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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
MMJ Labs LLC
ClinicalTrials.gov Identifier:
NCT01152489
First received: June 26, 2010
Last updated: June 21, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Procedural Pain
Device: Device: Buzzy
Device: Buzzy: sham device
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Phase II Study of the Effectiveness of a Device and Distraction for Pediatric Immunization Pain in Multiple Age Groups

Further study details as provided by MMJ Labs LLC:

Primary Outcome Measures:
  • Pain of immunization [ Time Frame: 5 minutes during or immediately after immunizations ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Pain from immunization using observational measures [ Time Frame: 5 minutes immediately following immunization ] [ Designated as safety issue: No ]
    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.

  • Treatment satisfaction [ Time Frame: 5 minutes after immunizations ] [ Designated as safety issue: No ]
    10 item scale ranging from "strongly agree" to "strongly disagree" with ten parameters of satisfaction with the methods and concepts of immunization.


Estimated Enrollment: 345
Study Start Date: April 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard Care
Immunizations are given with standard care of no pain control
Active Comparator: Experimental
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
"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.
Other Names:
  • Buzzy(R)
  • Flippits(TM)
Sham Comparator: Sham Device
The device without batteries or cold pack held to arm proximal to injections. No formal distraction.
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.
Other Name: Buzzy

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.

  Eligibility

Ages Eligible for Study:   4 Months to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • children receiving routine immunizations

Exclusion Criteria:

  • no caregiver present
  • chronic illness requiring frequent injections
  • clear cognitive impairments affecting communication
  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: NCT01152489

Sponsors and Collaborators
MMJ Labs LLC
Investigators
Principal Investigator: Amy Baxter, MD MMJ Labs LLC
  More Information

No publications provided

Responsible Party: Amy Baxter MD, MMJ Labs LLC
ClinicalTrials.gov Identifier: NCT01152489     History of Changes
Other Study ID Numbers: H09501, R44HD056647-01A2
Study First Received: June 26, 2010
Last Updated: June 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by MMJ Labs LLC:
Pain

ClinicalTrials.gov processed this record on October 02, 2014