A Test of the Effectiveness of a Device and Distraction for Pediatric Immunization Pain
|Procedural Pain||Device: Device: Buzzy Device: Buzzy: sham device||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Phase II Study of the Effectiveness of a Device and Distraction for Pediatric Immunization Pain in Multiple Age Groups|
- Pain of immunization [ Time Frame: 5 minutes during or immediately after immunizations ]Infants' and toddlers' pain is assessed by coding videotapes using the FLACC (face, legs, activity, crying and consolability) scale. Patients age 4 and older rate pain using self-report via the Faces Pain Scale Revised.
- Pain from immunization using observational measures [ Time Frame: 5 minutes immediately following immunization ]Caretakers and nurses administering the shots rate pain using a 10cm Visual analog scale from "no pain" to "most pain possible"; duration of infant cry is also assessed following the procedure using coded videotape recordings.
- Treatment satisfaction [ Time Frame: 5 minutes after immunizations ]10 item scale ranging from "strongly agree" to "strongly disagree" with ten parameters of satisfaction with the methods and concepts of immunization.
|Study Start Date:||April 2010|
|Study Completion Date:||April 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
No Intervention: Standard Care
Immunizations are given with standard care of no pain control
Active Comparator: Experimental
Vibrating device with cold pack held to arm proximal to injections within the same dermatome; caretakers offered and instructed in use of distraction cards.
Device: Device: Buzzy
"Buzzy", the vibrating cold pack, is held in place with a velcro strap or pressed by caretaker or nurse immediately prior and during immunizations. The vibration is activated and the device remains in place during the shot, moving locations if multiple shots are given. Distraction cards with pictures on one side and questions on the other are shown to the child while the caretaker asks the finding and seeking questions on the back.
Sham Comparator: Sham Device
The device without batteries or cold pack held to arm proximal to injections. No formal distraction.
Device: Buzzy: sham device
The identical device without batteries or a cold pack is held in place proximal to the site with a velcro strap or pressed by parent or nurse immediately prior to immunizations. The device remains in place throughout the procedure, moving locations to complete multiple shots.
Other Name: Buzzy
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 is no pain relief. An inexpensive, immediately effective form of needle pain control could reduce needle phobia or vaccine refusal in the long term if demonstrated to be effective for immunization pain.
Distraction can decrease procedural distress in children by 50%. The effect of using a multi-modal pain and distraction relieving approach has not been rigorously studied.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01152489
|Principal Investigator:||Amy Baxter, MD||MMJ Labs LLC|