| CTRI Number |
CTRI/2019/10/021588 [Registered on: 10/10/2019] Trial Registered Prospectively |
| Last Modified On: |
09/10/2019 |
| 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 showing videos to children undergoing eye daycare surgeries for stress reduction |
|
Scientific Title of Study
|
Effect of videodistraction on preoperative anxiety scores in paediatric patients undergoing general anaesthesia in ophthalmic day care procedures: A randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Soumily Bandyopadhyay |
| Designation |
Junior Resident(Post graduate trainee) |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room number 5011, Teaching Block, Department of Anaesthesiology, Pain medicine and Critical Care, All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029, India
New Delhi
DELHI
110029
India |
| Phone |
9836804943 |
| Fax |
|
| Email |
soumilybanerjee@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manpreet Kaur |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room number 5011, Teaching Block, Department of Anaesthesiology, Pain medicine and Critical Care, All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029, India
New Delhi
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
manpreetkaurrajpal@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soumily Bandyopadhyay |
| Designation |
Junior Resident (academic) |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room number 5011, Teaching Block, Department of Anaesthesiology, Pain medicine and Critical Care, All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029, India
New Delhi
DELHI
110029
India |
| Phone |
9836804943 |
| Fax |
|
| Email |
soumilybanerjee@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Pain medicine and Critical Care, All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029, India |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Room number 5011, Teaching Block, Department of Anaesthesiology, Pain medicine and Critical Care, All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029, India |
| 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 Soumily Bandyopadhyay |
All India Institute of Medical Sciences |
Room number 5011, Teaching Block, Department of Anaesthesiology, Pain medicine and Critical Care, All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029, India
New Delhi
DELHI |
9836804943
soumilybanerjee@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee for post graduate research, AIIMS |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Only parental presence |
only parental presence in preoperative area and continued during transport and induction of anaesthesia. |
| Intervention |
Parental presence with videodistraction |
video game/cartoon distraction in pre anaesthetic area and continued during transport and induction of anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1)Children aged 2-8 years
2)ASA physical status 1 or 2
3)Undergoing elective ophthalmic outpatient surgery
4)Atleast one functional eye
|
|
| ExclusionCriteria |
| Details |
1)ASA 3 or 4
2)Syndromic children
3)General exposures>3
4)Children who received preoperative anxiolytic medication like midazolam etc
5)Significant cognitive impairment or developmental delays impairing language or vision
6)Children on psychotropic medications.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare preoperative anxiety using mYPASS score in paediatric patients undergoing ophthalmic procedures under general anaesthesia using video distraction and parental presence with parental presence alone. |
Three timepoint:
1)pre anaesthetic room
2)During transport to operating room
3)After introduction of anaesthetic mask |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare in the two groups:
1)Child fear
2) Emergence delirium
3)Parental satisfaction and anxiety
|
Three timepoints:
1)pre anaesthetic room
2)During transport to operating room
3)After introduction of anaesthetic mask |
|
|
Target Sample Size
|
Total Sample Size="138"
Sample Size from India="138"
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)
|
12/03/2020 |
| 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="2"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomized controlled double blinded trial to study the effect of video distraction on pre-operative anxiety scores(Modified Yale Preoperative anxiety scale) in paediatric patients undergoing general anaesthesia in ophthalmic daycare procedures. |