| CTRI Number |
CTRI/2024/10/075276 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
14/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Virtual reality gorgles] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of virtual reality intervention on anxiety in patients who are on mechanical ventilator |
|
Scientific Title of Study
|
Effect of virtual reality intervention on anxiety in mechanically ventilated patients following neurosurgical procedures: 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 GOBINATH J |
| Designation |
SENIOR RESIDENT ACADEMIC |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
All India Institute of Medical Sciences, Room no:406, Academic building, Department of Anesthesiology and Critical Care, Sijua,Patrapada,Khordha, Orissa Khordha ORISSA 751019 Khordha ORISSA 751019 India |
| Phone |
08098023218 |
| Fax |
|
| Email |
gobigopi@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Swagata Tripathy |
| Designation |
Professor and Head |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
All India Institute of Medical Sciences, Room no:406, academic building, Department of Anesthesiology and Critical Care, Sijua,Patrapada,Khordha, Orissa
Khordha ORISSA 751019
India
Khordha ORISSA 751019 India |
| Phone |
8763400534 |
| Fax |
|
| Email |
anaes_swagata@aiimsbhubaneswar.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Swagata Tripathy |
| Designation |
Professor and Head |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
All India Institute of Medical Sciences, Room no:406, academic building, Department of Anesthesiology and Critical Care, Sijua,Patrapada,Khordha, Orissa
Khordha ORISSA 751019
India
Khordha ORISSA 751019 India |
| Phone |
8763400534 |
| Fax |
|
| Email |
anaes_swagata@aiimsbhubaneswar.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences,Bhubaneswar,Sijua,
Patrapada,Khorda,Orissa-751019 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Sijua,Patrapada,Khordha, Orissa- 751019 |
| 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 Gobinath J |
All India Institute of Medical Sciences,Bhubaneswae |
Room no :406,
Academic building ,
Department of Anesthesiology and critical care,Sijua,Patrapada,Khorda, Orissa Khordha ORISSA |
8098023218
gobigopi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences,Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F411||Generalized anxiety disorder, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Routine ICU care |
Sedation used for anxiety management in mechanically ventilated patients following neurosurgical procedures continued as per routine ICU protocol. |
| Intervention |
Virtual Reality application |
The VR intervention will be administered for a total duration of 15 minutes during the study period . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Mechanically ventilated patients who are awake and can communicate with researchers.
Expected early liberation from the ventilator in the postoperative period.
|
|
| ExclusionCriteria |
| Details |
1.Patients with delirium.
2.History of cybersickness or preexisting symptoms of cybersickness
3. Incision site precluding pain free use of VR visor head strap.
4.Preexisting auditory or visual impairment .
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the anxiety levels in postoperative neurosurgery patients receiving VRI versus routine ICU care. |
The study will begin at the point when the patient regains consciousness as baseline data while on mechanical ventilation and will conclude at the time of extubation . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the anxiety scores in the patients with nasal versus oral endotracheal tube with VRI in first hour of regaining consciousness.
2.To compare the time taken to extubate in patients receiving VRI & routine ICU after regaining consciousness.
3.To compare the sedative use between the two groups from regaining consciousness to extubation.
4.To assess the acceptability of VRI(number of sessions/total duration of sessions requested before extubation) in the intervention group.
5.To determine effects of virtual reality on hemodynamic variables compared to routine care.
|
Secondary outcomes will be evaluated from the time when patient regains consciousness & recorded as baseline data while on mechanical ventilation, until their transfer from the ICU to the ward. |
|
|
Target Sample Size
|
Total Sample Size="170" Sample Size from India="170"
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 |
|
Date of First Enrollment (India)
|
30/10/2024 |
| 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)
|
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
|
Anxiety is a state marked by apprehension, agitation, increased activity, fearful withdrawal, and autonomic activity . Persistent anxiety might make it harder to focus, relax, and rest. Thus, anxiety aggravated by fear causes increased sympathetic activation, increased work of breathing, increased oxygen demand, and myocardial stimulation. Patients experience significant levels of anxiety in the ICU while on mechanical ventilation . Furthermore, excess use of sedations like benzodiazepines for anxiety control is a risk factor for chronic depression and anxiety disorders in patients who have been discharged from the ICU . Patients on mechanical ventilation feel anxious for many reasons, like acute anxiety brought on by dyspnea, discomfort from endotracheal tubes, a sense of helplessness, and fears related to their underlying diseases. Pharmacotherapies like benzodiazepines and opioids are the mainstay of managing anxiety and endotracheal tube intolerance. All pharmacotherapy has unfavorable side effects, alters assessment of consciousness (GCS), delays extubation and increases the risk of developing delirium. Research on ventilator weaning was primarily focused on physiological variables and the use of different modes of ventilation. The impact of mental well-being on ventilator weaning is less investigated. While some alternatives, such as music control, have been explored for anxiety control in ICU patients, there remain few other options for non-pharmacological methods. The use of virtual reality in the ICU reduces anxiety and sedative requirements in non-ventilator patients. We want to explore the feasibility of VR for anxiolysis in patients on mechanical ventilation using a prospective trial. There is no data on the use of VR to reduce anxiety and facilitate extubation in the neurosurgical ICU. We aim to compare the anxiety levels of postoperative neurosurgical patients on a mechanical ventilator receiving VRI versus routine ICU care and its effect on time to extubation . |