- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00924417
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
-
-
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.
|
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.
|
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.
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
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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