| CTRI Number |
CTRI/2024/11/077254 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
14/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Mixed method study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Attitudes, perceptions and experience of parents regarding their presence at induction of anaesthesia |
|
Scientific Title of Study
|
Attitudes perceptions and experience of parents regarding their presence at induction of anaesthesia in Children A Mixed method 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 |
Naitham Dileep |
| Designation |
junior Resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of anesthesia,4th floor,Nehru hospital,Post Graduate Institute of Medical Education and Research,sector 12,chandigarh ,160012
Chandigarh CHANDIGARH 160012 India |
| Phone |
7396989606 |
| Fax |
|
| Email |
dileepnitham@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Naveen Naik B |
| Designation |
Assistant professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of anesthesia,4th floor,Nehru hospital,sector 12,chandigarh ,160012
Chandigarh CHANDIGARH 160012 India |
| Phone |
8872377925 |
| Fax |
|
| Email |
navin_amc@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Naveen Naik B |
| Designation |
Assistant professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of anesthesia,4th floor,Nehru hospital,sector 12,chandigarh ,160012 Department of anesthesia,4th floor,Nehru hospital,sector 12,chandigarh ,160012 Chandigarh CHANDIGARH 160012 India |
| Phone |
8872377925 |
| Fax |
|
| Email |
navin_amc@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive care, 4th Floor, Nehru Hospital, Block A, POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH,SECTOR 12 CHANDIGARH PINCODE 160012,INDIA |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Anaesthesia and Intensive care, 4th floor Nehru hospital, Post Graduate Institute of Medical Education and Research, SECTOR 12, PINCODE 160012 CHANDIGARH 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 Dileep |
Post Graduate Institute of Medical Education and Research |
Department of Anaesthesia and Intensive care,4th floor nehru hospital,Post graduate institute of medical education and research, Sector 12 Chandigarh CHANDIGARH |
07396989606
dileepnitham@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate Institute of Medical Education and Research Chandigarh Institutional Ethics Committee Intramural |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
parents who are willing to participate in study
able to communicate in english/hindi
consented to participate in study |
|
| ExclusionCriteria |
| Details |
parents/caregivers who did not wish to participate in study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To describe the attitudes, perceptions, and experiences of parents concerning PPIA.
|
with in 24hours of post induction
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To describe the role of the following factors in influencing these perceptions surrounding the practice of PPIA in
Profession of parent
Family income (Kuppuswamy scale)
rural/urban
Sibling order
Premedication
Type of anaesthesia (Inhalational/Intravenous induction)
|
with in 24hours of post induction
|
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
01/12/2024 |
| 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
|
Parental presence at anaesthesia induction is defined as the interaction of the child, parent, anaesthesiologist, and peri-operative nurses in the induction room for the duration of anaesthesia induction.4 The protection of one’s offspring is a powerful parental biological instinct, and, unsurprisingly, the separation of children from their parents for medical procedures is stressful for both children and their parents.3 Most children under the age of sixteen are not sufficiently psychologically and intellectually developed to deal with the psycho-trauma associated with pre-operative fears and anxieties, which are exacerbated when they are separated from their parents.Parental presence at anaesthesia induction is defined as the interaction of the child, parent, anaesthesiologist, and peri-operative nurses in the induction room for the duration of anaesthesia induction.4 However, research exploring the attitudes, perceptions, and experiences of parents regarding this practice is limited within the Indian context, which has one of the most religiously and ethnically diverse populations. At our institute, where patients of multiple ethnic groups, speaking different languages coexist. We hypothesize that diverse beliefs will influence the experience a parent has in Operation Theatre regarding PPIA. Furthermore, the results of this study may help form policies guiding PPIA at our institution and may be relevant to other institution in oour country.in this study we will take consent of childrens parents between 2 to 8 years posted for elective surgeries.ocess of we will take parents inside along with patient they are gonna witness entire process of induction of anesthesia. we will conduct interviews of parents within 24 hours of post induction of anesthesia regarding presnce at induction of anesthesia and we willl note their experience. |