| CTRI Number |
CTRI/2019/06/019641 [Registered on: 12/06/2019] Trial Registered Prospectively |
| Last Modified On: |
10/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess the effectiveness of Nurse led counselling programme on the adherence of eye patch application among patient of Amblyopia |
|
Scientific Title of Study
|
An interventional study to assess the effectiveness of Nurse led Counselling programme on the adherence of eye patch application for improvement in vision and alignment of the eye among children with Amblyopia attending AEC at PGIMER chandigarh 2018-20 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivani |
| Designation |
Student |
| Affiliation |
NINE PGIMER Chandigarh |
| Address |
Sec 12 NINE PGIMER Chandigarh 160012
Sec 12 NINE PGIMER Chandigarh 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7018368224 |
| Fax |
|
| Email |
shivanijamwal1994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushma Saini |
| Designation |
Lecturer |
| Affiliation |
NINE, PGIMER, Chandigarh |
| Address |
Sec 12 NINE PGIMER Chandigarh 160012
Sec 12 NINE PGIMER Chandigarh 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9888038248 |
| Fax |
|
| Email |
sushmadrsaini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shivani |
| Designation |
Student |
| Affiliation |
NINE PGIMER Chandigarh |
| Address |
Sec 12 NINE PGIMER Chandigarh 160012
Sec 12 NINE PGIMER Chandigarh 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7018368224 |
| Fax |
|
| Email |
shivanijamwal1994@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Nursing Education PGIMER Chandigarh |
|
|
Primary Sponsor
|
| Name |
PGIMER Chandigarh |
| Address |
sector 12 NINE, PGIMER, Chandigarg 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 |
| Shivani |
PGIMER Chandigarh |
Eye OPD at Advance eye centre of PGIMER Chandigarh
Chandigarh
CHANDIGARH |
7018368224
shivanijamwal1994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of PGIMER, Chandigarh e |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H518||Other specified disorders of binocular movement, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No intervention |
No intervention |
| Intervention |
nurse led counselling programme on the adherence of eye patch application |
interview schedule is prepare for checking the adherence demonstration will be given to the parents and their children on eye patch application, telephonic follow ups and OPD will be done to maintain the adherence |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children with Amblyopia at the age of 3-12 Years attending Eye OPD at PGIMER, Chandigarh during the period of July2019- August 2019. |
|
| ExclusionCriteria |
| Details |
Children whose telephonically follow up is not possible |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Adherence to eye Patch Application
Improvement of vision in affected eye
Improvement of alignment in affected eye
|
3 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| behaviour modification related to importance of eye patch application |
3 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
28/06/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/06/2019 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Research article will be published in good journal |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
An interventional study will be conducted on effectiveness of Nurse led counselling programme on the adherence of eye patch application for the improvement of vision and misalignment of the eye. This is an randomised control trial in which two groups are taken and randomised by computer generated table. the group are randomised into control and experimental group. counselling provided to the interventional group and normal routine care is provide to the control group. after completing of my study same intervention will be provided to the control group also |