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
  Purpose

A vibrating cold pack placed proximal to the site of immunization will decrease the pain of routine preschool immunizations when compared to standard care.


Condition Intervention
Pain
Device: Buzzy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Relieving Pediatric Immunization Pain Using A Reusable Personal Device

Further study details as provided by MMJ Labs LLC:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 60
Study Start Date: January 2009
Estimated Study Completion Date: July 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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 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.

  Eligibility

Ages Eligible for Study:   4 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00910611

Locations
United States, Georgia
Sandy Springs Pediatrics and Adolescent Medicine
Atlanta, Georgia, United States, 30342
Sponsors and Collaborators
MMJ Labs LLC
Investigators
Principal Investigator: Amy L Baxter, MD MMJ Labs LLC
  More Information

No publications provided

Responsible Party: Amy Baxter MD, MMJ Labs LLC
ClinicalTrials.gov Identifier: NCT00910611     History of Changes
Other Study ID Numbers: 08-028, 1R44HD056647-01A2
Study First Received: March 13, 2009
Last Updated: June 24, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by MMJ Labs LLC:
pediatric
immunization
pain
analgesia
Immunization pain

ClinicalTrials.gov processed this record on August 26, 2014