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

NCT ID: NCT01960166

Last Updated: 2023-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-01

Study Completion Date

2019-01-21

Brief Summary

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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.

Detailed Description

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Conditions

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Pain Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Active distraction

Child will use Ipad as active distraction

Group Type EXPERIMENTAL

Active Distraction

Intervention Type BEHAVIORAL

iPad will be used as active distraction

Passive Distraction

Child will watch movie as passive distraction (control)

Group Type EXPERIMENTAL

Passive Distraction

Intervention Type BEHAVIORAL

child will watch TV as passive distraction

Interventions

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Active Distraction

iPad will be used as active distraction

Intervention Type BEHAVIORAL

Passive Distraction

child will watch TV as passive distraction

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lawrence Gray, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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U of Chicago Medical Center

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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12-2254

Identifier Type: -

Identifier Source: org_study_id

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