| CTRI Number |
CTRI/2020/05/025063 [Registered on: 06/05/2020] Trial Registered Prospectively |
| Last Modified On: |
09/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Nurse Led Counselling Intervention for children with cerebral visual impairment |
|
Scientific Title of Study
|
A pre experimental study to assess the impact of culturally appropriate and theoretically driven Nurse Led Counselling Intervention given to parents of children with Cerebral Visual Impairment (CVI) on adherence to eye activities attending Advanced Eye Centre at PGIMER, Chandigarh,2019-21 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sonam Dhiman |
| Designation |
Msc Nursing |
| Affiliation |
PGIMER |
| Address |
Room no 208, Department of National Institute of Nursing Education PGIMER SEC-12 Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8178686448 |
| Fax |
|
| Email |
sonam11dhiman@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushma Kumari Saini |
| Designation |
lecturer |
| Affiliation |
PGIMER |
| Address |
Roomno 211 Department of National Institute of Nursing Education PGIMER SEC-12 Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9888038248 |
| Fax |
|
| Email |
sushmadrsaini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sushma Kumari Saini |
| Designation |
lecturer |
| Affiliation |
PGIMER |
| Address |
Room no 211 Department of National Institute of Nursing Education PGIMER SEC-12 Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9888038248 |
| Fax |
|
| Email |
sushmadrsaini@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Nursing Education PGIMER SEC-12 Chandigarh |
|
|
Primary Sponsor
|
| Name |
National Institute of Nursing Education PGIMER SEC Chandigarh |
| Address |
National Institute of Nursing Education PGIMER SEC-12 Chandigarh PIN 160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| sonam dhiman |
Postgraduate Institute of Medical Education and Research Chandigarh |
OPD Department of Ophthalmology Advanced Eye Centre
Chandigarh
CHANDIGARH |
8178686448
sonam11dhiman@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee PGIMER Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H475||Disorders of other visual pathways, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nurse led counselling Intervention |
Nurse Led Counselling sessions will be held for the parents of children having cerebral visual impairment to improve adherence to the activities and exercises advised by doctor. This will be in addition to routine care they are given in the institute |
| Comparator Agent |
Routine Care practices |
Exercises and activities which are recommended by doctor for children with cerebral visual impairment |
|
Inclusion Criteria
Modification(s)
|
| Age From |
3.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children with CVI between the age of 3 month-12 years registered since 2018 onwards in AEC OPD at PGIMER, Chandigarh after August 2020 onwards. |
|
| ExclusionCriteria |
| Details |
Children with other Congenital anomalies along with CVI, who require immediate medical care. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Adherence to regular eye activities |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Vision and Quality of Life of children living with Cerebral Visual Impairment |
4 Weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
16/07/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
In this research study a Nurse Led Counselling Intervention will be given to parents of children with cerebral visual impairment (CVI) telephonically for adherence to regular eye activities which will enhance adherence and the visual function as well as quality of life children with CVI. This Nurse Led Counselling Intervention will include information regarding CVI and various eye activities which will be performed by parents during day hours for their children. Adherence to these activities will improve the visual functioning of children with CVI in long run. |