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Active vs Passive Distraction on Procedural Pain in the Pediatric Emergency Department

Primary Purpose

Pain Response

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Distraction
Passive Distraction
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain Response

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy pediatric patients in the University of Chicago emergency department who are undergoing insertion of a peripheral intravenous line, intramuscular injection, fingerstick, subcutaneous injection, laceration repair (sutures, tissue adhesive, and staples), nail avulsion, or abscess incision and drainage.

Exclusion Criteria:

Non-English speaking, over the age of 18 trauma, have come in for asthma-related complaints, are being resuscitated, are neurosurgical/neurology/seizure patients, or patients in whom use of distraction would interfere with the procedure

Sites / Locations

  • U of Chicago Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Active distraction

Passive Distraction

Arm Description

Child will use Ipad as active distraction

Child will watch movie as passive distraction (control)

Outcomes

Primary Outcome Measures

Score on pain scale

Secondary Outcome Measures

Full Information

First Posted
October 8, 2013
Last Updated
April 24, 2023
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT01960166
Brief Title
Active vs Passive Distraction on Procedural Pain in the Pediatric Emergency Department
Official Title
Impact of Active vs Passive Distraction on Procedural Pain/Distress in the Pediatric Emergency
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2013 (Actual)
Primary Completion Date
January 21, 2019 (Actual)
Study Completion Date
January 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators proposed study will investigate the efficacy of tablet computer distraction as an analgesic for the pain associated with various painful procedures in the emergency department. Since prior studies have shown that distraction by a parent or nurse can be an effective analgesic, there is reason to believe that tablet computer distraction will similarly reduce pain. Participants in the control group will receive a cartoon on the TV monitor in the patient room, while participants in the study group will receive a more immersive distraction of playing a game or watching a cartoon (for children too young to play a game) on a tablet computer. Data from this study will help inform best practices for administering painful procedures in a way that minimizes pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Response

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active distraction
Arm Type
Experimental
Arm Description
Child will use Ipad as active distraction
Arm Title
Passive Distraction
Arm Type
Experimental
Arm Description
Child will watch movie as passive distraction (control)
Intervention Type
Behavioral
Intervention Name(s)
Active Distraction
Intervention Description
iPad will be used as active distraction
Intervention Type
Behavioral
Intervention Name(s)
Passive Distraction
Intervention Description
child will watch TV as passive distraction
Primary Outcome Measure Information:
Title
Score on pain scale
Time Frame
after procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy pediatric patients in the University of Chicago emergency department who are undergoing insertion of a peripheral intravenous line, intramuscular injection, fingerstick, subcutaneous injection, laceration repair (sutures, tissue adhesive, and staples), nail avulsion, or abscess incision and drainage. Exclusion Criteria: Non-English speaking, over the age of 18 trauma, have come in for asthma-related complaints, are being resuscitated, are neurosurgical/neurology/seizure patients, or patients in whom use of distraction would interfere with the procedure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence Gray, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
U of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

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Active vs Passive Distraction on Procedural Pain in the Pediatric Emergency Department

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