| CTRI Number |
CTRI/2025/11/097859 [Registered on: 21/11/2025] Trial Registered Prospectively |
| Last Modified On: |
20/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Other |
|
Public Title of Study
|
EFFECTIVENESS OF VIRTUAL REALITY VIDEOS ON PHYSIOLOGICAL PARAMETERS, ANXIETY, STRESS AND DEPRESSION AMONG INTENSIVE CARE UNIT PATIENTS |
|
Scientific Title of Study
|
The efficacy of virtual reality on physiological parameters, anxiety, stress and depression among patients admitted in intensive care unit at tertiary care hospital - 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 |
VVignesh |
| Designation |
student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research Deemed to be University |
| Address |
Hall 11 3rd Floor Department of Medical Surgical Nursing Sri Ramachandra Faculty of Nursing Sri Ramachandra Institute of Higher Education and Research Deemed to be
University Porur Chennai 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9080153669 |
| Fax |
|
| Email |
N1624003@sriher.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
VVignesh |
| Designation |
student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research Deemed to be University |
| Address |
Hall 11 3rd Floor Department of Medical Surgical Nursing Sri Ramachandra Faculty of Nursing Sri Ramachandra Institute of Higher Education and Research Deemed to be
University Porur Chennai 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9080153669 |
| Fax |
|
| Email |
N1624003@sriher.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Maria Mazarrello A |
| Designation |
Lecturer |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research Deemed to be University |
| Address |
Faculty Room 3rd Floor Department of Medical Surgical Nursing Sri Ramachandra Faculty of Nursing Sri Ramachandra Institute of Higher Education and Research Deemed to be University Porur Chennai 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9840186262 |
| Fax |
|
| Email |
mariamazarrello@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research Deemed to be
University Pour Chennai Tamil Nadu 600116
|
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education and Research Deemed to be University |
| Address |
Sri Ramachandra Faculty of Nursing Sri Ramachandra Institute of Higher Education and Research Deemed to be
University Porur Chennai Tamil Nadu 600116
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 Hemalatha R V |
Sri Ramachandra Medical Center |
Department of Critical Care Medicine 4th Floor C4 Room No-3
Chennai
TAMIL NADU |
9952960709
hema.rvasu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Institute of Higher Education and Research (DU) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F411||Generalized anxiety disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
routine care |
After the patient is admitted to the ICU, a baseline pretest will be conducted for the control group on Day 1. Patients in the control group will not receive any virtual reality (VR) session; instead, they will continue with standardized ICU care
(routine care). After this standardized ICU care, Post-test I will be conducted at the same time point as the intervention group. On Day 2 and Day 3, the control group will again receive only standardized ICU care, followed by Post-test II and Post-test III will be conducted for the control group |
| Intervention |
virtual reality video |
After the patient is admitted to the ICU, a baseline pretest will be conducted to the intervention group on Day 1. Once the pretest is completed, the patients will undergo a 15-minute virtual reality (VR) video session using a VR device. The videos will consist of calming, slow-paced nature environments (e.g., forests, beaches, waterfalls, Natural wounders, sunrises and sunset). Immediately after the virtual reality (VR) session, Post-test I will be conducted. On Day 2 and Day 3, the patient will again receive 15-minute virtual reality (VR) video sessions, which will be followed by Post-test II and Post-test III for the intervention group.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Both |
| Details |
Patients age greater than 19 years and less than 65years
conscious oriented patient
Willingness to participate |
|
| ExclusionCriteria |
| Details |
patients who have visual and hearing impairment
Unconscious and intubated patients
Severe mental health disorder
Severe or life - threatening condition |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Virtual Reality intervention is positively impact in physiological parameters and decrease anxiety, depression, and stress levels in ICU patients |
Pre-test- After 24 hours of ICU Admission
Post-test- 1 After 24 hours of ICU Admission
Post-test- 2 After 48 hours of ICU Admission
Post-test- 3 After 72 hours of ICU Admission |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Virtual reality interventions decrease levels of depression, anxiety, and stress, leading to a shorter ICU stay for patients |
Pre-test- After 24 hours of ICU Admission
Post-test- 1 After 24 hours of ICU Admission
Post-test- 2 After 48 hours of ICU Admission
Post-test- 3 After 72 hours of ICU Admission
|
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
01/12/2025 |
| 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="0"
Months="4"
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
|
Purpose: The study aims to evaluate the efficacy of virtual reality in reducing depression, anxiety, stress and improving physiological parameters in comparison with standard intensive care unit (ICU) care. Methods: Study Design: Randomized controlled trial using block randomization to ensure balanced allocation of participants into intervention and control groups. A total of 120 patients will be recruited based on inclusion criteria and randomly assigned into two groups: study group (n = 60) and control group (n = 60). On Day 1, a pre-test will be conducted for both groups. Following this, participants in the study group will receive a 15-minute virtual reality (VR) video session using a VR device, while the control group will continue to receive standard ICU care. Immediately after the intervention, a post-test I will be conducted to both groups. On Day 2 and Day 3, the study group will again receive VR video sessions, whereas the control group will continue with standard care. Subsequently, post-test II and post-test III will be conducted for both groups to evaluate outcomes over time. Proposed Results: The virtual reality intervention is very much useful for ICU patients to reduce the depression, anxiety, stress and gives the positive impact in physiological parameters that reduce the length of ICU stay for the patients. |