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CTRI Number  CTRI/2024/10/075518 [Registered on: 18/10/2024] Trial Registered Prospectively
Last Modified On: 07/06/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Virtual reality in reducing peri operative anxiety among women undergoing gynecological surgeries 
Scientific Title of Study   Virtual reality versus routine care for decreasing perioperative anxiety in women undergoing gynecological surgeries under general anesthesia: A randomized 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  Dr Shubha Vijay Nayak 
Designation  Junior Resident 
Affiliation  AIIMS Bhubaneswar 
Address  Department of anesthesiology and critical care, All India Institute of Medical Sciences Bhubaneswar, Sijua, Patrapada

Khordha
ORISSA
751019
India 
Phone  9449439981  
Fax    
Email  shubhavnayak@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Swagata Tripathy 
Designation  Professor & Head 
Affiliation  AIIMS Bhubaneswar 
Address  Department of anesthesiology and critical care, All India Institute of Medical Sciences Bhubaneswar, Sijua, Patrapada

Khordha
ORISSA
751019
India 
Phone  8763400534  
Fax    
Email  tripathyswagata@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shubha Vijay Nayak 
Designation  Junior Resident 
Affiliation  AIIMS Bhubaneswar 
Address  Department of anesthesiology and critical care, All India Institute of Medical Sciences Bhubaneswar, Sijua, Patrapada

Khordha
ORISSA
751019
India 
Phone  9449439981  
Fax    
Email  shubhavnayak@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Bhubaneswar, Sijua, Patrapada, Bhubaneswar-751019 
 
Primary Sponsor  
Name  AIIMS Bhubaneswar 
Address  Sijua, Patrapada, Bhubaneswar-751019 
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 Shubha Vijay Nayak  AIIMS Bhubaneswar  Department of anesthesiology and critical care, AIIMS Bhubaneswar, Sijua, Patrapada, Bhubaneswar-751019
Khordha
ORISSA 
9449439981

shubhavnayak@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee All Inda Institute of Medical Sciences Bhubaneswar  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  Routine post operative care  The patients randomized to control group will be induced via routine general anaesthesia protocol same as that of intervention group and after one hour of regaining complete consciousness after extubation will be assessed for post operative anxiety 
Intervention  Virtual reality  The patients will be randomized by simple randomization into 2 groups VRI group or the control group. Patients in VRI group will be educated and exposed to VR headsets. To the VRI group VR headset will be applied 30 min before shifting to OT and continued till a fixed dose of injection Propofol 1.5-2.5mg/kg is given. After extubation once the patient fully regains consciousness and not drowsy and VR will be re applied.. After one hour post extubation and regaining complete consciousness post operative anxiety will be assessed 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  ASA 1 and 2
Aged 18 to 70 years
Undergoing elective gynecological procedures
Under general anaesthesia 
 
ExclusionCriteria 
Details  ASA grades 3,4,5,6
Refusal for participation
History of psychiatric illness
Patient needing ICU backup
Hearing and vision disabilities
Claustrophobic 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess difference in pre and postoperative anxiety in both groups by State Trait anxiety inventory  Pre operative anxiety assessed 45 min before shifting to OT.
Post operative anxiety assessed in PACU just before shifting patient to ward 
 
Secondary Outcome  
Outcome  TimePoints 
To compare mean blood pressure and heart rate at following points-preop, pre and post epidural, after propofol administration at 3 minute time intervals after intubation and in PACU at 5 min, 30 min and 60 min  After Propofol administration at 3 minute time intervals after intubation for first 3 readings and in PACU at 5 min, 30 min and 60 min 
To identify percentage of patients denying VR perioperatively  Perioperative period 
To compare rescue analgesia required in PACU among groups  Post operative period 
To compare patient and anesthetist satisfaction scores among groups  Post operative period 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   29/10/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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  

Introduction

Women often experience higher levels of anxiety compared to men, extending from the preoperative phase through to the postoperative period. This gender disparity in preoperative anxiety can be due to various factors such as biological variances and societal expectations.  Women may face additional stressors related to reproductive health issues or gender-specific surgeries. Therefore, it is important to address perioperative anxiety to optimize patient care and improve surgical outcomes

Numerous distraction methods have been found effective in reducing anxiety, alleviating pain, and improving patient satisfaction. Among these methods, Virtual reality is one. Virtual reality provides a distraction from stress and pain and gives a sense of calmness and relaxation, by immersing patients in digitally created environments. Studies have been conducted to investigate the efficacy of virtual reality in reducing intraoperative anxiety, but research examining its effectiveness in addressing postoperative anxiety is currently lacking.

Study methodology

After recruitment, the eligible patients will be randomized by simple randomization by computer-generated number codes. The allocation to either the Virtual Reality intervention  group or the Control group will be informed over telephone to the researcher by a third person not directly involved in the study. The VRI group will be educated and exposed to VR headsets. They’ll have the option to select videos from categories like forests, underwater scenes, the solar system, and religious themes. They will be explained about touch indications for posturing, attaching monitors, cleaning and draping, and giving injections during preoperative PAC and an education pamphlet will be given.

The night before surgery, patients of both the groups will be advised Tablet Alprazolam 0.25mg as per institute protocol. On the day of surgery, preoperative anxiety will be assessed by State-Trait Anxiety Questionnaire 45 minutes before shifting to the operation theatre in both groups by a blinded third person.

To the VRI group, a VR headset will be applied 30 minutes before shifting to OT and continued till a fixed dose of Injection Propofol 1.5 – 2.5mg per kg iv is given. If epidural anesthesia is administered, it will be accompanied by virtual reality intervention. After extubation, once the patient fully regains consciousness and is not drowsy, consent will be taken to  reapply the virtual reality headset. If they agree, it will be started. If not, they will be asked again in the Post-Anesthesia care unit. If they agree, it will continue for one hour. The used VR is PROCUS One X VR Headset 42mm lenses.

The Control group will undergo routine perioperative management.

Both group patients will be induced with general anesthesia following the standard method which includes preoxygenation, pre-induction with fentanyl 2-3mcg per kg, induction with propofol 1.5-2 mg per kg, neuromuscular blocking agent vecuronium 0.1mg per kg, maintenance by isoflurane MAC 0.9 to 1.0. The Patient will be extubated after administration of neostigmine and glycopyrrolate to reverse the effect of neuromuscular blockade. Antiemetic prophylaxis Dexamethasone 0.1mg per kg will be given during pre-induction and ondansetron 0.1mg per kg will be given at the end of surgery. If the patient complains of nausea and vomiting in PACU Metoclopramide 10mg will be given. Injection Tramadol 1 mg per kg in 100ml NS will be given if VAS more than 4.

After one hour of complete consciousness restoration in the Post-Anesthesia Care Unit, both study groups will undergo assessment for postoperative anxiety using the STAI questionnaire and evaluation of patient satisfaction by a third-party blinded assessor. Additionally, anesthetist satisfaction will be assessed using a five-point Likert scale.

Mean Blood pressure and heart rate will be measured at the following points: Preop, pre and post epidural, after propofol administration, after intubation first three readings at 3-minute intervals, and in PACU at 5 minutes, 30 minutes, and 60 minutes.

In PACU injection Tramadol 1mg per kg in 100ml NS will be given if VAS more than 4.

Anesthetists will receive training on how to properly apply and adjust the VR headset for the patient. 


 
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