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CTRI Number  CTRI/2024/09/073438 [Registered on: 05/09/2024] Trial Registered Prospectively
Last Modified On: 07/06/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Process of Care Changes
Behavioral 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparing The Impact Of Preoperative Education: Videos, Animations, And Traditional Talks On Anxiety And Pain In Patients Undergoing Gallbladder Surgery 
Scientific Title of Study   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 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sachin Chaudhary 
Designation  Junior Resident  
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Department Of Surgical Disciplines, All India Institute Of Medical Sciences, New Delhi

New Delhi
DELHI
110029
India 
Phone  9175222583  
Fax    
Email  sachinchaudhary817@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Ankita Singh 
Designation  ASSISTANT PROFESSOR 
Affiliation  All India Institute of Medical Sciences, Delhi 
Address  Room 407, 4th floor, Department of Surgical Disciplines, Surgery Block, AIIMS, Ansari Nagar, New Delhi
Room 407, 4th floor, Department of Surgical Disciplines, Surgery Block, AIIMS, Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India 
Phone  9355875126  
Fax    
Email  ankitasingh05@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ankita Singh 
Designation  ASSISTANT PROFESSOR 
Affiliation  All India Institute of Medical Sciences, Delhi 
Address  Room 407, 4th floor, Department of Surgical Disciplines, Surgery Block, AIIMS, Ansari Nagar, New Delhi
Room 407, 4th floor, Department of Surgical Disciplines, Surgery Block, AIIMS, Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India 
Phone  9355875126  
Fax    
Email  ankitasingh05@gmail.com  
 
Source of Monetary or Material Support  
All India Institue Of Medical Sciences, Ansari Nagar, New Delhi 110029  
 
Primary Sponsor  
Name  Dr Sachin Chaudhary 
Address  Department of Surgical Disciplines, All India Institute of Medical Sciences, New Delhi - 110029 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sachin Chaudhary  All India Institute Of Medical Sciences, New Delhi   Room 407, 4th floor, Department of Surgical Disciplines, Surgery Block,110029
New Delhi
DELHI 		 9175222583

sachinchaudhary817@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, AIIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Animation   A 3 min animation with audio will be shown to the participants in the admitted area on a multimedia electronic device (Tablet) followed by question answer session. Duration- 5mins 
Comparator Agent  Control group   Participants will be educated by the traditional verbal communication in the admitted area by the surgeon member of the operative team. Duration- 1-3mins 
Intervention  video-based multimedia  A 3 minute video with audio will be shown to the participants in the admitted area on a multimedia electronic device (Tablet) followed by question answer session. Duration- 5mins 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Patients of either gender, age more than 18 years
2. Patient scheduled for Laparoscopic cholecystectomy under General Anaesthesia
3. ASA Grade I and II.
4. Patients able to comprehend English or Hindi language 
 
ExclusionCriteria 
Details  1. Patients not willing to give consent for study/
refusal to participate
2. History of major surgery under general or spinal
anesthesia
3. Patient with known psychiatric illness or
substance use disorder except caffeine
4. History of psychotropic drug intake
5. Patient taking drugs affecting hemodynamics
(beta - blockers)
6. Patient with visual/ hearing impairment
7. Patient with history of Endoscopic retrograde
cholangiopancreatography (ERCP) for complication associated with gall stones
8. Conversion to open cholecystectomy
9. Lengthy surgical procedures (more than 3 hours)
10. Extrasurgical procedures during laparoscopic
cholecystectomy
11. Patient who suffer from intra or postoperative
complications of laparoscopic
cholecystectomy.(biliary injury, vascular injury,
gastrointestinal injury, surgical site infection)
12. Need for transfer to intensive care unit  
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess and compare the impact of preoperative health education between video
based multimedia group versus animation group versus traditional verbal
communication group on postoperative pain perception using VAS score in patients
undergoing laparoscopic cholecystectomy. 		 0, 6 and 12 hrs after surgery  
 
Secondary Outcome  
Outcome  TimePoints 
To assess and compare the impact of preoperative health education between video
based multimedia group versus animation group versus traditional verbal
communication group on perioperative anxiety using Amsterdam Preoperative
Anxiety and Information Scale in patients undergoing laparoscopic cholecystectomy 		 preintervention, postintervention and 1 hr before
surgery 
To compare and correlate perioperative parameters in the 3 groups
a. Average heart rate
b. Average respiratory rate
c. Average systolic blood pressure
d. Average diastolic blood pressure
e. Mean arterial pressure 		 preintervention,
postintervention, 1 hr before surgery, preinduction baseline, during surgery and 6 hrs
postoperative period  
To evaluate patient satisfaction levels following preoperative health education in the
3 groups using Likert Scale  		 Postintervention  
To assess and compare difference in postoperative analgesic requirement in the 3
groups 		 Postoperative 
To assess and compare difference in need for rescue analgesia postoperatively in the
3 groups  		 Postoperative 
To investigate the association between preoperative anxiety levels and postoperative
recovery outcome - length of hospital stay due to pain  		 Postoperative  
 
Target Sample Size   Total Sample Size="390"
Sample Size from India="390" 
Final Enrollment numbers achieved (Total)= "390"
Final Enrollment numbers achieved (India)="390" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   01/10/2024 
Date of Study Completion (India) 05/06/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 05/06/2026 
Estimated Duration of Trial   Years="1"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 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.
 
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