| CTRI Number |
CTRI/2026/02/103264 [Registered on: 06/02/2026] Trial Registered Prospectively |
| Last Modified On: |
05/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Educational intervention] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of nurse led education on homecare management among caregivers of patients after brain surgery |
|
Scientific Title of Study
|
Effectiveness of Nurse Led Educational Intervention on knowledge and care compliance rate regarding homecare management among primary caregivers of patients who underwent Decompressive Craniectomy at NIMHAN. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Fiona Mariola DMello |
| Designation |
MSc Student |
| Affiliation |
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEURO SCIENCES |
| Address |
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEURO SCIENCES
Department of Nursing
Bengaluru
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEURO SCIENCES
Department of Nursing
Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
9844618231 |
| Fax |
|
| Email |
fionarolwin@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gopichandran L |
| Designation |
Assistant Professor |
| Affiliation |
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEURO SCIENCES |
| Address |
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEURO SCIENCES
Department of Nursing
Room No 6
Bengaluru
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEURO SCIENCES
Department of Nursing
Room No 6
Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
8130930287 |
| Fax |
|
| Email |
pravigopi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gopichandran L |
| Designation |
Assistant Professor |
| Affiliation |
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEURO SCIENCES |
| Address |
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEURO SCIENCES
Department of Nursing
Room No 6
Bengaluru
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEURO SCIENCES
Department of Nursing
Room No 6
Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
8130930287 |
| Fax |
|
| Email |
pravigopi@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Mental Health and Neuro sciences (NIMHANS), Bengaluru |
|
|
Primary Sponsor
|
| Name |
not applicable |
| Address |
not applicable |
| Type of Sponsor |
Other [Non funded student thesis] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| not applicable |
not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gopichandran L |
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEURO SCIENCES Bengaluru |
Neurosurgery wards
neurosurgery department
Bangalore
KARNATAKA |
8130930287
pravigopi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMHANS Institutional Sub Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Caregivers of the patients with craniectomy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nurse Led Educational Intervention |
Intervention includes individual caregiver education through PPT and distribution of Leaflet |
| Comparator Agent |
Routine Discharge advice in the ward at the time of discharge |
Routine Discharge advice in the ward at the time of discharge |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Primary Care givers of age equal or more than 18 years
Primary Care givers of all gender who are directly involved in patient care both at hospital and home for at least 2 months
Primary care givers who can speak English, Hindi and Kannada language.
|
|
| ExclusionCriteria |
| Details |
Primary care givers ofprolonged hospital stay patients
Unknown patients that is patient who do not have care giver with them
Patient’s primary caregivers who have undergone similar type of structured teaching
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improved Knowledge
and Care compliance regarding home care management after administering nurse led educational intervention to the experimental group on the day of discharge. This will be assessed by the post test conducted after 10 days of discharge. |
Improved Knowledge and Care compliance of the experimental group who received intervention and the knowledge of control group who got routine insturuction will be reassessed by the investigator after 10 days of discharge. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicablre |
Not applicablre |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
16/02/2026 |
| 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="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 proposed study assess the effectiveness of Nurse Led Educational Intervention on knowledge and care compliance rate regarding the homecare management among primary caregivers of patient who underwent Decompressive Craniectomy. The study planed to include a quasi experimental study design with experimental and control group. study subjects will be recruited through non probability convenience sampling. the experimental group knowledge will be assessed by a structured questionnaire and intervention will be provided and a care compliance log book will be distributed on the day of discharge. The control group will receive routine discharge teaching at the time of discharge and a care compliance log book will be given to the primary caregivers. post test will be conducted after 10 days of discharge in the OPD during the follow up visit. |