Back to resultsA Distraction Protocol for Peripheral Intravenous (IV) Placement in the Pediatric Emergency Department
Primary Purpose
Pain
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Routine Care
Distraction
Sponsored by
About this trial
This is an interventional supportive care trial for Pain focused on measuring Pain associated with peripheral intravenous line placement
Eligibility 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
Sites / Locations
- Ann & Robert H. Lurie Children's Hospital of Chicago
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Distraction
Routine care
Arm Description
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.
Patient managed as routine care.
Outcomes
Primary Outcome Measures
Faces Pain Scale Revised as reported by child
Secondary Outcome Measures
Visual Analog Scales to be completed by parent in order to measure: parent distress, patient/child pain, patient/child distress
Full Information
NCT ID
NCT00924417
First Posted
June 18, 2009
Last Updated
November 16, 2018
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
1. Study Identification
Unique Protocol Identification Number
NCT00924417
Brief Title
A Distraction Protocol for Peripheral Intravenous (IV) Placement in the Pediatric Emergency Department
Official Title
A Distraction Protocol for Peripheral IV Placement in the Pediatric Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Terminated
Why Stopped
Fellow unable to complete enrollment before completing training.
Study Start Date
January 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Pain associated with peripheral intravenous line placement
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Distraction
Arm Type
Experimental
Arm Description
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.
Arm Title
Routine care
Arm Type
Other
Arm Description
Patient managed as routine care.
Intervention Type
Behavioral
Intervention Name(s)
Routine Care
Intervention Description
Parent given placebo intervention that entails brief information about what is routine care for intravenous line placement in the emergency department
Intervention Type
Behavioral
Intervention Name(s)
Distraction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Faces Pain Scale Revised as reported by child
Time Frame
To be completed 5 minutes after IV placement
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Powell, MD, MPH
Organizational Affiliation
Ann & Robert H Lurie Children's Hospital of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ann & Robert H. Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Distraction Protocol for Peripheral Intravenous (IV) Placement in the Pediatric Emergency Department
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