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临床试验/NCT02035722
NCT02035722已完成2 期

A Visual Approach to Reducing Anxiety and Improving Knowledge Transfer for Patients Receiving Intravitreal Injections

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2011年9月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
73
试验地点
1
主要终点
Anxiety

研究概览

简要总结

Intravitreal injection of Ranibizumab (Lucentis, Genentech) is clinically indicated for patients with wet age-related macular degeneration (AMD) An disadvantage of this technique is the anxiety and discomfort which patients often experience due to the idea of "getting a needle in the eye". In addition, a recent case study indicated the importance of patient education in achieving positive outcomes from intravitreal injections of anti-vascular endothelial growth factor (VEGF) agents. The purpose of our study is to determine whether visual education on AMD and intravitreal injection can reduce patients' anxiety prior to the treatment, and lessen the impact of socioeconomical status on their understanding of the treatment and prognosis.

详细描述

The use of intravitreal injections of Ranibizumab (Lucentis, Genentech) is becoming increasing common for the management of age-related macular degeneration (AMD). It is therefore important to acknowledge and address patients' anxiety due to anticipated discomfort from the idea of "getting a needle in the eye". In addition, visual provision of information at diagnosis concerning long-term treatment expectation may enhance the informed consent process. The use of visual aids may also accommodate patients of different educational background when presented with new and complex treatment information. The purpose of our study is to determine whether visual education on AMD and intravitreal injection can reduce patients' anxiety prior to the treatment, and lessen the impact of socioeconomical status on their understanding of the treatment and prognosis. Although this tool will be developed in the context of injection-requiring retinal diseases, it has applications in the care of disease requiring long-term treatments.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (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

  • •18 years and older
  • •AMD patients requiring intravitreal injections

排除标准

  • •Unable to read or comprehend English
  • •Any contraindications to intravitreal injections, such as IOP elevations

研究组 & 干预措施

Control group

No Intervention

AMD-related information is not given to patients randomized to the control group.

Video materials

Active Comparator

Educational materials are presented in through a video (audio and visual)

干预措施: Video (Behavioral)

Print materials

Active Comparator

Educational materials are presented in the format of printed brochure (visual)

干预措施: Printed materials (Behavioral)

结局指标

主要结局

Anxiety

时间窗: Cross-sectional study, where questionnaires will be completed on the same day of clinic visit.

次要结局

  • Knowledge of AMD(Cross-sectional study, where questionnaires will be completed on the same day of clinic visit.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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