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CTRI Number  CTRI/2024/05/067900 [Registered on: 27/05/2024] Trial Registered Prospectively
Last Modified On: 24/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Single blinded randomised controlled trial ]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing multimedia versus music for preoperative anxiety in surgical patients. 
Scientific Title of Study   Effect of preoperative multimedia based informative video versus music intervention on perioperaive anxiety in patients undergoing suregry under spinal anaesthesia. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Trishrota Das 
Designation  Post Graduate Student 
Affiliation  Maulana Azad Medical College and associated Lok Nayak Hospital 
Address  Room no. 304 3rd Floor BL Taneja Block Department of Anaesthesiology Maulana Azad Medical College Central Delhi 110002 India

Central
DELHI
110002
India 
Phone  8837344200  
Fax    
Email  trishrotad@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kirti Nath Saxena 
Designation  Director Professor 
Affiliation  Maulana Azad Medical College and associated Lok Nayak Hospital 
Address  Room no. 304 3rd Floor BL Taneja Block Department of Anaesthesiology Maulana Azad Medical College Central Delhi 110002 India

Central
DELHI
110002
India 
Phone  23238058  
Fax    
Email  kirtinath@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Trishrota Das 
Designation  Post Graduate Student 
Affiliation  Maulana Azad Medical College And ass 
Address  Room no 304 3rd Floor BL Taneja Block Department of Anaesthesiology Maulana Azad Medical Central Delhi 110002 India

Central
DELHI
110002
India 
Phone  8837344200  
Fax    
Email  trishrotad@gmail.com  
 
Source of Monetary or Material Support  
Maulana Azad Medical College and associated Lok Nayak Hospital,Central Delhi, PIN 110002, India 
 
Primary Sponsor  
Name  Maulana Azad Medical College and associated Lok Nayak  
Address  Maulana Azad Medical College and associated Lok Nayak Hospital, JLN Marg New Delhi ,110002 
Type of Sponsor  Government medical college 
 
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 Kirti Nath Saxena   Maulana Azad Medical College and associated Lok Nayak Hospital New Delhi Pin 110002  Department of Anesthesiology B L Taneja Block Room number 304,Maulana Azad Medical College and associated Lok Nayak Hospital New Delhi Pin 110002, India
Central
DELHI 		 011-23501260

kirtinath@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Maulana Azad Medical College and associated hospitals, New Delhi 110002Institutional Ethics committee   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 
Comparator Agent  Group M (Music)  Participants in this group will be made to listen music of their own preference in the preoperative room for 7 minute. 
Intervention  Group V (video)  Participants of group V will be shown an informative video of 7 minute duration regarding Spinal anaesthesia. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patient of either sex,age 18-60years.
2. Patients belonging to American Society of Anaestheiologists Grade 1 and 2.
3. Patients undergoing elective surgery of duration 2-3 hours. 
 
ExclusionCriteria 
Details  1. Patients who are on anti anxiety or anti depressants or beta blockers.
2. Obstetric patients.
3. Patients suffering with visual or hearing impairment.
4. Patients suffering from intellectual disability or any other psychiatric illness. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
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   10 minute before surgery
30 minute after completion of surgery
6 hours after surgery  
 
Secondary Outcome  
Outcome  TimePoints 
The preoperative and postoperative serum cortisol level and postoperative patient satisfaction score between the two groups.  30 minute after completion of surgery.
6 hours after surgery  
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   04/06/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   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. 
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