| CTRI Number |
CTRI/2024/08/073146 [Registered on: 30/08/2024] Trial Registered Prospectively |
| Last Modified On: |
29/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of virtual reality technology in reducing
pre-operative anxiety, stress and anaesthetic
requirement in patients undergoing
laparoscopic cholecystectomy |
|
Scientific Title of Study
|
Role of virtual reality technology in reducing
pre-operative anxiety, stress and anaesthetic
requirement in patients undergoing
laparoscopic cholecystectomy
- A randomised 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 |
Divya |
| Designation |
Junior Resident |
| Affiliation |
Uttar Pradesh University Of Medical Sciences, saifai , etawah |
| Address |
Department of Anaesthesiology, Uttar Pradesh University Of Medical Sciences, saifai , etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
7985092680 |
| Fax |
|
| Email |
wardofthelord@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manoj Kumar |
| Designation |
Professor |
| Affiliation |
UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES , SAIFAI , ETAWAH |
| Address |
Department of Anaesthesiology and Critical Care
Uttar Pradesh University Of Medical Sciences Saifai
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9410854970 |
| Fax |
|
| Email |
lucknow.manoj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Divya |
| Designation |
Junior Resident |
| Affiliation |
Uttar Pradesh University Of Medical Sciences, saifai , etawah |
| Address |
Department of Anaesthesiology, Uttar Pradesh University Of Medical Sciences, saifai , etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
7985092680 |
| Fax |
|
| Email |
wardofthelord@gmail.com |
|
|
Source of Monetary or Material Support
|
| Uttar Pradesh University Of Medical Sciences, saifai , etawah , uttar pradesh , India
PIN : 206130 |
|
|
Primary Sponsor
|
| Name |
Uttar Pradesh University Of Medical Sciences |
| Address |
Room number 329 , Uttar Pradesh University Of Medical Sciences, saifai , etawah , Uttar Pradesh, India
PIN: 206130 |
| Type of Sponsor |
Government 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 Divya |
Uttar Pradesh University Of Medical Sciences |
Department of Anaesthesiology and Department of Surgery , Uttar Pradesh University Of Medical Sciences , Saifai, Uttar Pradesh
Etawah
UTTAR PRADESH |
7985092680
wardofthelord@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Uttar Pradesh University of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K807||Calculus of gallbladder and bile duct without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Simple eye closure |
patients will be asked to simply close their eyes and relax for 15 minutes. |
| Intervention |
VIRTUAL REALITY TECHNOLOGY |
a video will be shown to the patients through the virtual reality box to provide a visual and auditory experience for 15 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 18-40 years posted for elective laparoscopic
cholecystectomy.
2. ASA physical status classification I and II. |
|
| ExclusionCriteria |
| Details |
1. Patient refusal to participate in the study.
2. Having visual or auditory abnormalities.
3. H/o claustrophobia.
4. Chronic alcohol or substance addiction.
5. Motion sickness or vertigo.
6. H/o seizures.
7. Known case of adrenal insufficiency.
8. Cerebrovascular disease.
9. Previous history of any surgery.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To investigate the role of virtual reality in reducing pre operative anxiety levels in patients undergoing laparoscopic cholecystectomy under general anaesthesia using the Amsterdam preoperative anxiety and information scale (APAIS). |
Just before and after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Serum cortisol levels |
just before the intervention and after the intervention . |
| The Bispectral Index value and the corresponding Minimum Alveolar Concentration value |
every 15-minute interval intra-operatively. |
| Post-operative pain will be assessed by using Visual analogue scale (VAS) score |
every 2 hourly, for the next 24 hours |
| Hemodynamic parameters like heart rate, blood pressure and peripheral oxygen saturation |
just before and after the VR box intervention and every 15 minutes intra-operatively. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/09/2024 |
| 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="1"
Months="7"
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
|
More than 80 % of the patients experience pre-operative anxiety which adversely affects the overall comfort and well-being of the patient . The consequent release of catecholamines brings about various physiological and psychological changes such as tachycardia, hypertension , increased sensitivity to pain and ultimately increasing the amount of anaesthetic agents required. This also has a negative impact on post operative recovery of the patient. It has been observed that patients with higher pre-operative anxiety tend to experience more post-operative pain, have delayed wound healing, fluid – electrolyte imbalance and increased risk of infection. Virtual reality is a simulated 3D environment that enables the user to explore and interact with a virtual surrounding in a way that approximates reality as if perceived through the user’s senses. It is proposed that this immersive technology can work as a tool to distract patient’s attention away from the concerns regarding the upcoming surgery. Hence, in this study, we aim to evaluate the role of VR technology in mitigating the pre- operative anxiety and stress levels , hemodynamic parameters and patient satisfaction in patients undergoing surgery under general anaesthesia .. |