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临床试验/CTRI/2020/11/028906
CTRI/2020/11/028906尚未招募不适用

Assessment of Preoperative Stress,Anxiety and Predictive Factors in Patients Undergoing Elective Surgery Under Regional and General Anaesthesia

Department of Anaesthesia1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年11月17日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
试验地点
1
主要终点
Assessment of Stress ,Anxiety and factors in Patients undergoing Elective Surgery Under Regional and General Anaesthesia

研究概览

简要总结

All The patients anxiety level will be assessed utilizing questionnaire having the Amsterdam Preoperative Anxiety and Information Scale (APAIS) translated in Hindi /English language and visual analogue scale for anxiety (VAS-A). The VAS-A is based on a 100 mm scale with zero anxiety on the far left and maximum preoperative anxiety on the far right. A higher score indicates higher anxiety. The APAIS consists of six items on two scales: APAIS-Anxiety (four items) and APAIS-Need-for-Information (two items). APAIS-Anxiety has two subscales: Anxiety about Anaesthesia (two items) and Anxiety about Surgery (two items). Patients having  APAIS < 11will be considered to  be non anxious , while patients with anxiety (≥ 11 on the APAIS-Anxiety scale ) are considered anxious.9 The anaesthesia/surgery related anxiety will be further evaluated by   the Anaesthesia- and Surgery-dependent Preoperative Anxiety (ASPA) questionnaire   using a five-point Likert scale (1, never; 2, low; 3, moderate; 4, strong; 5, extreme).10 The patients will be assessed  twice, one day prior to surgery while doing scheduled pre anaesthetic visit and half an hour prior to induction. The patients will be educated about the anaesthesia technique during pre anaesthetic visit and will be premedicated with tablet alprazolam 0.25mg at night prior and 6am in the morning of surgery. The patients will be provided anaesthesia as per the standard of care protocol of institution at the discretion of the attending anaesthesiologist.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • •Patients belonging to ASA grade 1 to 3 scheduled for elective surgery under regional or general anaesthesia.

排除标准

  • •Emergency operation Reduced mental status of patient History of psychiatric disdorder Chronic sedative medication Revision of previous operation Patients undergoing long lasting treatment Failure to give written and informed consent.

结局指标

主要结局

Assessment of Stress ,Anxiety and factors in Patients undergoing Elective Surgery Under Regional and General Anaesthesia

时间窗: One Day Before Surgery and Half an Hour prior to Induction

次要结局

  • Assessment of Stress ,Anxiety and Factors in Patients undergoing Elective Surgery under Regional and General Anaesthesia(One day prior to surgery and half an hour prior to induction)

研究者

申办方类型
Government medical college

研究点 (1)

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