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

Impact of Active vs Passive Distraction on Procedural Pain/Distress in the Pediatric Emergency

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.

Study Overview

• Status: Completed
• Conditions: Pain Response
• Intervention / Treatment: Behavioral: Active Distraction; Behavioral: Passive Distraction

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • U of Chicago Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active distraction; Child will use Ipad as active distraction	Behavioral: Active Distraction; iPad will be used as active distraction
Experimental: Passive Distraction; Child will watch movie as passive distraction (control)	Behavioral: Passive Distraction; child will watch TV as passive distraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Score on pain scale	after procedure

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Lawrence Gray, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2013
• Primary Completion (Actual): January 21, 2019
• Study Completion (Actual): January 21, 2019

Study Registration Dates

• First Submitted: October 8, 2013
• First Submitted That Met QC Criteria: October 9, 2013
• First Posted (Estimate): October 10, 2013

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Emergencies; Pain, Procedural
• Other Study ID Numbers: 12-2254