NCT01960166

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2013

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2019

Completed
Last Updated

April 26, 2023

Status Verified

April 1, 2023

Enrollment Period

5.9 years

First QC Date

October 8, 2013

Last Update Submit

April 24, 2023

Conditions

Pain Response

Outcome Measures

Primary Outcomes (1)

  • Score on pain scale

    after procedure

Study Arms (2)

Active distraction

EXPERIMENTAL

Child will use Ipad as active distraction

Behavioral: Active Distraction

Passive Distraction

EXPERIMENTAL

Child will watch movie as passive distraction (control)

Behavioral: Passive Distraction

Interventions

Active DistractionBEHAVIORAL

iPad will be used as active distraction

Active distraction
Passive DistractionBEHAVIORAL

child will watch TV as passive distraction

Passive Distraction

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Study Officials

  • Lawrence Gray, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2013

First Posted

October 10, 2013

Study Start

March 1, 2013

Primary Completion

January 21, 2019

Study Completion

January 21, 2019

Last Updated

April 26, 2023

Record last verified: 2023-04

Locations

US(1)