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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT00924417
First received: June 18, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Pain
Behavioral: Routine Care
Behavioral: Distraction

Study Type: Interventional
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

Further study details as provided by Ann & Robert H Lurie Children's Hospital of Chicago:

Primary Outcome Measures:
  • Faces Pain Scale Revised as reported by child [ Time Frame: To be completed 5 minutes after IV placement ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
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)
Arms Assigned Interventions
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
Experimental: 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.
Behavioral: Distraction
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.

  Eligibility

Ages Eligible for Study:   4 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00924417

Locations
United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
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
  More Information

No publications provided

Responsible Party: Rachel E Tuuri, MD, Pediatric Emergency Fellow, Children's Memorial Hospital
ClinicalTrials.gov Identifier: NCT00924417     History of Changes
Other Study ID Numbers: CMRCIRB#2008-13630
Study First Received: June 18, 2009
Last Updated: June 18, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Ann & Robert H Lurie Children's Hospital of Chicago:
Pain associated with peripheral intravenous line placement

ClinicalTrials.gov processed this record on October 23, 2014