Painful Procedures in the Emergency Department: A Distraction Intervention (3-5 Year Olds)

NCT ID: NCT00337870

Last Updated: 2013-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2009-08-31

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 Child-Adult Medical Procedures Interaction Scale (CAMPIS) coding of the video-taped pain response of the research participants (3-5 years old).

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 (3-5 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.

Conditions

Anxiety; Pain

Keywords

Pediatric Anxiety; Pediatric Pain; Emergency room procedures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

50% randomized to receive distraction intervention during painful procedure

Group Type: EXPERIMENTAL

PAT

Intervention Type: BEHAVIORAL

Cognitive-Behavioral/Relaxation Intervention

Control

50% RANDOMIZED TO RECEIVE NO INTERVENITON

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PAT

Cognitive-Behavioral/Relaxation Intervention

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Participants will be eligible for this study if they:

• Are between 3-5 years of age
• Are presenting in the IWK Emergency Department requiring venipuncture for blood collection or intravenous (IV) initiation.
• Are able to read and speak English
• Provide written parental authorization

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
• Require sedation for the venipuncture as determined by the ED staff

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayday Fund

OTHER

Sponsor Role: collaborator

IWK Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick J McGrath, PhD.

Role: PRINCIPAL_INVESTIGATOR

IWK Health Centre

Locations

IWK Health Centre

Halifax, Nova Scotia, Canada

Countries

Canada

Other Identifiers

Mayday grant

Identifier Type: -

Identifier Source: secondary_id

3416

Identifier Type: -

Identifier Source: org_study_id