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Painful Procedures in the Emergency Department: A Distraction Intervention (ERPain)

Primary Purpose

Pediatric Pain and Anxiety

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
PAT
Sponsored by
IWK Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Pain and Anxiety focused on measuring Pediatric pain, Pediatric anxiety, Painful procedures

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Participants will be eligible for this study if they: are between 6-12 years of age are presenting in the IWK Emergency Department who require a venipuncture for blood collection or IV initiation. are able to read and speak english provide written parental authorization and verbal child assent Exclusion Criteria: Participants will be excluded for this study if they: are in critical condition as determined by ED staff are in significant pain for other reasons other than the venipuncture have severe cognitive delay who require sedation for the venipuncture as determined by the ED staff

Sites / Locations

  • IWK Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment

Control

Arm Description

50% randomized to receive distraction during painful procedure

50% randomized to receive no distraction during painful procedure

Outcomes

Primary Outcome Measures

CAMPIS coding of visual pain response video-recorded during the procedure

Secondary Outcome Measures

Child pain ratings (Faces Pain Scale Revised)
Child anxiety ratings
CHEOPS analysis

Full Information

First Posted
June 15, 2006
Last Updated
September 11, 2013
Sponsor
IWK Health Centre
Collaborators
Mayday Fund
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1. Study Identification

Unique Protocol Identification Number
NCT00338364
Brief Title
Painful Procedures in the Emergency Department: A Distraction Intervention
Acronym
ERPain
Official Title
Painful Procedures in the Emergency Department:Does a Formal Program in Distracting Techniques for Parents and Children Reduce Pain and Anxiety in Children?
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IWK Health Centre
Collaborators
Mayday Fund

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is designed to assess the effectiveness of the video-based intervention over and above current standard practice for pain control in the pediatric emergency department (ED). This is a single-center trial based at the IWK Health Centre. The primary outcome will be based on the CAMPIS coding of the video-taped pain response of the research participants.
Detailed Description
The purpose of this study is to determine if the pain and anxiety that children experience when they have venipuncture procedures performed can be reduced by a video-based distraction and coping strategy intervention. An instructional video has been designed to educate parents and children about what is going to happen during the venipuncture procedure; to teach coping skills that can be used before and during the painful procedure; and to provide distraction during the procedure by using an entertaining video segment. Approximately 168 children (6-12 years of age)who are seen in the IWK ED requiring venipunctures for blood collection or IV starts will be randomized. PArent and child training in distraction and coping strategies will be provided by means of a self-administered video-delivery via a portable DVD player. Fifty percent of the eligible participants will receive the distraction and coping strategies intervention and 50% will receive the standard medical care provided by the IWK ED. Those receiving standard care will be evaluated for outcome results and then be compared to the intervention group. It is expected that children who receive the intervention will report less pain and anxiety associated with venipunctures than those who receive standard care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Pain and Anxiety
Keywords
Pediatric pain, Pediatric anxiety, Painful procedures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
189 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
50% randomized to receive distraction during painful procedure
Arm Title
Control
Arm Type
No Intervention
Arm Description
50% randomized to receive no distraction during painful procedure
Intervention Type
Behavioral
Intervention Name(s)
PAT
Intervention Description
Coping and Distraction Intervention
Primary Outcome Measure Information:
Title
CAMPIS coding of visual pain response video-recorded during the procedure
Time Frame
continuous
Secondary Outcome Measure Information:
Title
Child pain ratings (Faces Pain Scale Revised)
Time Frame
post procedure
Title
Child anxiety ratings
Time Frame
post procedure
Title
CHEOPS analysis
Time Frame
post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants will be eligible for this study if they: are between 6-12 years of age are presenting in the IWK Emergency Department who require a venipuncture for blood collection or IV initiation. are able to read and speak english provide written parental authorization and verbal child assent Exclusion Criteria: Participants will be excluded for this study if they: are in critical condition as determined by ED staff are in significant pain for other reasons other than the venipuncture have severe cognitive delay who require sedation for the venipuncture as determined by the ED staff
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick J. McGrath, PhD.
Organizational Affiliation
IWK Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada

12. IPD Sharing Statement

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Painful Procedures in the Emergency Department: A Distraction Intervention

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