NCT01152489

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

Phase II Study of the Effectiveness of a Device and Distraction for Pediatric Immunization Pain in Multiple Age Groups

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 345 (estimated)
• Sponsor: MMJ Labs LLC · Industry
• Sex: All
• Age: 4 Months – 12 Years
• Healthy volunteers: Accepted

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.

Conditions

• Procedural Pain

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2010-06-29
• Last updated: 2011-06-22