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

NCT00924417 | Terminated DMC

• 1 other identifier: CMRCIRB#2008-13630
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Pain associated with peripheral intravenous line placement

Outcome Measures

Primary Outcomes (1)

• Faces Pain Scale Revised as reported by child

  To be completed 5 minutes after IV placement

Secondary Outcomes (1)

• 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

Study Arms (2)

Distraction

EXPERIMENTAL

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

Routine care

OTHER

Patient managed as routine care.

Behavioral: Routine Care

Interventions

Routine Care BEHAVIORAL

Parent given placebo intervention that entails brief information about what is routine care for intravenous line placement in the emergency department

Routine care

Distraction BEHAVIORAL

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.

Distraction

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Ages 4 - 9
• Requiring IV placement for medical care in emergency department
• Child cognitively normal

You may not qualify if:

• No significant chronic medical conditions
• No IV in past 3 years

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead

Study Sites (1)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Osteogenesis, Distraction

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bone Lengthening; Orthopedic Procedures; Surgical Procedures, Operative

Study Officials

• Elizabeth Powell, MD, MPH

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: June 18, 2009
• First Posted: June 19, 2009
• Study Start: January 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: November 20, 2018

Record last verified: 2018-11

Locations

US (1)