| CTRI Number |
CTRI/2021/05/033486 [Registered on: 07/05/2021] Trial Registered Prospectively |
| Last Modified On: |
30/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
A study to assess the effect of health education regarding care of infants after cardiac surgery on knowledge ,confidence, level of satisfaction of parents and selected patient care outcomes at AIIMS, New Delhi. |
Scientific Title of Study
Modification(s)
|
A study to assess the effect of multi-component intervention programme regarding care of infants after congenital heart surgery on knowledge, confidence ,level of satisfaction of parents and selected patient care outcomes at AIIMS, New Delhi. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dhanya V A |
| Designation |
MSc Nursing Student |
| Affiliation |
AIIMS,New Delhi |
| Address |
College of Nursing, AIIMS, New Delhi
South West
DELHI
110029
India |
| Phone |
9910358609 |
| Fax |
|
| Email |
dhanuasok@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rimple Sharma |
| Designation |
Associate Professor |
| Affiliation |
AIIMS,New Delhi |
| Address |
College of Nursing, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
9953088485 |
| Fax |
|
| Email |
reemapawankumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dhanya V A |
| Designation |
MSc Nursing Student |
| Affiliation |
AIIMS,New Delhi |
| Address |
College of Nursing, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
9910358609 |
| Fax |
|
| Email |
dhanuasok@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Science, New Delhi |
|
|
Primary Sponsor
|
| Name |
Dhanya V A |
| Address |
College of Nursing, AIIMS, New Delhi |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Dhanya V A |
AIIMS, New Delhi |
Cardiothoracic wards(CT4,CT5,CT6)
South
DELHI |
9910358609
dhanuasok@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Multi-component intervention
programme |
Multi-component intervention programme include information and training to parents of infants regarding home care management after cardiac surgery. It includes incision care, diet, activities of daily living, medication administration, immunization, prevention of infection, detection of complication, monitoring milestones and importance of follow up.30 minutes 3 day teaching and supervision session before discharge from hospital.
|
|
Inclusion Criteria
Modification(s)
|
| Age From |
0.00 Day(s) |
| Age To |
12.00 Month(s) |
| Gender |
Both |
| Details |
For infants
1.Infants aged below 12 months.
2.Infants who have undergone congenital heart surgery at AIIMS, New Delhi
3.Infants who are hemodynamically stable
For parents
1.Who are willing to participate
2.Who are able to understand Hindi or English
|
|
| ExclusionCriteria |
| Details |
For infants
1.Infants with any other chronic diseases other than congenital heart diseases.
2.Infants with syndromic diseases
For parents
1.Parents who cannot follow instruction
2.Parents having another child who underwent congenital heart surgery
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Improvement of Knowledge, confidence and level of satisfaction of parents regarding care of infant after congenital heart surgery. |
1 month after discharge from hospital |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Improvement in selected patient care outcomes (nutritional status, frequency of required medical /nursing services)among infants after congenital heart surgery |
1 month after discharge from hospital |
|
Target Sample Size
Modification(s)
|
Total Sample Size="33"
Sample Size from India="33"
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)
Modification(s)
|
03/08/2021 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is "A study to assess the effect of multi-component intervention programme regarding care of infants after congenital heart surgery on knowledge,confidence ,level of satisfaction of parents and selected patient care outcomes at AIIMS,New Delhi".Data collection will start from august 2021 to december 2021.Data analysis will be done using appropriate descriptive and inferential statistics. |