| CTRI Number |
CTRI/2026/01/102333 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
25/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Using virtual reality to reduce anxiety and maintain stable vital signs in mothers undergoing Caesarean delivery under spinal anesthesia. |
|
Scientific Title of Study
|
The effect of virtual reality on anxiety and hemodynamic parameters during Caesarean section under spinal anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Patel Abhishek |
| Designation |
Postgraduate student |
| Affiliation |
Mahatma Gandhi Medical College And Hospital |
| Address |
OT complex Department of Anaesthesiology Mahatma Gandhi Medical College And Hospital Sitapura Jaipur Rajasthan
Jaipur
RAJASTHAN
302022
India |
| Phone |
9624596947 |
| Fax |
|
| Email |
patelabhishek2510@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyamvada Gupta |
| Designation |
Professor of Anaesthesiology |
| Affiliation |
Mahatma Gandhi Medical College And Hospital |
| Address |
OT complex Department of Anaesthesiology Mahatma Gandhi Medical College And Hospital Sitapura Jaipur Rajasthan
Jaipur
RAJASTHAN
302022
India |
| Phone |
9413418336 |
| Fax |
|
| Email |
drpriyamvada@hotmail.co.uk |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyamvada Gupta |
| Designation |
Professor of Anaesthesiology |
| Affiliation |
Mahatma Gandhi Medical College And Hospital |
| Address |
OT complex Department of Anaesthesiology Mahatma Gandhi Medical College And Hospital Sitapura Jaipur Rajasthan
Jaipur
RAJASTHAN
302022
India |
| Phone |
9413418336 |
| Fax |
|
| Email |
drpriyamvada@hotmail.co.uk |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Medical College and Hospital Sitapura Jaipur Rajasthan 302022 |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical College and Hospital |
| Address |
Department of Anaesthesiology Mahatma Gandhi Medical College and Hospital Sitapura Jaipur Rajasthan 302022 |
| Type of Sponsor |
Private 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 Patel Abhishek |
OT COMPLEX DEPARTMENT OF ANAESTHESIOLOGY |
OT COMPLEX DEPARTMENT OF ANAESTHESIOLOGY MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL SITAPURA JAIPUR RAJASTHAN
Jaipur
RAJASTHAN |
9624596947
patelabhishek2510@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee MGMC Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O94-O9A||Other obstetric conditions, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard Care |
Participants will receive standard perioperative care without virtual reality intervention during caesarean section under spinal anaesthesia. |
| Intervention |
Virtual Reality Exposure |
Participants in the intervention group will receive virtual reality exposure during cesarean section under spinal anaesthesia. A virtual reality headset with headphones will be used to display calming nature scenes or relaxing videos with soothing audio throughout the intraoperative period. The intervention aims to reduce perioperative anxiety and improve hemodynamic stability by distraction and relaxation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.ASA I and II parturients undergoing lower segment
2.cesarean section (LSCS) under spinal anaesthesia.
3.Age 18–40 years.
|
|
| ExclusionCriteria |
| Details |
1.Claustrophobia
2.History of anxiety disorder
3.Severe visual impairment
4.Severe auditory impairment
5.History of motion sickness
6.History of Epilepsy
7.Facial injuries
8.Uncorrected vision problems
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Difference in perioperative anxiety scores between Virtual Reality(VR) and control groups.
|
Difference in perioperative anxiety scores between Virtual Reality(VR) and control groups.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Comparison of intraoperative hemodynamic stability between groups.
Patient satisfaction with the intraoperative experience.
|
|
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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)
|
15/02/2026 |
| 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 Yet Recruiting |
| 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 is a prospective randomized controlled study conducted in the Department of Anaesthesiology at Mahatma Gandhi Medical College and Hospital Jaipur. The study aims to evaluate the effect of virtual reality on perioperative anxiety and intraoperative hemodynamic parameters in patients undergoing cesarean section under spinal anaesthesia. A total of 108 ASA grade I and II parturients aged between 18 and 40 years scheduled for lower segment cesarean section will be enrolled. Participants will be randomly allocated into two groups using computer generated randomization. The virtual reality group will receive immersive virtual reality exposure using a headset with calming visual and audio content during surgery. The control group will receive standard routine perioperative care without virtual reality. Perioperative anxiety will be assessed using the State Trait Anxiety Inventory Six scale before and after surgery. Intraoperative hemodynamic parameters including heart rate blood pressure respiratory rate and oxygen saturation will be recorded at predefined intervals. Patient satisfaction will be assessed postoperatively using a Likert scale. The study aims to evaluate the effectiveness and safety of virtual reality as a non pharmacological method to reduce anxiety and improve patient comfort during cesarean section under spinal anaesthesia. |