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临床试验/NCT07002372
NCT07002372招募中不适用

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

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2025年5月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
182
试验地点
1
主要终点
Rate and area of subconjunctival hemorrhage

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Procedural video viewing Group

Experimental

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

干预措施: Procedure video viewing (Behavioral)

Control Group

No Intervention

Participants will not view the video before the treatment.

结局指标

主要结局

Rate and area of subconjunctival hemorrhage

时间窗: 3 minutes after the intravitreal injection procedure.

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.

次要结局

  • Anxiety levels assessed by State-Trait Anxiety Inventory-State (STAI-S)(30 minutes before and after the procedure.)

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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