Phase II Study of the Effectiveness of a Device and Distraction for Pediatric Immunization Pain in Multiple Age Groups
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- MMJ Labs LLC
- Enrollment
- 345
- Primary Endpoint
- Pain of immunization
Study Overview
Brief Summary
The hypothesis of this study is that distraction cards used by the caretaker along with a vibrating cold pack placed proximal to the site of immunization will decrease the pain of routine pediatric immunizations when compared to a placebo device or standard care.
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 4 Months to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •children receiving routine immunizations
Exclusion Criteria
- •no caregiver present
- •chronic illness requiring frequent injections
- •clear cognitive impairments affecting communication
Arms & Interventions
Standard Care
Immunizations are given with standard care of no pain control
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.
Intervention: Device: Buzzy (Device)
Sham Device
The device without batteries or cold pack held to arm proximal to injections. No formal distraction.
Intervention: Buzzy: sham device (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Pain from immunization using observational measures(5 minutes immediately following immunization)
- Treatment satisfaction(5 minutes after immunizations)