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临床试验/CTRI/2024/09/073438
CTRI/2024/09/073438招募中1/2 期

Comparison Of Effect Of Preoperative Health Education Using Video Based Multimedia Versus Animation Versus Traditional Verbal Communication On Perioperative Anxiety And Postoperative Pain In Patients Undergoing Laparoscopic Cholecystectomy

Dr Sachin Chaudhary1 个研究点 分布在 1 个国家目标入组 390 人开始时间: 2024年10月1日最近更新:

试验速览

阶段
1/2 期
状态
招募中
发起方
入组人数
390
试验地点
1
主要终点
To assess and compare the impact of preoperative health education between video

研究概览

简要总结

Comparison Of Effect Of Preoperative Health Education Using Video Based Multimedia Versus Animation Versus Traditional Verbal Communication On Perioperative Anxiety And Postoperative Pain In Patients Undergoing Laparoscopic Cholecystectomy-[PHEVAC]

To be started as a PG thesis after IEC, AIIMS,Delhi approval.

Expected outcome- Change in practice of preoperative health education.

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 90.00 Year(s)(—)
性别
All

入选标准

  • Patients of either gender, age more than 18 years
  • Patient scheduled for Laparoscopic cholecystectomy under General Anaesthesia
  • ASA Grade I and II.
  • Patients able to comprehend English or Hindi language.

排除标准

  • Patients not willing to give consent for study/ refusal to participate
  • History of major surgery under general or spinal anesthesia
  • Patient with known psychiatric illness or substance use disorder except caffeine
  • History of psychotropic drug intake
  • Patient taking drugs affecting hemodynamics (beta.
  • blockers)
  • Patient with visual/ hearing impairment
  • Patient with history of Endoscopic retrograde cholangiopancreatography (ERCP) for complication associated with gall stones
  • Conversion to open cholecystectomy
  • Lengthy surgical procedures (more than 3 hours)
  • Extrasurgical procedures during laparoscopic cholecystectomy
  • Patient who suffer from intra or postoperative complications of laparoscopic cholecystectomy.(biliary injury, vascular injury, gastrointestinal injury, surgical site infection)
  • Need for transfer to intensive care unit.

结局指标

主要结局

To assess and compare the impact of preoperative health education between video

时间窗: 0, 6 and 12 hrs after surgery

based multimedia group versus animation group versus traditional verbal

时间窗: 0, 6 and 12 hrs after surgery

communication group on postoperative pain perception using VAS score in patients

时间窗: 0, 6 and 12 hrs after surgery

undergoing laparoscopic cholecystectomy.

时间窗: 0, 6 and 12 hrs after surgery

次要结局

  • To assess and compare the impact of preoperative health education between video(based multimedia group versus animation group versus traditional verbal)
  • To compare and correlate perioperative parameters in the 3 groups(a. Average heart rate)
  • To evaluate patient satisfaction levels following preoperative health education in the(3 groups using Likert Scale)
  • To assess and compare difference in postoperative analgesic requirement in the 3(groups)
  • To assess and compare difference in need for rescue analgesia postoperatively in the(3 groups)
  • To investigate the association between preoperative anxiety levels and postoperative(recovery outcome - length of hospital stay due to pain)

研究者

发起方
Dr Sachin Chaudhary
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Sachin Chaudhary

All India Institute of Medical Sciences, New Delhi

研究点 (1)

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