Buzzy: An Integration of Vibration, Cold, and Distraction for Pediatric Needle Pain Relief
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Pain
- Sponsor
- Georgia State University
- Enrollment
- 81
- Locations
- 1
- Primary Endpoint
- Faces Pain Scale-Revised (FPS-R)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
A vibrating cold pack placed proximal to the site of venipuncture will decrease the pain of cannulation when compared to vapocoolant spray.
Detailed Description
Needle pain is the most common and the most feared source of childhood pain, resulting in needle phobia for 10% of adults. Current pain relief options include numbing creams, vapocoolant spray, or injected lidocaine. 17 million pediatric IV access procedures are done yearly with no pain intervention. An inexpensive, immediately acting form of needle pain control could reduce needle phobia in the long term if demonstrated to be effective for needle pain. This study will evaluate pain self report and parent report using the Faces Pain Scale revised, and video-coded OSBD-R scores for patients undergoing emergency department venous access or cannulation procedures. Demographic information, pre-procedural anxiety, and success data from the attempts at placement will be included.
Investigators
Lindsey L Cohen, PhD
Principal Investigator
Georgia State University
Eligibility Criteria
Inclusion Criteria
- •Patients requiring venipuncture in a pediatric emergency department
- •Informed consent
- •Patient assent
- •Exclusion criteria:
- •Patients with sickle cell or other sensitivity to cold
- •Nerve damage in the area
- •Abrasion or break in skin where device would be placed
- •Critically ill
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Faces Pain Scale-Revised (FPS-R)
Time Frame: 5 minute
Self-report measure of pain via 6 faces ranging from neutral to increasing pain expression. The scoring for the scale ranges from 0-10 with lower scores representing lower pain and higher scores representing higher pain. The FPS-R was conducted several minutes following venipuncture. This time was not tracked, but it was typically between 2-5 minutes following completion of the venipuncture.
Secondary Outcomes
- Number of Participants With Venipuncture Success in One Attempt(5 minutes)
- OSBD-R Observational Pain/Distress Scale(5 minute)