跳至主要内容
临床试验/CTRI/2024/05/067900
CTRI/2024/05/067900尚未招募1/2 期

Effect of preoperative multimedia based informative video versus music intervention on perioperaive anxiety in patients undergoing suregry under spinal anaesthesia.

Maulana Azad Medical College and associated Lok Nayak1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2024年6月4日最近更新:

试验速览

阶段
1/2 期
状态
尚未招募
发起方
入组人数
140
试验地点
1
主要终点
Effect of preoperative multimedia based informative video and music intervention on preoperative anxiety using Visual analogue scale -A (VAS-A) in patients undergoing surgery under spinal anaesthesia

研究概览

简要总结

We will be comparing the effect of preoperative multimedia based informative video versus music intervention in patients undergoing elective surgery under spinal anaesthesia in Lok Nayak Hospital, New Delhi. A total of 140 patients with 70 on each group ( group V and group M) will be enrolled in the study. Patients will be explained about the study and written informed consent will be taken. Group V participants will be shown informative video regarding Spina anaesthesia and groupM participants will receive music intervention of their own preference. Anxiety level will be assessed using visual analogue scale - anxiety  (VAS-A) , serum cortisol level ( baseline and 6 hours after completion of surgery ), Post operative satisfaction score using Likert scale.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

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

入选标准

  • Patient of either sex,age 18-60years.
  • Patients belonging to American Society of Anaestheiologists Grade 1 and
  • Patients undergoing elective surgery of duration 2-3 hours.

排除标准

  • Patients who are on anti anxiety or anti depressants or beta blockers.
  • Obstetric patients.
  • Patients suffering with visual or hearing impairment.
  • Patients suffering from intellectual disability or any other psychiatric illness.

结局指标

主要结局

Effect of preoperative multimedia based informative video and music intervention on preoperative anxiety using Visual analogue scale -A (VAS-A) in patients undergoing surgery under spinal anaesthesia

时间窗: 10 minute before surgery | 30 minute after completion of surgery | 6 hours after surgery

次要结局

  • The preoperative and postoperative serum cortisol level and postoperative patient satisfaction score between the two groups.(30 minute after completion of surgery.)

研究者

发起方
Maulana Azad Medical College and associated Lok Nayak
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Trishrota Das

Maulana Azad Medical College and associated Lok Nayak Hospital

研究点 (1)

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