CTRI

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CTRI Number

CTRI/2026/02/102845 [Registered on: 03/02/2026] Trial Registered Prospectively

Last Modified On:

03/02/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Other (Specify) [Virtual Reality based intervention]

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Using Virtual Reality to Reduce Fear and Anxiety Before Open Heart Surgery: A Prospective Study

Scientific Title of Study

A comparative study assessing the impact of virtual reality based pre education on pre operative anxiety in patients scheduled for open heart surgery : A prospective interventional investigation

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 Jyoti Thakur
Designation	Junior Resident
Affiliation	AIIMS Rishikesh
Address	CTVS Deaprtment, AIIMS Rishikesh , Uttarakhand Dehradun UTTARANCHAL 249203 India
Phone	8628846925
Fax
Email	jyotithakur0905@gmail.com

Details of Contact Person
Scientific Query

Name	Dr. Raja Lahiri
Designation	Associate Professor
Affiliation
Address	CTVS Deaprtment, AIIMS Rishikesh , Uttarakhand Dehradun UTTARANCHAL 249203 India
Phone	99356 15903
Fax
Email	rajalahiri.imsbhu@gmail.com

Details of Contact Person
Public Query

Name	Dr Jyoti Thakur
Designation	Junior Resident
Affiliation	AIIMS Rishikesh
Address	CTVS Deaprtment, AIIMS Rishikesh , Uttarakhand Dehradun UTTARANCHAL 249203 India
Phone	8628846925
Fax
Email	jyotithakur0905@gmail.com

Source of Monetary or Material Support

CTVS Department, AIIMS Rishikesh

Primary Sponsor

Name	CTVS Department
Address	Aiims Rishikesh
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 Jyoti Thakur	AIIMS RISHIKESH	Department of CTVS, Shivaji Nagar, Veerbhadra Road, Rishikesh, Dehradun, Uttaranchal Dehradun UTTARANCHAL	8628846925 jyotithakur0905@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
AIIMS Rishikesh, Institutional Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: I00-I99\|\|Diseases of the circulatory system,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Standard preoperative education	Standard education regarding the surgical process, which include verbal explanations from medical personnel 1 day before the surgery which is usually done in our institution during consent taking. The verbal explanations includes the need for surgery, prepping process, insertion of lines, the incision made and the type of surgery that will be done, common and uncommon risks and complications during and after the surgery, time required for surgery, time required for extubation and post op recovery time.
Intervention	Virtual reality based pre educational video	Arm A: Visual Reality based pre-educational video of 15 min. recorded with the help of a mobile device. The VR program offers a guided simulation of the preoperative preparation including prepping, shifting, the layout of the operating room, insertion of lines and immediate post operative scenario after weaning off from anesthesia in a first person perspective. This video offers a virtual tour that simulates the complete perioperative process, recovery area, and concluding with post-anesthesia care and potential complications. The VR-based intervention features a high-quality fusion camera 24mm f 1.78 at a resolution of 1920 x 1080 pixels with 29.98 FPS. This approach aims to give participants an immersive, first-person experience of the perioperative workflow, care practices, and possible complications.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	80.00 Year(s)
Gender	Both
Details	1. Age more than or equal to 18 yrs 2. Patients undergoing elective cardiac surgery through midline sternotomy 3. Patients who can give informed consent

ExclusionCriteria

Details

1. Patients who are taking other treatment for anxiety,
VR inappropriate ( Epilepsy, cognitive impairments, Visual or hearing impairments, Vestibular Disorders)
2. Patients undergoing emergency surgery or with unstable hemodynamics
3. Patients who have undergone prior surgery involving general or spinal anaesthesia
4. Previously diagnosed serious psychiatric conditions that could hinder participation.

Method of Generating Random Sequence

Permuted block randomization, variable

Method of Concealment

Case Record Numbers

Blinding/Masking

Participant, Investigator and Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
To compare the effect of VR-based preoperative education in lowering pre-operative anxiety, as measured by the Amsterdam Preoperative Anxiety and Information scale ( APAIS score )	Pre intervention Immediately after intervention 24 hrs post intervention

Secondary Outcome

Outcome	TimePoints
To compare the serum cortisol levels in patients receiving VR-based pre-education to those receiving standard pre-op education 24 hrs after intervention.	24 hrs after intervention
To compare the effectiveness of VR-based pre-education in alleviating stress as measured by the Visual Analog Scale (VAS) 24 hrs after intervention.	24 hrs after intervention
To compare the differences in postoperative pain perception among patients who received VR-based pre-educational interventions as compared to those receiving standard pre-op education using the Visual Analog Scale 48 hrs post extubation.	48 hrs post extubation

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

Phase 1/ Phase 2

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

Preoperative anxiety is common among patients undergoing open heart surgery and is associated with adverse psychological and physiological outcomes, including increased perioperative stress, analgesic requirements, and delayed recovery. Patients who suffer from moderate to severe anxiety prior to cardiac surgery experience more pain during post op as compared to patients experiencing mild anxiety.Conventional preoperative education methods may be insufficient in addressing patient fears and improving understanding of the surgical process. VR based distraction videos have been used earlier to decrease preoperative anxiety. Innovation in this study is that we are using virtual reality (VR)–based pre-education to offer an immersive and interactive approach that may enhance patient engagement and reduce anxiety by familiarizing patients with the perioperative environment. This study evaluates the effectiveness of VR-based preoperative education in reducing preoperative anxiety among patients scheduled for open heart surgery. Patients were divided into a control group receiving standard preoperative counseling and an experimental group receiving additional VR-based education. Anxiety levels were assessed using validated anxiety measurement scales before surgery. The outcomes of both groups were compared to determine the impact of VR intervention.