Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001310358
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
16/10/2026
Date registered
Help: Date registered
30/10/2026
Date last updated
Help: Date last updated
30/10/2026
Date data sharing statement initially provided
Help: Data sharing statement date
30/10/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Pre-procedure Video Education on Patient Experience During Intravitreal Injections: A Randomised Controlled Trial
Scientific title
In adults undergoing intravitreal injections, does pre-procedure video education compared with standard clinician consent and counselling improve patient experience?
Additional trial identifiers [1] 318678 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Age-related macular degeneration 343890 0
Diabetic macular oedema 344018 0
Retinal vein occlusion 344019 0
Condition category
Condition code
Eye 340034 340034 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Participants allocated to the intervention group will receive pre-procedure video education about intravitreal injections. The approximately 3-minute animated educational video, developed by the research team, will be viewed individually on a laptop using headphones in the Ophthalmology Clinic waiting room prior to the intravitreal injection procedure. The educational video explains the injection process, potential risks and benefits and aftercare. The intervention will be administered once per participant at a single study visit. The research team will document each participant’s allocated study group at the study visit.
Intervention code [1] 335569 0
Treatment: Other
Description of the comparator or control
Participants allocated to the control group will have received standard clinician consent and counselling for intravitreal injections in accordance with routine clinical practice, without viewing the animated educational video. Consent and counselling will be provided by the treating clinician as part of routine clinical care. The comparator will be delivered individually, face-to-face, in the Ophthalmology Clinic. Participants will be included at a single study visit. The research team will document each participant’s allocated study group at the study visit.
Control group
Active

Outcomes
Primary outcome [1] 347186 0
Anxiety
Timepoint [1] 347186 0
Immediately following intravitreal injection.
Primary outcome [2] 347187 0
Satisfaction
Timepoint [2] 347187 0
Immediately following intravitreal injection.
Primary outcome [3] 347188 0
Pain
Timepoint [3] 347188 0
Immediately following intravitreal injection.
Secondary outcome [1] 469404 0
Participant-reported sufficiency of information about what to expect during intravitreal injections.
Timepoint [1] 469404 0
Immediately following intravitreal injection.
Secondary outcome [2] 469405 0
Intervention-group participants’ willingness to recommend the educational video to other patients receiving intravitreal injections.
Timepoint [2] 469405 0
Immediately following intravitreal injection.

Eligibility
Key inclusion criteria
Adults aged 18 years or older requiring an intravitreal injection at the Royal Adelaide Hospital Ophthalmology Clinic.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Unable to consent, not fluent in English or have cognitive impairment or mental disability.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated to either the intervention group or the control group using computer-generated permuted block randomisation, with a 1:1 allocation ratio.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A total sample size of 126 participants (63 per group) is required to detect a clinically meaningful between-group difference of 10 points in mean numeric rating scale (NRS) anxiety score, assuming a standard deviation of 20 points, a two-sided significance level of 0.05 and 80% power. The target recruitment has been increased to 134 participants (67 per group) to allow for potential participant withdrawal and incomplete data.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
28/08/2026
Date of last participant enrolment
Anticipated
30/11/2026
Actual
Date of last data collection
Anticipated
30/11/2026
Actual
Sample size
Target
134
Accrual to date
85
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 30361 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 46776 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 323247 0
Hospital
Name [1] 323247 0
Royal Adelaide Hospital
Country [1] 323247 0
Australia
Primary sponsor type
Government body
Name
Central Adelaide Local Health Network
Address
Country
Australia
Secondary sponsor category [1] 326215 0
None
Name [1] 326215 0
Address [1] 326215 0
Country [1] 326215 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321643 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 321643 0
Ethics committee country [1] 321643 0
Australia
Date submitted for ethics approval [1] 321643 0
23/01/2026
Approval date [1] 321643 0
13/05/2026
Ethics approval number [1] 321643 0
22526

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 154374 0
Prof Robert Casson
Address 154374 0
Royal Adelaide Hospital, Port Rd, Adelaide, 5000, South Australia
Country 154374 0
Australia
Phone 154374 0
+61 418 857 813
Fax 154374 0
Email 154374 0
[email protected]
Contact person for public queries
Name 154375 0
Layla Bunjo
Address 154375 0
Royal Adelaide Hospital, Port Rd, Adelaide, 5000, South Australia
Country 154375 0
Australia
Phone 154375 0
+61 8 7074 0000
Fax 154375 0
Email 154375 0
[email protected]
Contact person for scientific queries
Name 154376 0
Robert Casson
Address 154376 0
Royal Adelaide Hospital, Port Rd, Adelaide, 5000, South Australia
Country 154376 0
Australia
Phone 154376 0
+61 8 7074 0000
Fax 154376 0
Email 154376 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.