A Test of the Effectiveness of a Device for Pediatric Immunization Pain (Buzzy)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by MMJ Labs LLC.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
MMJ Labs LLC
ClinicalTrials.gov Identifier:
NCT00910611
First received: March 13, 2009
Last updated: June 24, 2010
Last verified: June 2010

March 13, 2009
June 24, 2010
January 2009
June 2009   (final data collection date for primary outcome measure)
FLACC observational pain/distress scale [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
Videotaped scores are generated from the 30 seconds before the immunization and during the first two and second two sets of shots. Scoring is complete when the final bandage is placed over the last immunization.
FLACC observational pain/distress scale [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00910611 on ClinicalTrials.gov Archive Site
Self report using Faces Pain Scale - Revised [ Time Frame: 1 minute after immunizations are complete ] [ Designated as safety issue: No ]
After the first arm and second sets of two shots, children and parents are asked to indicate which face represents how much pain they (or the child) felt.
Self report using Faces Pain Scale - Revised [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Test of the Effectiveness of a Device for Pediatric Immunization Pain
Relieving Pediatric Immunization Pain Using A Reusable Personal Device

A vibrating cold pack placed proximal to the site of immunization will decrease the pain of routine preschool immunizations when compared to 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 provides analgesia 6% of the time. An inexpensive, immediately acting form of needle pain control could reduce needle phobia or vaccine refusal in the long term if demonstrated to be effective for immunization pain.

This study will evaluate pain responses using video-coded FLACC scores for patients undergoing routine pre-school immunizations. Parent and patient pain assessments, as well as demographic information and pre-procedural anxiety coded from videos will be included.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Pain
Device: Buzzy
"Buzzy", the vibrating cold pack, is pressed by parent or nurse immediately prior to immunizations. The vibration is activated and the device remains in place throughout the procedure, moving locations to complete the 4 shots.
Other Name: Buzzy R
  • No Intervention: Standard Care
    Immunizations given with standard care of no pain control
  • Experimental: Buzzy
    Vibrating device with cold pack held to arm proximal to injections
    Intervention: Device: Buzzy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
July 2010
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients receiving standard preschool immunizations
  • Informed consent

Exclusion Criteria:

  • Clear cognitive impairments affecting communication
  • Chronic illness requiring frequent injections
  • Patients with sickle cell or other sensitivity to cold
  • Patients who have received more than two immunizations on the same visit within the past two years.
Both
4 Years to 6 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00910611
08-028, 1R44HD056647-01A2
No
Amy Baxter MD, MMJ Labs LLC
MMJ Labs LLC
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Amy L Baxter, MD MMJ Labs LLC
MMJ Labs LLC
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP