| CTRI Number |
CTRI/2024/03/064493 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of additional audiovisual aided consent on knowledge and anxiety levels among cataract surgery patients |
|
Scientific Title of Study
|
Effect of audiovisual aided informed consent on knowledge and anxiety levels among patients undergoing elective
cataract surgery – A Randomised control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nirupama Varadhan |
| Designation |
Post Graduate |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Room no.118, First floor, Department of Ophthalmology,
Mahatma Gandhi Medical College and Research Institute
Pondicherry Cuddalore EC Road,
Pillaiyarkuppam, Puducherry 607402.
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9361741177 |
| Fax |
|
| Email |
nirupamavaradhan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Swathi Nagarajan |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Department of Ophthalmology
Mahatma Gandhi Medical College and Research Institute
Pondicherry Cuddalore EC Road,
Pillaiyarkuppam, Puducherry 607402.
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9488540930 |
| Fax |
04132616700 |
| Email |
swathin@mgmcri.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Nirupama Varadhan |
| Designation |
Post Graduate |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Room no.118, First floor,Department of Ophthalmology,
Mahatma Gandhi Medical College and Research Institute
Pondicherry Cuddalore EC Road,
Pillaiyarkuppam, Puducherry 607402.
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9361741177 |
| Fax |
|
| Email |
nirupamavaradhan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Medical College and Research Institute,
Pondicherry Cuddalore EC Road, Pillaiyarkuppam, Puducherry 607402. |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Room.118, First floor, Mahatma Gandhi Medical College and Research Institute, Pondicherry- Cuddalore Road,ECR,Pillaiyarkuppam, Puducherry, 607402 |
| Type of Sponsor |
Private medical college |
|
|
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 Nirupama Varadhan |
Mahatma Gandhi Medical College and Research Institute |
Room no.118, First floor, Department of ophthalmology,
Mahatma Gandhi Medical College and Research Institute
Pondicherry Cuddalore EC Road,
Pillaiyarkuppam, Puducherry 607402.
Pondicherry
PONDICHERRY |
9361741177
nirupamavaradhan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee (Mahatma Gandhi Medical College and Research Institute) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H250||Age-related incipient cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Audiovisual aided informed consent |
Knowledge and anxiety levels assessed in patients undergoing elective cataract surgery using Audiovisual aided consent over a period of one year |
| Comparator Agent |
Routine verbal consent |
Knowledge and anxiety levels assessed in patients undergoing elective cataract surgery using routine verbal consent over a period of one year |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
Patients planned for their first eye elective cataract surgery |
|
| ExclusionCriteria |
| Details |
Patients who are hard of hearing
Patients with poor comprehension
Patients who cannot give legal consent
Patients with visual acquity of less than 3/60 in the better eye |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparing knowledge and anxiety levels among patients undergoing elective cataract surgery using tradional informed consent process and audiovisual aided informed consent |
Before administering consent and 24 hours after administering consent |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="584"
Sample Size from India="584"
Final Enrollment numbers achieved (Total)= "610"
Final Enrollment numbers achieved (India)="610" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/04/2024 |
| Date of Study Completion (India) |
30/04/2024 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Manuscript under preparation |
|
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 - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- 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 - Proposals should be directed to [nirupamavaradhan@gmail.com].
- For how long will this data be available start date provided 19-10-2025 and end date provided 18-10-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
There are not many studies done on the effect of audiovisual aids on informed consent process for cataract surgery in a rural population in India. The use of a video for informed consent process is also not much in use. If the use of video in informed consent for cataract surgery is found to be effective, it will help in making the informed consent procedure more uniform. |