A Distraction Protocol for Peripheral Intravenous (IV) Placement in the Pediatric Emergency Department

NCT ID: NCT00924417

Last Updated: 2018-11-20

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

TERMINATED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-05-31

Brief Summary

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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.

Detailed Description

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Routine care patients will have intravenous lines placed in the usual manner.

Intervention patient families will have a teaching session about distraction techniques, and distraction will be used during the intravenous line placement.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Distraction

Intervention Type BEHAVIORAL

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.

Routine care

Patient managed as routine care.

Group Type OTHER

Routine Care

Intervention Type BEHAVIORAL

Parent given placebo intervention that entails brief information about what is routine care for intravenous line placement in the emergency department

Interventions

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Routine Care

Parent given placebo intervention that entails brief information about what is routine care for intravenous line placement in the emergency department

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth C. Powell

Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elizabeth Powell, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Ann & Robert H Lurie Children's Hospital of Chicago

Locations

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Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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CMRCIRB#2008-13630

Identifier Type: -

Identifier Source: org_study_id

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