| CTRI Number |
CTRI/2022/07/044191 [Registered on: 20/07/2022] Trial Registered Prospectively |
| Last Modified On: |
19/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Process of Care Changes |
| Study Design |
Other |
|
Public Title of Study
|
A pre-experimental study to assess the effectiveness of a “Nurse Guided Interventional Package†for general care on weight gain and infection among scald burn children and their caregivers |
|
Scientific Title of Study
|
A pre-experimental study to assess the effectiveness of a “Nurse Guided Interventional Package†for general care on selected outcome variables among scald burn children and their caregivers in selected unit of Plastic surgery of PGIMER, Chandigarh (2021-2023). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dinesh Saini |
| Designation |
M Sc Nursing student |
| Affiliation |
Postgraduate Institute of Medical Education and Research, Chandigarh |
| Address |
Room no 208, National Institute of Nursing Education, PGIMER Chandigarh-160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8437632163 |
| Fax |
|
| Email |
saini78dinesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rupinder Kaur |
| Designation |
Tutor |
| Affiliation |
Postgraduate Institute of Medical Education and Research, Chandigarh |
| Address |
Room no 116,National Institute of Nursing Education, PGIMER Chandigarh-160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9878033748 |
| Fax |
|
| Email |
kauramanjot40@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rupinder Kaur |
| Designation |
Tutor |
| Affiliation |
Postgraduate Institute of Medical Education and Research, Chandigarh |
| Address |
Room no 116,National Institute of Nursing Education, PGIMER Chandigarh-160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9878033748 |
| Fax |
|
| Email |
kauramanjot40@gmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Medical Education and Research, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Postgraduate Institute of medical education and research chandigarh |
| Address |
sector 12, Chandigarh |
| 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 |
| Dinesh Saini |
Plastic Surgery units |
PGIMER sector 12 Chandigarh
Chandigarh
CHANDIGARH |
8437632163
saini78dinesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER CHANDIGARH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: T312||Burns involving 20-29% of body surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
Nurse guided interventional package |
Information booklet on general care of scald burn patient will be disbursed with instructions. The caregivers will be contacted at admission and tell about care of scald burn child . After 7 days , 14 days , 21 days and 30 days will be monitored for general care and weight gain. finally a post test will be taken at 30 days for assess the effectiveness of booklet. Total duration of intervention will be 30 days. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
14.00 Year(s) |
| Gender |
Male |
| Details |
scald burn child age up to 6 month to 14 years
total burn surface area is not more than 25 percent |
|
| ExclusionCriteria |
| Details |
ventilator supported child
mentally ill burn patient
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Weight Gain
Infection control
prevention of complication
Early healing |
we will assess outcome at 14 days, 21 days, and 30 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
weight gain
wound healing |
we will assess secondary outcome at 21 and 30 days. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
25/07/2022 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A pre-experimental study to assess the effectiveness of a “Nurse Guided Interventional Package†for general care on selected outcome variables among scald burn children and their caregivers in selected unit of Plastic surgery of PGIMER, Chandigarh (2021-2023). Objectives To identify the causes & problems of the scald burn children in selected unit of plastic surgery, PGIMER, Chandigarh. To develop and implement a “Nurse Guided Interventional Package†for general care and prevention of complications in scald burn children in selected unit of plastic surgery, PGIMER, Chandigarh. To assess the effectiveness of “Nurse Guided Interventional Package†for general care of burn on selected outcome variable in scald burn children in selected unit of plastic surgery, PGIMER, Chandigarh. To identify the problem of the parents of scald burn children in selected unit of plastic surgery, PGIMER, Chandigarh. |