| CTRI Number |
CTRI/2024/10/074727 [Registered on: 04/10/2024] Trial Registered Prospectively |
| Last Modified On: |
04/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE |
| Study Design |
Other |
|
Public Title of Study
|
An study to know about the satisfaction of the parents of the children undergoing MRI procedure under Anesthesia care |
|
Scientific Title of Study
|
A prospective observational study to assess the level of parental satisfaction with periprocedural anesthesia care in the pediatric population undergoing MRI procedure. |
| 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 Pradeeshya Parthiban |
| Designation |
Junior resident |
| Affiliation |
Christian Medical College,Vellore |
| Address |
7th Floor,Anesthesia office
New paul brand building
CMC,Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
9677611060 |
| Fax |
|
| Email |
pradeeshyaparthiban1609@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smitha Elizabeth George |
| Designation |
Professor |
| Affiliation |
Christian Medical College,Vellore |
| Address |
7th Floor,Anesthesia office
New paul brand building
CMC,Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
9655820582 |
| Fax |
|
| Email |
smitha.lizgeorge@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Smitha Elizabeth George |
| Designation |
Professor |
| Affiliation |
Christian Medical College,Vellore |
| Address |
7th Floor,Anesthesia office
New paul brand building
CMC,Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
9655820582 |
| Fax |
|
| Email |
smitha.lizgeorge@gmail.com |
|
|
Source of Monetary or Material Support
|
| christian medical college fluid research fund
Christian Medical College,Vellore
Tamil Nadu
632002
India |
|
|
Primary Sponsor
|
| Name |
Christian medical college Fluid research fund |
| Address |
Ethics Committee,Office of Research,1st Floor,Carman block,Christian Medical College
Vellore
Tamil Nadu-632002 |
| Type of Sponsor |
Private 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 Pradeeshya Parthiban |
Christian Medical College,Vellore |
MRI HOLDING BAY/Recovery Room -12
Department of Radiology
Christian Medical College, IDA Scudder Rd, Vellore, Tamil Nadu 632004
Vellore
TAMIL NADU |
9677611060
pradeeshyaparthiban1609@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUITIONAL REVIEW BOARD(IRB)OFFICE OF RESEARCH CHRISTIAN MEDICAL COLLEGE VELLORE,INDIA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
parents of children below 12 years undergoing MRI |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
We will be including the parents of all the children less than 12 years of age who are scheduled for elective MRI PROCEDURE
And Upper limit is upto12 years.
|
|
| ExclusionCriteria |
| Details |
We will be excluding the following:
-Parents who are not willing to participate.
-Children who are undergoing EMERGENCY MRI.
-Parents who cannot read and write.
-Children above 12 years of age. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Percentage of parents who have satisfaction score of 3 and above in all
the three domains studied (physical comfort, emotional aspect, information provision).
|
one year
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Correlation between socio-demographic
characteristics and level of satisfaction will be studied. The variables that can
affect level of satisfaction like, age of the child, level of education of the parents, occupation type, previous anesthesia experience and perioperative
experience will be analyzed. |
one year |
|
|
Target Sample Size
|
Total Sample Size="266"
Sample Size from India="266"
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)
|
15/10/2024 |
| 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="1"
Months="0"
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
|
This prospective cross-sectional study will be carried out in the holding bay of MRI procedure room of the Christian Medical College. As a first step, a content validated,feasible and reliable questionnaire will be systematically developed and validated following psychometric principles of validation. The first part of the questionnaire will address the socio-demographic details of the parents and information of periprocedural care. The second part of the questionnaire will have satisfaction questions addressing the following domains: physical comfort,emotional support, and information provision.The questionnaire will be administered to 266 parents of children undergoing MRI under Anaesthesia. Inclusion criteria will be parents of all children less than 12 years scheduled for elective MRI procedure under Anaesthesia. After explaining the purpose and intention of study in explanatory note, parents will be requested to fill the written questionnaire in the holding bay outside the MRI room. Likert four-point scale is offered to the parents tochoose for scoring each question. Questionnaires collected back will be evaluated for scores of each item of the domain and the overall satisfaction score will also be analysed. Our aim is to assess the level of parental satisfaction with the periprocedural anaesthesia services and identify the areas of improvement. Correlation of level of satisfaction with socio-demographic variables will be performed.The conclusions drawn will help address the parents concerns about anaesthesia care when children are scheduled for MRI procedure. |