| CTRI Number |
CTRI/2025/10/096592 [Registered on: 29/10/2025] Trial Registered Prospectively |
| Last Modified On: |
28/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [one group Pretest Post test only Design] |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of an Integrated Eye Care Training Program on Nursing Students Competences |
|
Scientific Title of Study
|
Effectiveness of Integrated Eye Care Training program on Competences of Undergraduate Nursing Students in a Selected College at Mangaluru |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
USMAN ABUBAKAR |
| Designation |
Registered nurse,Registered ophthalmic nurse(BSc,ROPHN) |
| Affiliation |
Yenepoya Nursing College |
| Address |
Yenepoya Nursing College ,Naringana,Mangaluru, Department of Community Health Nursing.4th Floor,2nd Year M.sc Class(Room v)
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9482045001 |
| Fax |
|
| Email |
abubakaru889@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
USMAN ABUBAKAR |
| Designation |
Registered nurse,Registered ophthalmic nurse(BSc,ROPHN) |
| Affiliation |
Yenepoya Nursing College |
| Address |
Institution Name: Yenepoya (Deemed to be University) - College of Nursing
Street Address / Location: Department of Community Health Nursing, Room V, 4th Floor, Yenepoya Nursing College, Naringana, Deralakatte
City: Mangaluru
State: Karnataka
Pincode: 575018
Country: India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9482045001 |
| Fax |
|
| Email |
abubakaru889@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs.Savitha Naik |
| Designation |
Assistant professor and Coordinator |
| Affiliation |
Yenepoya Nursing College |
| Address |
• Department of Community Health Nursing,Yenepoya Nursing College
• Affiliation: Department of Community Health Nursing, Yenepoya Nursing College, Yenepoya (Deemed to be University)
• Address: Department of Community Health Nursing, Room II, 4th Floor, Yenepoya Nursing College, Naringana, Deralakatte, Mangaluru, Karnataka, 575018, India
•Email: savithanaik@yenepoya.edu.in
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8884033986 |
| Fax |
|
| Email |
abubakaru889@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yenepoya Nursing College
University Road, Deralakatte
Mangaluru, Karnataka
575018 |
|
|
Primary Sponsor
|
| Name |
Principla InvestigatorUsman Abubakar |
| Address |
Yenepoya Nursing College
University Road, Deralakatte
Mangalore, Karnataka 575018
India |
| Type of Sponsor |
Research institution |
|
|
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 USMAN ABUBAKAR |
Yenepoya Nursing College?Institution |
Yenepoya University,,Department of community Health Nursing,Room NumberI,UniversitY Road, Deralakatte,Mangalore - 575018,Karnataka.
Dakshina Kannada
KARNATAKA |
09482045001
08242204667
39849@yenepoya.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee-3 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Lack of formal training in eye care for nursing students |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
integrated Eye Care training program. |
1. Pretest and Training Session:
Participants will first be briefed about the study objectives, procedures, potential risks, and benefits.
Adequate time (approximately 15–20 minutes) will be given to each participant to read the information sheet, ask questions, and clarify any doubts before signing the consent form.
Privacy will be strictly maintained during the consent process to allow participants to make an informed and voluntary decision.
2. Posttest Session:
Conducted one week after the training session, with a brief reminder about the study. No new consent is required unless protocol changes occur.
Following consent, participants will undergo a pretest (20 minutes) attend a training session (45 minutes) and complete a posttest after one week
Participation is entirely voluntary, and participants may withdraw at any stage without any consequences. All data collected will be kept confidential and used solely for research purposes.
|
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Both |
| Details |
Only 4th-year B. Sc nursing students of Yenepoya Nursing College.1. Pretest and Training Session:
Participants will first be briefed about the study objectives, procedures, potential risks, and benefits.
Adequate time (approximately 15–20 minutes) will be given to each participant to read the information sheet, ask questions, and clarify any doubts before signing the consent form.
Privacy will be strictly maintained during the consent process to allow participants to make an informed and voluntary decision.
2. Posttest Session:
Conducted one week after the training session, with a brief reminder about the study. No new consent is required unless protocol changes occur.
Following consent, participants will undergo a pretest (20 minutes) attend a training session (45 minutes) and complete a posttest after one week
Participation is entirely voluntary, and participants may withdraw at any stage without any consequences. All data collected will be kept confidential and used solely for research purposes.
|
|
| ExclusionCriteria |
| Details |
4th-year B Sc nursing students who have already received formal training in eye care
Students with medical conditions, health-related issues that prevent them from fully participating in the training sessions or assessments.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in knowledge score on integrated eye care, measured by a validated questionnaire. |
Mean change in knowledge score on integrated eye care, measured by a validated questionnaire.With one week interval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in skill competency score for an eye care procedure (e.g., eye irrigation or assessment), measured by an Objective Structured Clinical Examination OBJECTIVE STRUCTURED PRACTICAL EXAMINATION (OPCE) checklist |
Baseline: Before the training module.
Post-Intervention: Immediately after the training module.One week interval |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
30/11/2025 |
| 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="14" |
|
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Through the permission of the research teams email Id
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study will evaluate the effectiveness of a structured integrated eye care training program on improving the competences of undergraduate nursing students. The research will be conducted at a selected nursing college in Mangaluru. A pre-test and post-test design will be used to measure changes in student competences. A group of nursing students will receive the specialized eye care training. Their knowledge and practical skills will be assessed before and after the training program using standardized assessment tools. The primary goal is to determine if this integrated training program can significantly improve the eye care competences of nursing students. |