跳至主要内容
临床试验/CTRI/2024/03/063964
CTRI/2024/03/063964招募中4 期

Effect of preoperative educational video on perioperative anxiety in patients undergoing lower segment caesarean section in Indian Setting: A Randomised Controlled Study

All India Institute of Medical Sciences Bhopal1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年3月31日最近更新:

试验速览

阶段
4 期
状态
招募中
入组人数
90
试验地点
1
主要终点
To estimate and compare the effect of the preoperative educational video on perioperative anxiety by using the state anxiety inventory (Spielberger’s STAI) and Amsterdam preoperative anxiety scale.

研究概览

简要总结

The prevalence of preoperative anxiety among obstetric patients who underwent lower segment caesarean section (LSCS) varies from 55% - 63%. This anxiety could lead to decreased postoperative satisfaction, delayed postoperative recovery, decreased quality of life, increased requirement of anaesthetics and analgesics, longer wound healing, longer hospital stay and hence the overall poor surgical outcome .

Pain during the subarachnoid block, being awake during surgery, seeing or hearing during surgery, privacy breach, being paralysed after surgery and failure to wake up after surgery are some reasons why obstetric patients develop preoperative anxiety related to regional anaesthesia.

The preoperative educational video is one of the recently explored non-pharmacological measures to decrease preoperative anxiety, with variable effects in previous studies.

But these studies have been done in developed countries and may not apply to all socioeconomic and cultural settings. Also, there is a literature deficit regarding the effect of educational videos on the quantitative EEG (marker for stress/anxiety) to decrease perioperative anxiety.

So, this study intends to evaluate the effect of cost-effective anaesthetic educational video on perioperative anxiety by incorporating the anxiety questionnaires and quantitative EEG in patients undergoing LSCS in the Indian setting.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • all consenting primigravida patients scheduled for the LSCS under subarachnoid block.

排除标准

  • visual or hearing impairment or psychiatric or anxiety disorder or history of previous surgery.

结局指标

主要结局

To estimate and compare the effect of the preoperative educational video on perioperative anxiety by using the state anxiety inventory (Spielberger’s STAI) and Amsterdam preoperative anxiety scale.

时间窗: The night before surgery, 30 minutes before surgery, and 1 hour after surgery

次要结局

  • To estimate and compare the effect of the preoperative educational video on the perioperative quantitative EEG(The night before surgery, 30 minutes before surgery, and 1 hour after surgery)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Ashutosh Kaushal

All India Institute Of Medical Sciences, Bhopal

研究点 (1)

Loading locations...

相似试验