| CTRI Number |
CTRI/2024/06/069289 [Registered on: 20/06/2024] Trial Registered Prospectively |
| Last Modified On: |
05/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of 3D video by special virtual reality headset for reduction of anxiety in children during general anaesthesia for surgery |
|
Scientific Title of Study
|
Effect of immersive virtual reality vs intranasal midazolam on preoperative anxiety in children undergoing inhalation induction of anaesthesia: A prospective, randomised, controlled study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Renu Sinha |
| Designation |
Professor |
| Affiliation |
Department of Anaesthesiology, Pain medicine and Critical care |
| Address |
Room no 376, 3rd floor, Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi
New Delhi DELHI 110029 India |
| Phone |
9810305156 |
| Fax |
|
| Email |
renusinha@aiims.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Renu Sinha |
| Designation |
Professor |
| Affiliation |
Department of Anaesthesiology, Pain medicine and Critical care |
| Address |
Room no 376, 3rd floor, Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi
New Delhi DELHI 110029 India |
| Phone |
9810305156 |
| Fax |
|
| Email |
renusinha@aiims.edu |
|
Details of Contact Person Public Query
|
| Name |
Poojan Bhatt |
| Designation |
Junior resident |
| Affiliation |
Department of Anaesthesiology, Pain medicine and Critical care |
| Address |
Department of Anaesthesiology, Pain medicine and Critical care, AIIMS, New Delhi Green Park main, new delhi New Delhi DELHI 110029 India |
| Phone |
9924036171 |
| Fax |
|
| Email |
dr.poojanbhatt@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
AIIMS, NEW DELHI |
| Address |
Department of Anaesthesiology, Pain medicine and Critical care, AIIMS, New Delhi, 110029 |
| 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 Renu Sinha |
AIIMS |
Room no 376, 3rd floor, Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi South DELHI |
9810305156
renusinha@aiims.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Immersive Virtual Reality |
We will show videos in a VR headset to children 10 minutes before anaesthesia till induction of anaesthesia to reduce their preoperative anxiety |
| Comparator Agent |
Intranasal Midazolam |
Midazolam is a benzodiazepine. It will be administered intranasally to children 20 minutes prior to induction of anaesthesia to reduce their preoperative anxiety |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
ASA PS: I,II
surgery under general anaesthesia |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of immersive virtual reality (IVR) with intranasal midazolam on change in the preoperative anxiety (mYPAS) at inhalational induction of anaesthesia |
From 20 minutes before surgery till induction of anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To compare preoperative anxiety during shifting from preoperative room to operation theatre (OT)
2)To compare the mask acceptance between both groups.
3)To compare the ease of induction between both groups.
4)To compare the satisfaction of parent between both groups. |
1. 20 minutes before induction of anaesthesia in the preoperative room
2.10 minute before induction of anaesthesia in the preoperative room
3. 5 minutes before induction patient during shifting from preoperative room to the operation theatre
4. at the time of induction of anaesthesia |
|
|
Target Sample Size
|
Total Sample Size="112" Sample Size from India="112"
Final Enrollment numbers achieved (Total)= "112"
Final Enrollment numbers achieved (India)="112" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
22/07/2024 |
| Date of Study Completion (India) |
29/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
29/09/2025 |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Preoperative anxiety is very common
in children which can lead issues at induction of anaesthesia and gives a
traumatic experience to the child and dissatisfaction among parents. Various pharmacological and
non-pharmacological methods have been used to decrease the preoperative anxiety
of the child. Among pharmacological methods, drugs such as midazolam, clonidine,
and dexmedetomidine have been used via various routes. However, sedatives drugs
may lead to some side effects. Non-pharmacological methods are based mostly on
distraction tactics. These include merely talking to the child, or use of audio
rhymes, cartoon videos etc. Immersive virtual reality (IVR) is the latest development in technology
of such kind and children seem to adapt to it quickly too. Hence we planned
this study to evaluate the effect of IVR on decreasing the preoperative anxiety
in children in OT with primary aim to compare the effect
of immersive virtual reality (IVR) with intranasal midazolam on change in the preoperative anxiety at
inhalational induction of anaesthesia After pre-anaesthetic check-up a day
before surgery, aim and methodology of the study will be informed to parents
and children above the age of 6 years and informed consent will be obtained.
Child’s anxiety score (mYPAS) (Tp) will be noted. In the same visit, the VR
headset will be checked for proper fitting. The child will choose his/her
favourite video. On the day of surgery, the child will
be randomised into group V or group M. Child’s mYPAS will be noted in the
preoperative room. In group V, selected video via IVR headset will be played in the preoperative
room and he/she will be shifted to OT with the headset on and induction of
anaesthesia will be done with face mask and inhalational agents while the child
is watching the video via headset.In case of group M, 20 minutes prior
to shifting to the OT, 0.3 mg/kg midazolam will be spayed into one nostril or
divided doses into both nostrils. The child will be transferred to OT on a
trolley and induction of anaesthesia will be done, with face mask and
inhalational agents. In both groups, a parent or guardian
will accompany the child to the OT according to the hospital policy.
The following steps will be common to
both the groups. mYPAS scores will be noted a day before in the ward (Tp),
before the initiation of intervention(T0), in the preoperative room at 10
minutes after intervention (T1), the time of transport to OT (T2) and during
the induction of anaesthesia (T3). Standard ASA monitors will be attached &
inhalational induction will be done with incremental increase in sevoflurane
concentration in 100% O2, with an appropriately sized face mask. Assessment of
Induction compliance checklist (ICC) and Mask acceptance score (MAS) will be
done and noted. Insertion of IV cannula will be done once adequate depth of
anaesthesia is achieved. Rest of the anaesthesia management including airway
management will be at the discretion of the attending anaesthesiologist.
Parent’s satisfaction will be assessed after induction of anaesthesia. |