Intravitreal Injections-related Anxiety

Sponsor
University Health Network, Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT02035722
Collaborator
(none)
73
1
3
33
2.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Printed materials
  • Behavioral: Video
Phase 2/Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
73 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Visual Approach to Reducing Anxiety and Improving Knowledge Transfer for Patients Receiving Intravitreal Injections
Study Start Date :
Sep 1, 2011
Actual Primary Completion Date :
Apr 1, 2014
Actual Study Completion Date :
Jun 1, 2014

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control group

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

Active Comparator: Video materials

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

Behavioral: Video
AMD-related information is presented as in the form of a video

Active Comparator: Print materials

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

Behavioral: Printed materials
AMD-related information is presented to patients in the form of a brochure (i.e. printed materials)

Outcome Measures

Primary Outcome Measures

  1. Anxiety [Cross-sectional study, where questionnaires will be completed on the same day of clinic visit.]

Secondary Outcome Measures

  1. Knowledge of AMD [Cross-sectional study, where questionnaires will be completed on the same day of clinic visit.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Toronto Western Hospital Toronto Ontario Canada M5T 2S8

Sponsors and Collaborators

  • University Health Network, Toronto

Investigators

  • Principal Investigator: Wai-Ching Lam, University Health Network, Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT02035722
Other Study ID Numbers:
  • UHN-110463AE
First Posted:
Jan 14, 2014
Last Update Posted:
Feb 24, 2015
Last Verified:
Feb 1, 2015
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 24, 2015