| CTRI Number |
CTRI/2020/08/027391 [Registered on: 26/08/2020] Trial Registered Prospectively |
| Last Modified On: |
24/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess the effectiveness of instructional module for caregivers of the children undergoing cardiac catheterization on selected outcome variables at advance cardiac centre |
|
Scientific Title of Study
|
A quasi experimental study to assess the effectiveness of instructional module for caregivers of the children undergoing cardiac catheterization on selected outcome variable at advance cardiac centre, PGIMER, Chandigarh |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajkumari |
| Designation |
MSc Nursing student |
| Affiliation |
National institute of nursing education |
| Address |
National Institute of Nursing Education, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8708933258 |
| Fax |
|
| Email |
Rajsohi126@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shruti |
| Designation |
Lecturer |
| Affiliation |
Post Graduate Instittute of Medical Education and Research Chandigarh |
| Address |
National Institute of Nursing Education PGIMER Chandigarh
National Institute of Nursing Education PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8437748011 |
| Fax |
|
| Email |
shrut_cutiepie81@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Rajkumari |
| Designation |
MSc Nursing student |
| Affiliation |
National institute of nursing education |
| Address |
National Institute of Nursing Education, PGIMER, Chandigarh sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8708933258 |
| Fax |
|
| Email |
Rajsohi126@gmail.com |
|
|
Source of Monetary or Material Support
|
| National institute of nursing PGIMER Chandigarh sector 12 |
|
|
Primary Sponsor
|
| Name |
National institute of nursing education PGIMER Chandigarh sector |
| Address |
Room number 208 department of Nursing National Institute of Nursing Education PGIMER 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 |
| Raj kumari |
Cardiology unit |
Advanced Cardiac Centre, PGIMER, Chandigarh, Sector-12
Chandigarh
CHANDIGARH |
8708933258
Rajsohi126@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethic Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
caregivers of the children undergoing cardiac cathetherization |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Instructional module for caregiver |
instructional module contain detailed theoretical knowledge of congenital heart diseases their causes and prevention strategies. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children undergoing cardiac catheterization age <12 years. caregivers of children undergoing cardiac catheterization. care giver who are willing to participate |
|
| ExclusionCriteria |
| Details |
children having bleeding disorder |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decreased anxiety level and satisfaction regarding post procedural care of children and knowledge will improve. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This study will help to reduce the risk of complications among post catheterization children |
1 year |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 1 |
|
Date of First Enrollment (India)
|
28/08/2020 |
| 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="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
|
in this study researcher is going to enroll the caregivers of the children undergoing cardiac catheterization. Their are several complication related with the disease and treatment throughout the complete process of care. now the parents role is very important to understand the condition and provide quality care and support to the children. With the help of this instructional module caregivers will achieve adequate knowledge and attitude to understand the condition and care for the same. |