- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00337870
Painful Procedures in the Emergency Department: A Distraction Intervention (3-5 Year Olds) (ERPain)
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 Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3K 6R8
- IWK Health Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
50% randomized to receive distraction intervention during painful procedure
|
Cognitive-Behavioral/Relaxation Intervention
|
No Intervention: Control
50% RANDOMIZED TO RECEIVE NO INTERVENITON
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
CAMPIS coding of visual pain response video-recorded during the procedure
Time Frame: continuous
|
continuous
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Child anxiety ratings
Time Frame: post procedure
|
post procedure
|
CHEOPS analysis
Time Frame: post procedure
|
post procedure
|
Parental reports of: Child pain ratings (Faces Pain Scale Revised)
Time Frame: post-procedure
|
post-procedure
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Patrick J McGrath, PhD., IWK Health Centre
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3416
- Mayday grant
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
Clinical Trials on PAT
-
Patagonia Pharmaceuticals, LLCCompletedCongenital IchthyosisUnited States
-
Wake Forest University Health SciencesCompletedChronic Toxic Stress | Developmental/ Behavioral Regression in Young ChildrenUnited States
-
University of PittsburghNational Heart, Lung, and Blood Institute (NHLBI)RecruitingObesity | PreDiabetes | Blood Pressure | Cardiovascular Risk Factor | Physical InactivityUnited States
-
Nationwide Children's HospitalEnrolling by invitationProcedural Pain | Procedural AnxietyUnited States
-
Wonju Severance Christian HospitalDong-A ST Co., Ltd.CompletedObstructive Sleep Apnea | Acute Myocardial InfarctionKorea, Republic of
-
Meir Medical CenterUnknownSymptomatic Congestive Heart FailureIsrael
-
Emory UniversityNational Institute of Neurological Disorders and Stroke (NINDS)Recruiting
-
IWK Health CentreMayday FundCompletedPediatric Pain and AnxietyCanada
-
Washington University School of MedicineNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedObesity | Pregnancy | Weight GainUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)WithdrawnPrimary Myelofibrosis | Polycythemia Vera, Post-Polycythemic Myelofibrosis Phase | Myelofibrosis Transformation in Essential ThrombocythemiaUnited States