A Test of the Effectiveness of a Device for Pediatric Immunization Pain (Buzzy)
|ClinicalTrials.gov Identifier: NCT00910611|
Recruitment Status : Unknown
Verified June 2010 by MMJ Labs LLC.
Recruitment status was: Active, not recruiting
First Posted : June 1, 2009
Last Update Posted : June 25, 2010
|Condition or disease||Intervention/treatment||Phase|
|Pain||Device: Buzzy||Not Applicable|
Needle pain is the most common and the most feared source of childhood pain, resulting in needle phobia for 10% of adults. Current standard of care for immunizations in the us provides analgesia 6% of the time. An inexpensive, immediately acting form of needle pain control could reduce needle phobia or vaccine refusal in the long term if demonstrated to be effective for immunization pain.
This study will evaluate pain responses using video-coded FLACC scores for patients undergoing routine pre-school immunizations. Parent and patient pain assessments, as well as demographic information and pre-procedural anxiety coded from videos will be included.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Relieving Pediatric Immunization Pain Using A Reusable Personal Device|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||June 2009|
|Estimated Study Completion Date :||July 2010|
No Intervention: Standard Care
Immunizations given with standard care of no pain control
Vibrating device with cold pack held to arm proximal to injections
"Buzzy", the vibrating cold pack, is pressed by parent or nurse immediately prior to immunizations. The vibration is activated and the device remains in place throughout the procedure, moving locations to complete the 4 shots.
Other Name: Buzzy R
- FLACC observational pain/distress scale [ Time Frame: 5 minutes ]Videotaped scores are generated from the 30 seconds before the immunization and during the first two and second two sets of shots. Scoring is complete when the final bandage is placed over the last immunization.
- Self report using Faces Pain Scale - Revised [ Time Frame: 1 minute after immunizations are complete ]After the first arm and second sets of two shots, children and parents are asked to indicate which face represents how much pain they (or the child) felt.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00910611
|United States, Georgia|
|Sandy Springs Pediatrics and Adolescent Medicine|
|Atlanta, Georgia, United States, 30342|
|Principal Investigator:||Amy L Baxter, MD||MMJ Labs LLC|