| CTRI Number |
CTRI/2025/10/095614 [Registered on: 06/10/2025] Trial Registered Prospectively |
| Last Modified On: |
04/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of Nurse-Led Interventions on Caregivers’ Knowledge, Skills, and Feeding Complications in Children Discharged with a Nasogastric Tube |
|
Scientific Title of Study
|
Effect of Nurse-Led Interventions on Knowledge and Skills of Caregivers and Incidence of Feeding Complications among Children Discharging with a Nasogastric Tube: A Quasi-Experimental 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 |
Ms Yogita Chaudhary |
| Designation |
M.Sc.Nursing Student |
| Affiliation |
AIIMS JODHPUR |
| Address |
Room no. 315, Old girls hostel no. 3 ,ALL INDIA INSTITUTE OF MEDICAL SCIENCES, Basni Industrial Area, Phase-2,
Jodhpur - 342005,
Rajasthan, India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9610768845 |
| Fax |
|
| Email |
yogitachaudhary04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Remiya Mohan |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS JODHPUR |
| Address |
Room no. 101, 1st floor, College of Nursing, ALL INDIA INSTITUTE OF MEDICAL SCIENCES Basni Industrial Area, Phase-2 Jodhpur-342005,
Rajasthan, India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003991316 |
| Fax |
|
| Email |
remiya1986@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suresh K Sharma |
| Designation |
Principal cum Professor |
| Affiliation |
AIIMS JODHPUR |
| Address |
Room no. 101, Ground floor, College of Nursing, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, Basni Industrial Area Phase-2
Jodhpur - 342005,
Rajasthan, India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8475000293 |
| Fax |
|
| Email |
sharmask@aiimsjodhpur.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Jodhpur, Rajasthan 342005, India |
|
|
Primary Sponsor
|
| Name |
Non- sponsored |
| Address |
Non-sponsored |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Non sponsored |
Non-sponsored |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Yogita Chaudhary |
AIIMS, JODHPUR |
PICU, Pediatric Ward and OPD, All India Institute of Medical Sciences, Jodhpur
Jodhpur
RAJASTHAN |
9610768845
yogitachaudhary04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS, Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NIL |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nurse-Led Structured Educational Intervention on Nasogastric (NG) Tube Feeding and Care for Caregivers of Pediatric Patients |
The intervention is a structured nurse-led discharge education program for caregivers of children with nasogastric (NG) tubes. It is delivered in small groups through discussion, demonstration, and return demonstration using PowerPoint, videos, and images. Content includes introduction to NG tube feeding, preparation (hand hygiene, cleaning utensils, feed preparation, confirming tube placement), and the stepwise feeding procedure with emphasis on positioning, aspiration, flushing, and prevention of complications. Caregivers then perform return demonstration, evaluated by an independent observer using a checklist. Each session lasts 20 minutes. Pamphlets are provided during follow-up to reinforce learning and support continued safe home practice. |
| Comparator Agent |
Routine Care for NG Tube Feeding |
Caregivers in the control group will receive the standard hospital care and instructions routinely provided by the nursing staff. This includes basic guidance on NG tube feeding, hygiene, and general care without the structured nurse-led educational intervention. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Caregivers of children
Discharging with NG tube feeding
Between the age group of 1 to 12years
Scheduled for follow up
Available during data collection
Who are willing to participate
Who can understand English or Hindi
|
|
| ExclusionCriteria |
| Details |
Children who are at end-of-life care.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Knowledge & skills of caregivers on NG tube feeding |
1. Baseline 0 week pre-test 3rd day of NG tube insertion – assess knowledge and skills and complications
2. At discharge 2 week assess knowledge and skills and complications
3. At 1 weeks after discharge assess for complications |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of NG tube feeding complications |
At discharge, 1-week follow-up (OPD or telephonic) |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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 3 |
|
Date of First Enrollment (India)
|
15/10/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Effect of nurse-led interventions on knowledge, skills
of caregivers, and incidence of feeding complications among children discharged
with a nasogastric tube – A Quasi-Experimental Study
This study evaluates the effectiveness of
nurse-led interventions on caregivers’ knowledge, skills, and the incidence of
feeding complications among children discharged with a nasogastric (NG) tube.
NG tube feeding is vital for children with oral feeding difficulties, but
improper management can lead to complications such as overfeeding,
underfeeding, aspiration, tube misplacement, and inadequate nutrition,
increasing morbidity and hospital readmissions.
A quasi-experimental design with a non-equivalent
control group approach will be used. The study includes 72 caregivers of
children aged 1–12 years discharged with an NG tube from the pediatric
inpatient department of AIIMS Jodhpur. Participants will be assigned to either
the intervention group, receiving a structured nurse-led intervention on
feeding techniques, tube care, and complication prevention, or the control
group, receiving routine care. NG feeding complications will be assessed before
providing nurse-led intervention, at discharge and at first follow up. Data
will be collected by direct observation and structured interviews.
The study objective to compare pre-test and
post-test caregiver knowledge and skills, assess feeding complications, and find
correlations between caregiver competence and feeding outcomes. Inclusion
criteria include caregivers of children aged 1–12 years, available for
follow-up, and proficient in English or Hindi. Caregivers of children who are
at end-of-life care will be excluded.
It is expected that nurse-led discharge
interventions will enhance caregivers’ knowledge and skills, reducing feeding
complications and hospital readmissions. The study highlights the importance of
structured education in discharge protocols, promoting safe home-based NG tube
feeding and better pediatric health outcomes. Findings may contribute to
improving caregiver preparedness and optimizing pediatric enteral feeding
practices. |