Effect of Including Synera® in Discussions on Dialysis Access Conversion in Patients With Needle Phobias

Summary

An arteriovenous fistula or graft access (AVF/AVG) for dialysis is often considered a superior option for delivery of dialysis, but requires needles to be inserted. Patients on dialysis who indicate fear of needles as the reason for not switching from a long-term central venous catheter (CVC) access to a fistula or graft access and who otherwise meet the eligibility criterial will be asked to participate. Patients will receive either a standard or an enhanced intervention to address their fear of needles. The enhanced intervention includes the standard intervention plus video training about Synera and trying out an actual patch. Over the 4 months following the intervention, how many patients sign up to switch access will be tracked.

Conditions

• Needle Phobia
• Phobic Disorders

Interventions

OTHER

Enhanced Needle Phobia Intervention

The enhanced intervention will include the standard intervention, with two enhancements: * The video will include a segment with a patient using and discussing the analgesic effects of the Synera patch * Before the intervention, a nurse will explain how Synera works and demonstrate its efficacy by having the patient apply it to the non-dominant forearm and leave it in place for 30 minutes, during the intervention. The patient will then be given the opportunity to gently poke 3 times an area of the forearm at least 3 inches from where the patch was applied, and then poke 3 times the center of the area where the patch was applied. The patient may repeat this process up to 3 times. The patient will be asked if he or she can feel the difference in sensitivity.

OTHER

Standard Needle Phobia Intervention

The standard intervention will include the following components: 1. Educational material and discussion with the social worker about the benefits of AVF/AVG over catheter. 2. Basic training on relaxation breathing 3. Brief video of a patient overcoming needle phobia 4. Exposure to a cannulation needle while practicing relaxation breathing, ending in the patients physically holding the needle

Sponsors & Collaborators

• Nuvo Research Inc.

  collaborator INDUSTRY

• Davita Clinical Research

  lead INDUSTRY

Principal Investigators

• Mahesh Krishnan, MD, MPH, MBA · Davita Clinical Research

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-04-30

Primary Completion

2015-03-31

Completion

2015-03-31

Countries

• United States

Study Locations