| CTRI Number |
CTRI/2024/10/075518 [Registered on: 18/10/2024] Trial Registered Prospectively |
| Last Modified On: |
07/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Virtual reality in reducing peri operative anxiety among women undergoing gynecological surgeries |
|
Scientific Title of Study
|
Virtual reality versus routine care for decreasing perioperative anxiety in women undergoing gynecological surgeries under general anesthesia: 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 Shubha Vijay Nayak |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Department of anesthesiology and critical care, All India Institute of Medical Sciences Bhubaneswar, Sijua, Patrapada
Khordha ORISSA 751019 India |
| Phone |
9449439981 |
| Fax |
|
| Email |
shubhavnayak@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Swagata Tripathy |
| Designation |
Professor & Head |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Department of anesthesiology and critical care, All India Institute of Medical Sciences Bhubaneswar, Sijua, Patrapada
Khordha ORISSA 751019 India |
| Phone |
8763400534 |
| Fax |
|
| Email |
tripathyswagata@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shubha Vijay Nayak |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Department of anesthesiology and critical care, All India Institute of Medical Sciences Bhubaneswar, Sijua, Patrapada
Khordha ORISSA 751019 India |
| Phone |
9449439981 |
| Fax |
|
| Email |
shubhavnayak@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Bhubaneswar, Sijua, Patrapada, Bhubaneswar-751019 |
|
|
Primary Sponsor
|
| Name |
AIIMS Bhubaneswar |
| Address |
Sijua, Patrapada, Bhubaneswar-751019 |
| 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 Shubha Vijay Nayak |
AIIMS Bhubaneswar |
Department of anesthesiology and critical care, AIIMS Bhubaneswar, Sijua, Patrapada, Bhubaneswar-751019 Khordha ORISSA |
9449439981
shubhavnayak@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee All Inda Institute of Medical Sciences Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Routine post operative care |
The patients randomized to control group will be induced via routine general anaesthesia protocol same as that of intervention group and after one hour of regaining complete consciousness after extubation will be assessed for post operative anxiety |
| Intervention |
Virtual reality |
The patients will be randomized by simple randomization into 2 groups VRI group or the control group. Patients in VRI group will be educated and exposed to VR headsets. To the VRI group VR headset will be applied 30 min before shifting to OT and continued till a fixed dose of injection Propofol 1.5-2.5mg/kg is given. After extubation once the patient fully regains consciousness and not drowsy and VR will be re applied.. After one hour post extubation and regaining complete consciousness post operative anxiety will be assessed |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
ASA 1 and 2
Aged 18 to 70 years
Undergoing elective gynecological procedures
Under general anaesthesia |
|
| ExclusionCriteria |
| Details |
ASA grades 3,4,5,6
Refusal for participation
History of psychiatric illness
Patient needing ICU backup
Hearing and vision disabilities
Claustrophobic |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess difference in pre and postoperative anxiety in both groups by State Trait anxiety inventory |
Pre operative anxiety assessed 45 min before shifting to OT.
Post operative anxiety assessed in PACU just before shifting patient to ward |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare mean blood pressure and heart rate at following points-preop, pre and post epidural, after propofol administration at 3 minute time intervals after intubation and in PACU at 5 min, 30 min and 60 min |
After Propofol administration at 3 minute time intervals after intubation for first 3 readings and in PACU at 5 min, 30 min and 60 min |
| To identify percentage of patients denying VR perioperatively |
Perioperative period |
| To compare rescue analgesia required in PACU among groups |
Post operative period |
| To compare patient and anesthetist satisfaction scores among groups |
Post operative period |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
29/10/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Introduction Women often experience higher levels
of anxiety compared to men, extending from the preoperative phase through to
the postoperative period. This gender disparity in preoperative anxiety can be
due to various factors such as biological variances and societal
expectations. Women may face additional
stressors related to reproductive health issues or gender-specific surgeries. Therefore, it is important to address perioperative anxiety to optimize
patient care and improve surgical outcomes Numerous distraction methods have
been found effective in reducing anxiety, alleviating pain, and improving
patient satisfaction. Among these methods, Virtual reality is one.
Virtual reality provides a distraction from stress and pain and gives a sense
of calmness and relaxation, by immersing patients in digitally created
environments. Studies have been conducted to investigate the efficacy of
virtual reality in reducing intraoperative anxiety, but research
examining its effectiveness in addressing postoperative anxiety is currently
lacking. Study methodology
After recruitment, the eligible patients will be randomized by simple randomization
by computer-generated number codes. The allocation to either the Virtual
Reality intervention group or the Control group will
be informed over telephone to the researcher by a third person not
directly involved in the study. The VRI group will be
educated and exposed to VR headsets. They’ll have the option to select videos
from categories like forests, underwater scenes, the solar system, and
religious themes. They will be explained about touch indications for posturing, attaching monitors, cleaning and draping,
and giving injections during preoperative PAC and an education pamphlet will be given.
The night before surgery, patients of both the groups will be advised Tablet
Alprazolam 0.25mg as per institute protocol.
On the day of surgery, preoperative anxiety will be assessed by State-Trait
Anxiety Questionnaire 45 minutes before shifting to the operation
theatre in both groups by a blinded third person. To the VRI group, a VR
headset will be applied 30 minutes before shifting to OT and continued till a
fixed dose of Injection Propofol 1.5 – 2.5mg per kg iv is given. If epidural
anesthesia is administered, it will be accompanied by virtual reality intervention.
After extubation, once the patient fully regains consciousness and is not
drowsy, consent will be taken to reapply the virtual reality headset. If they agree, it will be started.
If not, they will be asked again in the Post-Anesthesia care unit. If they
agree, it will continue for one hour. The used VR is PROCUS One X VR Headset
42mm lenses.
The Control group will
undergo routine perioperative management. Both group patients will
be induced with general anesthesia following the standard method which includes
preoxygenation, pre-induction with fentanyl 2-3mcg per kg, induction with propofol
1.5-2 mg per kg, neuromuscular blocking agent vecuronium 0.1mg per kg, maintenance by
isoflurane MAC 0.9 to 1.0. The Patient will be extubated after administration of
neostigmine and glycopyrrolate to reverse the effect of neuromuscular blockade.
Antiemetic prophylaxis Dexamethasone 0.1mg per kg will be given during
pre-induction and ondansetron 0.1mg per kg will be given at the end of surgery. If
the patient complains of nausea and vomiting in PACU Metoclopramide 10mg will
be given. Injection Tramadol 1 mg per kg in 100ml NS will be given if VAS more than 4.
After one hour of
complete consciousness restoration in the Post-Anesthesia Care Unit,
both study groups will undergo assessment for postoperative anxiety using the
STAI questionnaire and evaluation of patient satisfaction by
a third-party blinded assessor. Additionally, anesthetist satisfaction will be
assessed using a five-point Likert scale. Mean Blood pressure and
heart rate will be measured at the following points: Preop, pre and post
epidural, after propofol administration, after intubation first three readings
at 3-minute intervals, and in PACU at 5 minutes, 30 minutes, and 60 minutes. In PACU injection
Tramadol 1mg per kg in 100ml NS will be given if VAS more than 4.
Anesthetists will
receive training on how to properly apply and adjust the VR headset for the
patient.
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