A Test of the Effectiveness of a Device and Distraction for Pediatric Immunization Pain

Phase 2

Completed

• Conditions: Procedural Pain

• Registration Number: NCT01152489
• Lead Sponsor: MMJ Labs LLC

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 Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-06-26
• Study First Submitted QC: 2010-06-26
• Study First Posted: 2010-06-29
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-21
• Last Update Posted: 2011-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 345

Inclusion Criteria

• children receiving routine immunizations

Exclusion Criteria

• no caregiver present
• chronic illness requiring frequent injections
• clear cognitive impairments affecting communication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain of immunization	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 Outcome Measures

Name	Time	Method
Pain from immunization using observational measures	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	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.