Viewing Study NCT00338364



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Last Modification Date: 2024-10-26 @ 9:25 AM
Study NCT ID: NCT00338364
Status: COMPLETED
Last Update Posted: 2013-09-12
First Post: 2006-06-15

Brief Title: Painful Procedures in the Emergency Department A Distraction Intervention
Sponsor: IWK Health Centre
Organization: IWK Health Centre

Study Overview

Official Title: Painful Procedures in the Emergency DepartmentDoes a Formal Program in Distracting Techniques for Parents and Children Reduce Pain and Anxiety in Children
Status: COMPLETED
Status Verified Date: 2013-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: ERPain
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 agewho 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
Mayday grant None None None