A Phase 2/3 interventional study of Device: Buzzy and Buzzy: sham device in Procedural Pain, sponsored by MMJ Labs LLC. Completed. Open to participants aged 4 Months to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-06-22.
Sponsored by MMJ Labs LLC · Phase 2/3, Interventional, and Supportive care
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.
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.
241 studies on the registry are indexed under Pain, Procedural; 64 are open to participants now.
This study's planned enrollment of 345 is above the median of 90 across 227 interventional studies indexed under Pain, Procedural.
Browse Pain, Procedural studies →MMJ Labs LLC is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Immunizations are given with standard care of no pain control
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
The device without batteries or cold pack held to arm proximal to injections. No formal distraction.
Device: Buzzy: sham device
"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.
Also known as: Buzzy(R), Flippits(TM)
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.
Also known as: Buzzy
Pain of immunization
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.
Time frame: 5 minutes during or immediately after immunizations
Pain from immunization using observational measures
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.
Time frame: 5 minutes immediately following immunization
Treatment satisfaction
10 item scale ranging from "strongly agree" to "strongly disagree" with ten parameters of satisfaction with the methods and concepts of immunization.
Time frame: 5 minutes after immunizations
No study locations are listed for this record.
The record gives a start of Apr 2010, a primary completion of Apr 2011 and a completion of Apr 2011. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.
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