| CTRI Number |
CTRI/2024/07/069784 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
01/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Preventive
Screening |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of virtual operation room tour on anxiety in patients undergoing major surgeries |
|
Scientific Title of Study
|
Comparative evaluation of preoperative virtual operating room tour vs meditation music in allaying preoperative anxiety A prospective openlabel randomized controlled endpoint blinding study. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vishal Patil |
| Designation |
Postgraduate in MD Anaesthesiology |
| Affiliation |
Karnataka Institute of Medical Sciences Hubballi |
| Address |
Room no. 206, Second floor, Department of Anaesthesiology, Karnataka Institute of Medical Sciences,PB road, Vidyanagar, Hubballi-580022
Dharwad
KARNATAKA
580022
India |
| Phone |
9731616442 |
| Fax |
|
| Email |
vp90755@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhuri S Kurdi |
| Designation |
Professor and Head |
| Affiliation |
Karnataka Institute of Medical Sciences Hubballi |
| Address |
Room no. 206, Second floor, Department of Anaesthesiology, Karnataka Institute of Medical Sciences, PB road , Vidyanagar, Hubballi-580022
Dharwad
KARNATAKA
580022
India |
| Phone |
9449590556 |
| Fax |
|
| Email |
drmadhuri_kurdi@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhuri S Kurdi |
| Designation |
Professor and Head |
| Affiliation |
Karnataka Institute of Medical Sciences Hubballi |
| Address |
Room no. 206, Second floor, Department of Anaesthesiology, Karnataka Institute of Medical Sciences, PB road , Vidyanagar, Hubballi-580022
Dharwad
KARNATAKA
580022
India |
| Phone |
9449590556 |
| Fax |
|
| Email |
drmadhuri_kurdi@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Karnataka Institute of Medical Sciences Hubballi , PB Road, Vidyanagar, Hubballi, Dharwad, Karnataka -580022, India |
|
|
Primary Sponsor
|
| Name |
Karnataka Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Karnataka Institute of Medical Sciences, PB road, Vidyanagar, Hubballi -580022 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vishal Patil |
Karnataka Institute of Medical Sciences Hospital |
Room no. 206, Second floor, Department of Anaesthesiology, Karnataka Institute of Medical Sciences, PB road, Vidyanagar, Hubballi -580022, Karnataka
Dharwad
KARNATAKA |
9731616442
vp90755@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Karnataka Institute of Medical Sciences, Hubballi Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Meditation music using an audio device |
Patients in preoperative room are subjected to hear meditation music of similar duration to VR video using an audio device about 10 minutes before surgery. |
| Comparator Agent |
Nil |
No VR device or meditation music intervention is subjected to the patients. |
| Intervention |
Virtual operating room tour (VORT) using VR device headset |
A three dimensional video of operating room shot on 360degree camera will be shown to patients about 10 minutes before surgery in preoperative room using a VR device headset. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to ASA physical status 1 and 2, giving informed, valid and written consent, undergoing elective major surgery under general and regional anaesthesia. |
|
| ExclusionCriteria |
| Details |
Known mental health disorders, claustrophobia, blindness, deafness, severe visual disorders, heart diseases, history of cerebral vascular accident, emergency surgery, neurosurgery, motion sickness, vestibular dysfunction, COPD, substance abuse, GCS score less than 15 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in preoperative anxiety levels more with Virtual operating room tour (VORT), in comparison with meditation music and nil intervention |
-Preoperative
-10 minutes before surgery
-On table in operating room before induction of anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient satisfaction with Virtual Operating Room Tour(VORT) |
During follow-up in the evening on the day of surgery |
|
|
Target Sample Size
|
Total Sample Size="270"
Sample Size from India="270"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
12/07/2024 |
| 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
|
Fear and anxiety are very common in patients prior to surgery with anaesthesia. This preoperative anxiety is considered as normal patient response and occurs in response to surgical stress. It can lead to additional discomfort, increased pain sensation, increased stress symptoms, leading to psychological and physiological changes such as tachycardia, hypertension, risk of bleeding, poor surgical outcomes and patient satisfaction. Pharmacological interventions have been used to manage preoperative anxiety but have their own drawbacks and can lead to prolonged hospital stay. In recent years, Virtual reality(VR) have become increasingly popular alternative approach to manage preoperative anxiety. VR is a computer technology that provides the feeling of being immersed in a simulated three dimensional(3D) world where the user may interact with the virtual environment. It is reported that VR therapy results in significantly reduced anxiety, faster wound healing, and improved neurohabilitation outcomes. Patients will be exposed to the virtual operation room and experience the surgical environment in advance through VR. This allows patient to become familiar with fearful situations reducing preoperative anxiety.
Aim: To evaluate whether Virtual Operating Room Tour(VORT) reduces preoperative anxiety in comparison with meditation music therapy in adult patients undergoing major elective surgeries.
Objectives:
Primary objective: To compare the reduction in anxiety levels between VORT and meditation music therapy; that means to investigate whether a VORT before surgery can be used to reduce preoperative anxiety.
Secondary objective: 1) To assess the effect of VORT on the patient’s preoperative hemodynamic parameters. 2) To assess patient satisfaction with VORT and their wish to experience virtual reality in case for future surgery.
Materials and methods - A prospective, open-label, randomized controlled, end-point blinding study.
Sample size: 90 in each group.
|