Effect of Video Viewing on Intravitreal Injection Experience

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

Study Objective The goal of this clinical trial is to evaluate whether viewing a procedural video can improve the patient experience and reduce the incidence and severity of subconjunctival hemorrhage in individuals undergoing intravitreal anti-VEGF injections.

Key Research Questions

1. Can viewing the procedural video prior to treatment reduce the rate and/or area of subconjunctival hemorrhage? 2. Can the video improve the patient experience, specifically by reducing anxiety levels and increasing satisfaction with the treatment process?

Study Design Participants will be randomly assigned to either an intervention group, who will watch an educational video explaining the injection procedure, or a control group, who will not view the video.

All participants will complete the State-Trait Anxiety Inventory-State (STAI-S) questionnaire both before and after treatment to assess changes in anxiety levels.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients who are receiving their first intravitreal injection of anti-VEGF medication due to retinal diseases

Mentally competent, and able to communicate without barriers

Willing to voluntarily sign an informed consent form.

Disqualifiers

History of previous eye surgery

Best-corrected visual acuity in the better eye worse than 0.3

The target eye is complicated with neovascular glaucoma.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Procedure video viewing

    Behavioral

    Patients who have never had an intravitreal injection before will be randomly assigned to watch an educational video about the procedure prior to treatment.

Treatment groups

182 Participants
are divided into 2 treatment groups
Group A: Procedural video viewing GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Rate and area of subconjunctival hemorrhage

After the injection, a photograph of the eye will be taken to document the presence of subconjunctival hemorrhage and to measure the hemorrhage area using ImageJ software.

Time frame
3 minutes after the intravitreal injection procedure.

Secondary outcomes

1

Anxiety levels assessed by State-Trait Anxiety Inventory-State (STAI-S)

State-Trait Anxiety Inventory-State (STAI-S) questionnaire both before and after treatment to assess changes in anxiety levels

Time frame
30 minutes before and after the procedure.

Other outcomes

1

Patient satisfaction assessed by a satisfaction score questionnaire

Patient satisfaction with the treatment process will be assessed using a 10-point Likert scale satisfaction score collected after the procedure, where 1 indicates "not satisfied at all" and 10 indicates "completely satisfied".

Time frame
30 minutes after the procedure.
2

Physician's assessment of patient cooperation during the procedure

Physician's assessment of patient cooperation during the procedure Patient cooperation will be assessed by the physician immediately after the procedure using a 10-point Likert scale, where 1 indicates completely uncooperative and 10 indicates fully cooperative. The scale is based on observable patient behavior such as adherence to instructions, physical movements, and verbal interaction during the procedure.

Time frame
Immediately after the intravitreal injection procedure
3

Total procedure time

The time duration from the start of disinfection to the completion of the injection.

Time frame
During the procedure.

Sponsors and contacts

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