Intravitreal Injections-related Anxiety

Phase 2

Completed

• Conditions: Age-related Macular Degeneration
• Interventions: Behavioral: Video; Behavioral: Printed materials

• Registration Number: NCT02035722
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2014-01-10
• Study First Submitted QC: 2014-01-10
• Study First Posted: 2014-01-14
• Primary Completion: 2014-04
• Study Completion: 2014-06
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-20
• Last Update Posted: 2015-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

• 18 years and older
• AMD patients requiring intravitreal injections

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Video materials	Video	Educational materials are presented in through a video (audio and visual)
Print materials	Printed materials	Educational materials are presented in the format of printed brochure (visual)

Primary Outcome Measures

Name	Time	Method
Anxiety	Cross-sectional study, where questionnaires will be completed on the same day of clinic visit.

Secondary Outcome Measures

Name	Time	Method
Knowledge of AMD	Cross-sectional study, where questionnaires will be completed on the same day of clinic visit.

Trial Locations

Locations (1)

Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada