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

Pain Clinical Trial

— 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 (3-5 Year Olds)?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00337870
• Other study ID #: 3416
• Secondary ID: Mayday grant
• Status: Completed
• Phase: Phase 2
• First received: June 15, 2006
• Last updated: September 11, 2013
• Start date: March 2006
• Est. completion date: August 2009

Study information

• Verified date: September 2013
• Source: IWK Health Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 5 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Emergencies
• Pain

Intervention

Behavioral:
• PAT
Cognitive-Behavioral/Relaxation Intervention

Locations

Country	Name	City	State
Canada	IWK Health Centre	Halifax	Nova Scotia

Sponsors (2)

Lead Sponsor	Collaborator
IWK Health Centre	Mayday Fund

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CAMPIS coding of visual pain response video-recorded during the procedure		continuous	No
Secondary	Parental reports of: Child pain ratings (Faces Pain Scale Revised)		post-procedure	No
Secondary	Child anxiety ratings		post procedure	No
Secondary	CHEOPS analysis		post procedure	No