| CTRI Number |
CTRI/2025/05/086287 [Registered on: 05/05/2025] Trial Registered Prospectively |
| Last Modified On: |
30/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [QUASI-EXPERIMENTAL , NON-EQUIVALENT GROUP DESIGN] |
| Study Design |
Other |
|
Public Title of Study
|
Improving Family-Centered Care Practices in Pediatric Surgery: A Study on Nurses and Caregivers at AIIMS New Delhi |
|
Scientific Title of Study
|
A Quasi-Experimental Study To Assess The Impact Of Family Centred Care Intervention On The Practices And Attitude Of Nurses And Primary Care Giver In Pediatric Surgery AIIMS New Delhi. |
| Trial Acronym |
FCC(Family Centred Care) |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jai Sachan |
| Designation |
M.Sc Nursing (Pediatric Nursing) Student |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
College Of Nursing All India Institute Of Medical Sciences New Delhi
South
DELHI
110029
India |
| Phone |
8527638771 |
| Fax |
|
| Email |
jaiworkspace5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms. Levis Murry |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
College Of Nursing All India Institute Of Medical Sciences New Delhi
South
DELHI
110029
India |
| Phone |
7838990810 |
| Fax |
|
| Email |
levis.murry@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jai Sachan |
| Designation |
M.Sc Nursing (Pediatric Nursing) Student |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
College Of Nursing All India Institute Of Medical Sciences New Delhi
South
DELHI
110029
India |
| Phone |
8527638771 |
| Fax |
|
| Email |
jaiworkspace5@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jai Sachan |
| Address |
College Of Nursing All India Institute of Medical Sciences New Delhi 110029 |
| 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 |
| Dr Anjan Dhua |
All India Institute of India |
Pediatric Surgery Ward , 6th Floor , MCB , New Delhi , 110029
South
DELHI |
9871568690
dhuaanjan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE ALL INDIA INSTITUTE OF MEDICAL SCIENCES , NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Nurses In Pediatric Surgery Ward and Care Giver of children undergone surgery |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Family centred care Interventions |
The Family-Centered Care (FCC) Intervention Program includes a comprehensive training module for nurses, featuring interactive 30-minute sessions on FCC principles, communication strategies, and family engagement, supported by video-based learning and case scenarios, with reinforcement every four weeks. To aid implementation, job aids such as posters displaying FCC concepts will be placed in wards, and a checklist will be provided for nurses to assess FCC practices weekly for each patient. The practical application of FCC principles will be emphasized through real-time care scenarios and video presentations, ensuring a consistent and structured approach to enhancing family-centered care. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Nurses actively working in pediatric surgery ward during the study period.
2 Caregiver of children admitted for surgery during the study period.
3 The children undergone surgery .
|
|
| ExclusionCriteria |
| Details |
Nurses on long leave more than 15 days in pediatric surgery ward during the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Impact of Family Centred Care Intervention on Practices of Nurses |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Impact of Family Centred Care Intervention on Attitude of Nurses |
4 weeks |
| Attitude of primary care giver towards family centred care |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
01/08/2025 |
| 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="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
|
Title
A Quasi-Experimental Study to Assess the Impact of Family-Centered Care Intervention on the Practices and Attitudes of Nurses and Primary Caregivers in Pediatric Surgery at AIIMS New Delhi. Purpose
The study aims to evaluate the impact of a Family-Centered Care (FCC) intervention on the practices and attitudes of nurses, as well as the attitudes of primary caregivers (parents) in the pediatric surgery ward. Background
Family-Centered Care is a collaborative approach to healthcare that emphasizes partnerships between healthcare providers, patients, and families. Despite its proven benefits, FCC is not widely implemented in Indian pediatric surgery settings, leading to gaps in family involvement, communication, and caregiver satisfaction. Objectives - Assess the impact of FCC intervention on the practices and attitudes of nurses.
- Evaluate the impact of FCC intervention on the attitudes of parents.
- Correlate nurses’ practices and attitudes regarding FCC.
- Identify associations between demographic variables and the impact of FCC intervention.
Methodology Design: Quasi-experimental pretest-posttest study without a control group. Setting: Pediatric surgery ward at AIIMS New Delhi. Participants: Nurses and parents of hospitalized children meeting the inclusion criteria. Sampling Technique: Total enumeration sampling. Intervention: Nurses will receive FCC-focused education sessions, checklists, and posters to reinforce principles of FCC. Data Collection: Sociodemographic data, FCC-related practices, and attitudes will be assessed using structured tools before and after the intervention. Significance
This study addresses the limited implementation of FCC in Indian pediatric surgery units. By enhancing FCC practices, it aims to improve the quality of care, family satisfaction, and outcomes for hospitalized children and their families. |