| CTRI Number |
CTRI/2025/10/095608 [Registered on: 06/10/2025] Trial Registered Prospectively |
| Last Modified On: |
14/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Structured Teaching Programme to the family caregiver of neonate] |
| Study Design |
Other |
|
Public Title of Study
|
structure teaching programme for caregivers in caring neonates |
|
Scientific Title of Study
|
“Effect of Structured Teaching Program on knowledge in caring of
neonates among family caregivers of neonates admitted at a tertiary care center in western
Rajasthan |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SAMUEL |
| Designation |
PG NURSING STUDENT |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR, RAJASTHAN |
| Address |
Department Child Health Nursing, Basni phase 2, gate no. 4, Room no 107 ALL INDIA INSTITUTE OF MEDICAL SCIENCES Jodhpur, COLLEGE OF NURSING, Rajasthan 342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
08477931903 |
| Fax |
|
| Email |
samuelraj175134@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MUKESH CHANDRA SHARMA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR |
| Address |
Department Child Health Nursing, Basni phase 2, gate no. 4, Room no 107 ALL INDIA INSTITUTE OF MEDICAL SCIENCES Jodhpur, COLLEGE OF NURSING, Rajasthan 342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9779534307 |
| Fax |
|
| Email |
sharmamukeshchandra0704@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MUKESH CHANDRA SHARMA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR |
| Address |
Department Child Health Nursing, Basni phase 2, gate no. 4, Room no 107 ALL INDIA INSTITUTE OF MEDICAL SCIENCES Jodhpur, COLLEGE OF NURSING, Rajasthan 342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9779534307 |
| Fax |
|
| Email |
sharmamukeshchandra0704@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR COLLEGE OF NURSING 342005 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [PG PARTIAL REQUIREMENT] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR MUKESH CHANDRA SHARMA |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR |
OPD THIRD FLOOR, ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR, HEAVY INDUSTRIAL AREA BASNI PHASE 2 342005
Jodhpur
RAJASTHAN |
9779534307
sharmamukeshchandra0704@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee AIIMS, Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Family caregivers on neonates |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
one group pretest posttest |
no comparator agent |
| Intervention |
Structured Teaching Programme to the family caregivers in caring neonates |
Session 1: Structured teaching will be on prevention from hypothermia, KMC, and
breastfeeding. The content will be delivered using PowerPoint presentations and
interactive discussions. Timing will be after routine care in morning.
Session 2: Structured teaching will be on prevention of infections and identification of
neonatal danger signs. These topics will also be covered using PowerPoint presentations
and interactive discussions. Timing will be after lunch.
Each teaching session will last for approximately 45-60 minutes.
One week after the structured teaching program, a post-test will conduct to evaluate the
improvement in the caregivers knowledge about neonatal care. total duration of this intervention will be 6 weeks
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria- Family caregiver with the neonates:
a) Admitted in the NICU during the study period.
b) Admitted in the NICU who can read and understand Hindi/English language.
c) Who are willing to participate in the structure teaching program.
d) Who will be available at least for 1 week after the intervention.
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria: Family caregivers with neonates:
a) Admitted in NICU for more than 1 month.
b) Family caregiver with psychiatric disorders.
c) Who have attended educational program on care of neonates. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of the present study will be the improvement in knowledge level of family caregivers regarding neonatal care following the implementation of a structured teaching program. |
primary outcome of the study will be assessed after one week of intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| the study will determine whether demographic variables such as age, education, occupation, & previous exposure to neonatal care influence knowledge levels. Thus, the outcome reflects both effectiveness of the intervention & its association with caregiver characteristics. |
after one week of intervention the post test will be conducted & its association with caregiver characteristics will be assessed |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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)
|
18/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
18/10/2025 |
| 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 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
|
The study aims to evaluate the effectiveness of a structured teaching program on knowledge regarding neonatal care among family caregivers of neonates admitted at a tertiary care center in Western Rajasthan. A pre-experimental one-group pre-test post-test design will be used. Knowledge levels of caregivers will be assessed before and after the intervention using a structured questionnaire. The program will focus on essential aspects of neonatal care such as kangaroo mother care, breastfeeding, hand hygiene, prevention of hypothermia, and recognition of danger signs. The findings are expected to enhance caregiver knowledge, contributing to improved neonatal health outcomes. |