Effect of Video Viewing on Intravitreal Injection Experience

NCT ID: NCT07002372

Last Updated: 2025-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-05

Study Completion Date

2025-10-05

Brief Summary

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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.

Detailed Description

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Conditions

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Age Related Macular Degeneration Diabetic Retinopathy Choroidal Neovascularization Retinal Vein Occlusion Cystoid Macular Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Procedural video viewing Group

Participants will watch an educational video explaining the injection procedure prior to treatment.

Group Type EXPERIMENTAL

Procedure video viewing

Intervention Type 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.

Control Group

Participants will not view the video before the treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiaoyun Fang, MD., PhD

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

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Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaoyun Fang, MD., PhD.

Role: CONTACT

+ 86 13588411946

Fang Zheng, MD., PhD

Role: CONTACT

+86 18258499106

Facility Contacts

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Fang Zheng

Role: primary

18258499106

References

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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.

Reference Type BACKGROUND
PMID: 31305506 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28064517 (View on PubMed)

Other Identifiers

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2024-1393

Identifier Type: -

Identifier Source: org_study_id

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