A Distraction Protocol for Peripheral Intravenous (IV) Placement in the Pediatric Emergency Department
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
|Official Title:||A Distraction Protocol for Peripheral IV Placement in the Pediatric Emergency Department|
- Faces Pain Scale Revised as reported by child [ Time Frame: To be completed 5 minutes after IV placement ] [ Designated as safety issue: No ]
- Visual Analog Scales to be completed by parent in order to measure: parent distress, patient/child pain, patient/child distress [ Time Frame: 5 minutes after IV completion ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||May 2010|
|Estimated Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
No Intervention: Routine Care
Parent given brief description of what entails routine care with peripheral IV placement.
Behavioral: Routine Care
Parent given placebo intervention that entails brief information about what is routine care for intravenous line placement in the emergency department
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00924417
|United States, Illinois|
|Children's Memorial Hospital|
|Chicago, Illinois, United States, 60614|
|Principal Investigator:||Rachel E Tuuri, MD||Ann & Robert H Lurie Children's Hospital of Chicago|
|Principal Investigator:||Elizabeth Powell, MD, MPH||Ann & Robert H Lurie Children's Hospital of Chicago|