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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  
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 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  
Status 
Not Applicable 
 
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 . 

 

 
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