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

Not Applicable

Terminated

• Conditions: Pain
• Interventions: Behavioral: Distraction; Behavioral: Routine Care

• Registration Number: NCT00924417
• Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-06-18
• Study First Submitted QC: 2009-06-18
• Study First Posted: 2009-06-19
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-16
• Last Update Posted: 2018-11-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Distraction	Distraction	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.
Routine care	Routine Care	Patient managed as routine care.

Primary Outcome Measures

Name	Time	Method
Faces Pain Scale Revised as reported by child	To be completed 5 minutes after IV placement

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ann & Robert H. Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States