country Setting - A Randomised Controlled Trial

Post Graduate Institute of Medical Education and Research1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2023年3月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
110
试验地点
1
主要终点
Quality of postoperative recovery, as measured using the ObsQoR-10 scoring tool

研究概览

简要总结

Anxiety before elective caesarean delivery is common, and the factors are multifactorial. High preoperative anxiety can have several unfavourable perioperative effects, and is associated with poor patient satisfaction. Preoperative patient preparation using specifically designed audio-visual tools in the local language can help reduce preoperative anxiety. The effect of such interventions on the quality of recovery (QoR) after elective caesarean section has not been studied.

This prospective randomised trial will explore the effect of preoperative audio-visual tools on the postoperative QoR (primary outcome), preoperative anxiety (secondary outcome) and overall patient satisfaction (secondary outcome) in women scheduled to undergo elective caesarean section.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • •Parturients planned for elective caesarean section under either neuraxial or general anaesthesia.

排除标准

  • •Patient refusal
  • •Parturients who have vision, hearing or speech diabilities
  • •Parturients with psychiatric illnesses
  • •Inability to read and understand the Hindi version of the ObsQoR-10 questionnaire.

结局指标

主要结局

Quality of postoperative recovery, as measured using the ObsQoR-10 scoring tool

时间窗: 24 hours postoperative

次要结局

  • Preoperative anxiety, measured using the visual Analogue Scale (VAS)(30 minutes prior to transfer to the operating theatre)
  • Overall patient satisfaction score, measure using a Likert scale(24 hours postoperative)

研究者

发起方
Post Graduate Institute of Medical Education and Research
申办方类型
Research institution and hospital

研究点 (1)

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