Clinical trial NCT00337870: Painful Procedures in the Emergency Department: A Distraction Intervention (3-5 Year Olds)
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)?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anxiety
Pain
Keywords: Pediatric Anxiety
Pediatric Pain
Emergency room procedures
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
Collaborators: name: Mayday Fund
First posted: 2006-06-20
Enrollment: 131
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: CAMPIS coding of visual pain response video-recorded during the procedure
timeFrame: continuous
Secondary outcomes:
measure: Parental reports of: Child pain ratings (Faces Pain Scale Revised)
timeFrame: post-procedure
measure: Child anxiety ratings
timeFrame: post procedure
measure: CHEOPS analysis
timeFrame: post procedure
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
Study officials:
affiliation: IWK Health Centre
name: Patrick J McGrath, PhD.
role: PRINCIPAL_INVESTIGATOR
References: