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Recruiting NCT07002372

Effect of Video Viewing on Intravitreal Injection Experience

No phase Interventional Age Related Macular Degeneration Diabetic Retinopathy Choroidal Neovascularization Retinal Vein Occlusion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Procedure video viewing.
Who it may be relevant to
Registry conditions: Age Related Macular Degeneration, Diabetic Retinopathy, Choroidal Neovascularization, Retinal Vein Occlusion. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Impact of Procedural Video Viewing on Patients Undergoing Intravitreal Anti-VEGF Injections

Overview

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.

Interventions

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

Primary outcome measures

  • Rate and area of subconjunctival hemorrhage [Time frame: 3 minutes after the intravitreal injection procedure.]
Secondary outcome measures (1)
  • Anxiety levels assessed by State-Trait Anxiety Inventory-State (STAI-S) [Time frame: 30 minutes before and after the procedure.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Other

Study locations

China · 1 center
  • Second Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou

Publications

  • Yahalomi T, Hecht I, Lagstein O, Nemet A, Pe'er L, Hadad F, Keren-Yaar A, Kassem R, Burgansky-Eliash Z, Bar A, Achiron A. REDUCTION OF POSTINTRAVITREAL INJECTION PAIN USING ICE: An Open-Label Interventional Randomized Controlled Trial. Retina. 2020 Jul;40(7):1434-1438. doi: 10.1097/IAE.0000000000002608. PMID 31305506
  • Boyle J, Vukicevic M, Koklanis K, Itsiopoulos C, Rees G. Experiences of patients undergoing repeated intravitreal anti-vascular endothelial growth factor injections for neovascular age-related macular degeneration. Psychol Health Med. 2018 Feb;23(2):127-140. doi: 10.1080/13548506.2016.1274040. Epub 2017 Jan 9. PMID 28064517

Identifiers

NCT: NCT07002372 · 2024-1393

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗