| CTRI Number |
CTRI/2025/06/089149 [Registered on: 19/06/2025] Trial Registered Prospectively |
| Last Modified On: |
18/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [nurse led home care package for caregivers of children with Hydrocephalus] |
| Study Design |
Other |
|
Public Title of Study
|
Improving Care at Home,a A Nurse-Led Program for Families of Children with Hydrocephalus. |
|
Scientific Title of Study
|
A Randomized controlled trial to assess the effectiveness of “Nurse led home care package for caregivers of children with hydrocephalus” on selected outcome variables among children with Hydrocephalus and their caregivers attending Pediatric surgery units at PGIMER,Chandigarh,2024-26 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suman Pokhriya |
| Designation |
M.Sc nursing student |
| Affiliation |
National Institute Of Nursing Education |
| Address |
Room no: 208, Department Of National Institute Of Nursing Education,PGIMER,Chandigarh,160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9915838978 |
| Fax |
|
| Email |
sumanpokhriya2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monaliza |
| Designation |
Associate Professor |
| Affiliation |
National Institute Of Nursing Education |
| Address |
Room no: 318, Department of National Institute Of Nursing Education,PGIMER,Chandigarh,160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914477603 |
| Fax |
|
| Email |
monaliza.mittal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Anupama Choudhary |
| Designation |
Tutor |
| Affiliation |
National Institute Of Nursing Education |
| Address |
Room no: 221, Department Of National Institute Of Nursing Education,PGIMER,Chandigarh,160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9888961771 |
| Fax |
|
| Email |
anuk308@gmail.com |
|
|
Source of Monetary or Material Support
|
| Advanced Pediatric Centre Ward 6C, PGIMER, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Suman Pokhriya |
| Address |
National Institute Of Nursing Education,PGIMER,Chandigarh,160012 |
| 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 Monaliza |
Pediatric Surgery Unit, Advanced Pediatric Centre |
Ward 6 C & OPD, Department Of Advanced Pediatric Centre, PGIMER, Chandigarh, 160012
Chandigarh
CHANDIGARH |
9914477603
monaliza.mittal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(Intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G919||Hydrocephalus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nurse led home care package for caregivers of children with Hydrocephalus |
Nurse led home care package include educating caregivers about the disease condition,skill building of caregivers in providing care to Hydrocephalus child at home |
| Comparator Agent |
Routine care & assessment |
routine head circumference assessment and routine care |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
children diagnosed with Hydrocephalus and their caregivers
willing to participate in the study |
|
| ExclusionCriteria |
| Details |
critically ill child
child greater then 12 years |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| frequency of hospitalization,Incidence of complications,Caregivers burden,Caregivers stress,Caregivers skills,Quality of life of caregivers |
baseline, immediately after intervention, follow up after 1 week and 3 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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 2 |
|
Date of First Enrollment (India)
|
01/07/2025 |
| 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
|
In This study i am going to develop and implement a nurse led home care package for caregivers of children with Hydrocephalus and evaluate its effectiveness on selected outcome variables for caregivers and children with Hydrocephalus.The nurse led home care package includes education to caregivers about Hydrocephalus,their skill building in providing care to Hydrocephalus child,assessment of early signs of complications,diet and follow up |