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临床试验/CTRI/2024/07/071489
CTRI/2024/07/071489尚未招募不适用

Comparison of virtual reality glasses versus intravenous injection midazolam on anxiety in patients undergoing surgery under regional anaesthesia : A randomised controlled study

Meera chauhan1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年9月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
52
试验地点
1
主要终点
To Assess the effect of virtual reality glasses

研究概览

简要总结

Virtual reality is distraction or diversion tool which has been useful in reducing the anxiety , decreasing pain levels and improving patient’s comfort levels during intraoperative periods . Virtual reality reduces procedural anxiety by reducing patient’s attention into the computer generated world , as the virtual reality “transports” the patient from clinical settings to another “ reality”.

Aim : To Assess the comparision of virtual reality glasses versus intravenous injection midazolam on anxiety in patients undergoing surgery under regional anaesthesia.

•Study Design : Randomized controlled study.

•Study Population : Patients undergoing surgery under regional anaesthesia between 18 – 60 years of age. •Study Duration : 15 months

. •Duration of Data collection : 12 months .

•Sample Size : 52 (26 in each group)

Sampling method : Simple random sampling

•The patients will be allocated to respective groups by computer generated random sequence numbers.

•V GROUP : Patients in this group will receive the virtual reality glasses.

•M GROUP : Patient in this group will receive the midazolam (0.02 mg/kg, maximum:- 2.5 mg) intravenously and is a control group.

Anxiety score will be measured preoperatively, intraop and  after 15 min, after 30 min. after 45 min after 60 min andpostop Analysis will be done using appropriate method.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • 1.Patients age between 18 to 60 years undergoing surgery under regional anaesthesia 2.Patients having ASA (American society of anaesthesiology) physical status I,II and III 3.Surgery duration: maximum 1 hour.

排除标准

  • 1.Patients with known psychiatric disorders
  • Patients with audio visual impairment.

结局指标

主要结局

To Assess the effect of virtual reality glasses

时间窗: PreOp,Intraop,After 15 mins,After 30 mins,After 45 minsAfter 60 mins,Post OP

versus intravenous injection midazolam on

时间窗: PreOp,Intraop,After 15 mins,After 30 mins,After 45 minsAfter 60 mins,Post OP

anxiety levels in patients undergoing surgery

时间窗: PreOp,Intraop,After 15 mins,After 30 mins,After 45 minsAfter 60 mins,Post OP

under regional anaesthesia perioperative period

时间窗: PreOp,Intraop,After 15 mins,After 30 mins,After 45 minsAfter 60 mins,Post OP

using Spielberger State-Trait Anxiety Inventory-6

时间窗: PreOp,Intraop,After 15 mins,After 30 mins,After 45 minsAfter 60 mins,Post OP

(STAI-6) score.

时间窗: PreOp,Intraop,After 15 mins,After 30 mins,After 45 minsAfter 60 mins,Post OP

次要结局

  • To Compare the following parameters in both the(groups:)

研究者

发起方
Meera chauhan
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr. Meeraben Chauhan

Government Medical College Bhavnagar

研究点 (1)

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