A Distraction Protocol for Peripheral Intravenous (IV) Placement in the Pediatric Emergency Department
This study is enrolling participants by invitation only.
Sponsor:
Ann & Robert H Lurie Children's Hospital of Chicago
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
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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
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 |
Additional relevant MeSH terms:
|
Emergencies Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on June 17, 2013