Effect of Including Synera® in Discussions on Dialysis Access Conversion in Patients With Needle Phobias
Stopped early · Phase 4
Conditions studied: Needle Phobia, Phobic Disorders
In brief
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.
Key facts
- Study ID
- NCT01623583
- Run by
- Davita Clinical Research
- People needed
- 10
- Starts
- 2014-04-01
- Expected to finish
- 2015-03-01
- Last updated by the study team
- 2016-08-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patient receiving hemodialysis at a DaVita clinic/dialysis center
- Receiving in-center hemodialysis thrice weekly
- Central venous catheter (CVC) use for > 180 days
- Patients report a fear of needles as a top-3-reason for failure to get an arteriovenous fistula/graft
You may not qualify if…
- Patients have a known intolerance or hypersensitivity to Synera
- Patient with a history of or past diagnosis of severe hepatic disease
- Patient is currently receiving any class 1 antiarrhythmic drugs (i.e., tocainide, mexiletine, etc)
- Patient has a clinically significant illness within 14 days of Screening/Day 1 that, in the opinion of the investigator, would preclude the subject from participating in the study
- Patient has an AVF or AVG in place or is scheduled for placement
- Women and men whose partners are of childbearing potential (defined as premenopausal and not surgically sterilized [ie, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy] or postmenopausal for < 2 years) agree to practice 1 of the following medically acceptable methods of birth control and agree to continue with the regimen throughout the duration of the study: Oral, implantable, or injectable contraceptives for 3 consecutive months before the Screening Visit; Intrauterine device (IUD); and double barrier method (ie, condom, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream)
- Patient has significant disease or condition that, in the PI's opinion, may interfere with protocol adherence or subjects' ability to provide informed consent
- Patient is unable to read or comprehend English at a 6th grade level
- Patient has a visual impairment and is unable to read the survey instruments
- Patient has a suspected or known access-related infection at the time of enrollment
Where it is running
- Sunset Dialysis Center — Rancho Cordova, California, United States
- Natomas Dialysis — Sacramento, California, United States
- Asheville Kidney Center — Asheville, North Carolina, United States
Full record on ClinicalTrials.gov
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