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CTRI Number  CTRI/2025/11/098168 [Registered on: 27/11/2025] Trial Registered Prospectively
Last Modified On: 26/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to evaluate the effectiveness of virtual reality video of preoperative and operative areas on the preoperative fear in the patients planned for gynecological surgery 
Scientific Title of Study   Efficacy of virtual tour of preoperative and operative areas using digital twin and Virtual reality technology in reducing preoperative fear in patients planned for elective gynaecological surgeries- A Randomised controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arun Kumar Dora 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, Bhopal 
Address  Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, Bhopal

Bhopal
MADHYA PRADESH
462020
India 
Phone  7000472202  
Fax    
Email  arun.obgy@aiimsbhopal.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Arun Kumar Dora 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, Bhopal 
Address  Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, Bhopal

Bhopal
MADHYA PRADESH
462020
India 
Phone  7000472202  
Fax    
Email  arun.obgy@aiimsbhopal.edu.in  
 
Details of Contact Person
Public Query  
Name  Arun Kumar Dora 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, Bhopal 
Address  Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, Bhopal

Bhopal
MADHYA PRADESH
462020
India 
Phone  7000472202  
Fax    
Email  arun.obgy@aiimsbhopal.edu.in  
 
Source of Monetary or Material Support  
Multi disciplinary research unit, All India Institute of Medical Sciences, Bhopal, Madhyapradesh,India,Pin-462020 
 
Primary Sponsor  
Name  Dr Arun Kumar Dora 
Address  Professor, Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, Bhopal, Madhyapradesh, India, Pin-462020 
Type of Sponsor  Other [PI 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 Arun Kumar Dora  All India Institute of Medical Sciences, Bhopal  All India Institute of Medical Sciences, Bhopal, Madhyapradesh, India, Pin 462020
Bhopal
MADHYA PRADESH 		 07000472202

arun.obgy@aiimsbhopal.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee, All India Institute of Medical Sciences, Bhopal, Madhyapradesh, India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N70-N77||Inflammatory diseases of female pelvic organs, (2) ICD-10 Condition: N80-N98||Noninflammatory disorders of female genital tract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard preoperative counselling  The participants of the comparator arm will be provided with only the standard preoperative counselling. The duration of standard preoperative counselling is about 5 minutes. 
Intervention  VR video  The participants of intervention arm will watch VR video of 3D digital twin of pre operative,operative and postoperative area. Duration of intervention is about 5 minutes. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Female 
Details  1 Who has given consent for the study
2 Age more than or equal to 18 years
3 Admitted for elective gynaecological surgeries
 
 
ExclusionCriteria 
Details  1 Patients who have had any previous major surgery
2 Having any psychiatric disorder
3 Emergency or re-exploration surgery
4 Had some complications in previous surgeries
5 On any anxiolytic, sedative, beta blockers or antipsychotic medications
6 Any malignancy, vision impairment in one or both eyes or hearing impairment
7 Problem preventing effective communications
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
incidence and severity of preoperative fear in patients scheduled for elective gynaecological surgeries will be assessed by surgical fear questionnaire and salivary cortisol level.  The preoperative fear will be assessed on the day before surgery

1. At 10 Am to 2 Pm

2. Again at 5 PM after standard preoperative counselling or/and intervention is over 
 
Secondary Outcome  
Outcome  TimePoints 
clinico-demographic factors influencing preoperative anxiety  1 year 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
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   N/A 
Date of First Enrollment (India)   01/01/2026 
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   This trial is being conducted to evaluate the efficacy of a virtual tour of preoperative and operative areas using digital twin and Virtual reality technology in reducing preoperative fear in patients planned for elective gynaecological surgeries. It will be conducted in a tertiary care hospital. The patients aged 18 years and above admitted for elective gynaecological surgery without having the exclusion criteria will be enrolled. The total estimated sample size for the study is 78. The participants will be randomised to either the intervention group or the control group. The control group will receive only standard preoperative counselling, and the intervention group will receive both a virtual tour of preoperative and postoperative areas in addition to the standard preoperative counselling. The effect of the intervention of virtual tour on preoperative fear will be estimated. 

 
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