A Distraction Protocol for Peripheral Intravenous (IV) Placement in the Pediatric Emergency Department

Study Overview
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Brief Summary
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This is a randomized, controlled trial of a distraction protocol for peripheral intravenous line placement in the pediatric emergency department. Patients and parents will be randomized to one of two interventions: routine care or a teaching session about the cognitive technique known as distraction. The study seeks to enroll children ages 4-9, who are cognitively normal, who are without significant chronic medical illness, who are receiving intravenous line placement as part of routine care in the pediatric emergency department. Study investigators hypothesize that patients in the intervention group will report less pain than patients in the control group.

Detailed Description
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Routine care patients will have intravenous lines placed in the usual manner. Intervention patient families will have a teaching session about distraction techniques, and distraction will be used during the intravenous line placement.

Official Title
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A Distraction Protocol for Peripheral IV Placement in the Pediatric Emergency Department

Conditions
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Pain

Intervention / Treatment
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* Behavioral: Routine Care
* Behavioral: Distraction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 4 - 9 Requiring IV placement for medical care in emergency department Child cognitively normal Exclusion Criteria: No significant chronic medical conditions No IV in past 3 years

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Distraction<br>Parent given brief teaching session on concept of distraction, and parent and child given 3 distraction toys/tools to assist with peripheral intravenous line placement. | Behavioral: Distraction<br>* Parent given brief information about the cognitive behavioral technique known as distraction. Parent and child then given 3 distraction toys/tools to assist with peripheral intravenous line placement.<br>|
| Other: Routine care<br>Patient managed as routine care. | Behavioral: Routine Care<br>* Parent given placebo intervention that entails brief information about what is routine care for intravenous line placement in the emergency department<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Faces Pain Scale Revised as reported by child |  | To be completed 5 minutes after IV placement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scales to be completed by parent in order to measure: parent distress, patient/child pain, patient/child distress |  | 5 minutes after IV completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain associated with peripheral intravenous line placement