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

November 16, 2018 updated by: Elizabeth C. Powell, Ann & Robert H Lurie Children's Hospital of Chicago

A Distraction Protocol for Peripheral 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 Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Ann & Robert H. Lurie Children's Hospital of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 9 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: Routine care
Patient managed as routine care.
Behavioral: Routine Care
Parent given placebo intervention that entails brief information about what is routine care for intravenous line placement in the emergency department

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
5 minutes after IV completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Investigators

  • Principal Investigator: Elizabeth Powell, MD, MPH, Ann & Robert H Lurie Children's Hospital of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

June 18, 2009

First Submitted That Met QC Criteria

June 18, 2009

First Posted (Estimate)

June 19, 2009

Study Record Updates

Last Update Posted (Actual)

November 20, 2018

Last Update Submitted That Met QC Criteria

November 16, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMRCIRB#2008-13630

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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