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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Study of the Effectiveness of a Device and Distraction for Pediatric Immunization Pain in Multiple Age Groups

Conditions
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Procedural Pain

Intervention / Treatment
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* Device: Device: Buzzy
* Device: Buzzy: sham device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children receiving routine immunizations Exclusion Criteria: no caregiver present chronic illness requiring frequent injections clear cognitive impairments affecting communication

Ages Eligible for Study
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Minimum Age: 4 Months
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Care<br>Immunizations are given with standard care of no pain control | |
| Active Comparator: Experimental<br>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<br>* 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.<br>* Other names: Flippits(TM);|
| Sham Comparator: Sham Device<br>The device without batteries or cold pack held to arm proximal to injections. No formal distraction. | Device: Buzzy: sham device<br>* 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.<br>* Other names: Buzzy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 minutes immediately following immunization | 
| Treatment satisfaction | 10 item scale ranging from strongly agree to strongly disagree with ten parameters of satisfaction with the methods and concepts of immunization. | 5 minutes after immunizations | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain