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

Primary Purpose

Procedural Pain

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Device: Buzzy
Buzzy: sham device
Sponsored by
MMJ Labs LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Procedural Pain focused on measuring Pain

Eligibility Criteria

4 Months - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • children receiving routine immunizations

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Active Comparator

    Sham Comparator

    Arm Label

    Standard Care

    Experimental

    Sham Device

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    Treatment satisfaction
    10 item scale ranging from "strongly agree" to "strongly disagree" with ten parameters of satisfaction with the methods and concepts of immunization.

    Full Information

    First Posted
    June 26, 2010
    Last Updated
    June 21, 2011
    Sponsor
    MMJ Labs LLC
    Collaborators
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01152489
    Brief Title
    A Test of the Effectiveness of a Device and Distraction for Pediatric Immunization Pain
    Official Title
    Phase II Study of the Effectiveness of a Device and Distraction for Pediatric Immunization Pain in Multiple Age Groups
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2010 (undefined)
    Primary Completion Date
    April 2011 (Actual)
    Study Completion Date
    April 2011 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    MMJ Labs LLC
    Collaborators
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Procedural Pain
    Keywords
    Pain

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    345 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard Care
    Arm Type
    No Intervention
    Arm Description
    Immunizations are given with standard care of no pain control
    Arm Title
    Experimental
    Arm Type
    Active Comparator
    Arm Description
    Vibrating device with cold pack held to arm proximal to injections within the same dermatome; caretakers offered and instructed in use of distraction cards.
    Arm Title
    Sham Device
    Arm Type
    Sham Comparator
    Arm Description
    The device without batteries or cold pack held to arm proximal to injections. No formal distraction.
    Intervention Type
    Device
    Intervention Name(s)
    Device: Buzzy
    Other Intervention Name(s)
    Buzzy(R), Flippits(TM)
    Intervention Description
    "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.
    Intervention Type
    Device
    Intervention Name(s)
    Buzzy: sham device
    Other Intervention Name(s)
    Buzzy
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Pain of immunization
    Description
    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
    Secondary Outcome Measure Information:
    Title
    Pain from immunization using observational measures
    Description
    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
    Title
    Treatment satisfaction
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Months
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: children receiving routine immunizations Exclusion Criteria: no caregiver present chronic illness requiring frequent injections clear cognitive impairments affecting communication
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Amy Baxter, MD
    Organizational Affiliation
    MMJ Labs LLC
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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