Status:
COMPLETED
A Test of the Effectiveness of a Device and Distraction for Pediatric Immunization Pain
Lead Sponsor:
MMJ Labs LLC
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Procedural Pain
Eligibility:
All Genders
4-12 years
Phase:
PHASE2
PHASE3
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 im...
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 in...
Eligibility Criteria
Inclusion
- children receiving routine immunizations
Exclusion
- no caregiver present
- chronic illness requiring frequent injections
- clear cognitive impairments affecting communication
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2011
Estimated Enrollment :
345 Patients enrolled
Trial Details
Trial ID
NCT01152489
Start Date
April 1 2010
End Date
April 1 2011
Last Update
June 22 2011
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