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

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)?

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00337870
Acronym
ERPain
Enrollment
131
Registered
2006-06-20
Start date
2006-03-31
Completion date
2009-08-31
Last updated
2013-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Pain

Keywords

Pediatric Anxiety, Pediatric Pain, Emergency room procedures

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.

Interventions

BEHAVIORALPAT

Cognitive-Behavioral/Relaxation Intervention

Sponsors

Mayday Fund
CollaboratorOTHER
IWK Health Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
CAMPIS coding of visual pain response video-recorded during the procedurecontinuous

Secondary

MeasureTime frame
Parental reports of: Child pain ratings (Faces Pain Scale Revised)post-procedure
Child anxiety ratingspost procedure
CHEOPS analysispost procedure

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026