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

NCT01152489 | Completed Phase 2

• 2 other identifiers: H09501R44HD056647-01A2
• Study Type: interventional
• Target: 345
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Procedural Pain

Keywords

Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  5 minutes during or immediately after immunizations

Secondary Outcomes (2)

• Pain from immunization using observational measures

  5 minutes immediately following immunization

• Treatment satisfaction

  5 minutes after immunizations

Study Arms (3)

Standard Care

NO INTERVENTION

Immunizations are given with standard care of no pain control

Experimental

ACTIVE COMPARATOR

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

Sham Device

SHAM COMPARATOR

The device without batteries or cold pack held to arm proximal to injections. No formal distraction.

Device: Buzzy: sham device

Interventions

Device: Buzzy 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)

Experimental

Buzzy: sham device 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.

Also known as: Buzzy

Sham Device

Eligibility Criteria

• Age: 4 Months - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• children receiving routine immunizations

You may not qualify if:

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

Sponsors & Collaborators

• MMJ Labs LLC: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

MeSH Terms

Conditions

Pain, Procedural; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Amy Baxter, MD

  MMJ Labs LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 26, 2010
• First Posted: June 29, 2010
• Study Start: April 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: June 22, 2011

Record last verified: 2011-06