NCT00337870

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P50-P75 for phase_2 anxiety

Timeline
Completed

Started Mar 2006

Typical duration for phase_2 anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 20, 2006

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

September 12, 2013

Status Verified

September 1, 2013

Enrollment Period

3.4 years

First QC Date

June 15, 2006

Last Update Submit

September 11, 2013

Conditions

AnxietyPain

Keywords

Pediatric AnxietyPediatric PainEmergency room procedures

Outcome Measures

Primary Outcomes (1)

  • CAMPIS coding of visual pain response video-recorded during the procedure

    continuous

Secondary Outcomes (3)

  • Parental reports of: Child pain ratings (Faces Pain Scale Revised)

    post-procedure

  • Child anxiety ratings

    post procedure

  • CHEOPS analysis

    post procedure

Study Arms (2)

Treatment

EXPERIMENTAL

50% randomized to receive distraction intervention during painful procedure

Behavioral: PAT

Control

NO INTERVENTION

50% RANDOMIZED TO RECEIVE NO INTERVENITON

Interventions

PATBEHAVIORAL

Cognitive-Behavioral/Relaxation Intervention

Treatment

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

MeSH Terms

Conditions

Anxiety DisordersPain

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Patrick J McGrath, PhD.

    IWK Health Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2006

First Posted

June 20, 2006

Study Start

March 1, 2006

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

September 12, 2013

Record last verified: 2013-09

Locations

CA(1)