Painful Procedures in the Emergency Department: A Distraction Intervention (3-5 Year Olds) (ERPain)
Recruitment status was Recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | June 15, 2006 | ||||||||
| Last Updated Date | August 7, 2009 | ||||||||
| Start Date ICMJE | March 2006 | ||||||||
| Estimated Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
CAMPIS coding of visual pain response video-recorded during the procedure [ Time Frame: continuous ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
CAMPIS coding of visual pain response video-recorded during the procedure | ||||||||
| Change History | Complete list of historical versions of study NCT00337870 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Painful Procedures in the Emergency Department: A Distraction Intervention (3-5 Year Olds) | ||||||||
| Official Title ICMJE | 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)? | ||||||||
| 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). |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: PAT
Cognitive-Behavioral/Relaxation Intervention |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 168 | ||||||||
| Estimated Completion Date | October 2009 | ||||||||
| Estimated Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Participants will be eligible for this study if they:
Exclusion Criteria: Participants will be excluded for this study if they:
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| Gender | Both | ||||||||
| Ages | 3 Years to 5 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00337870 | ||||||||
| Other Study ID Numbers ICMJE | 3416, Mayday grant | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Patrick McGrath, IWK Health Centre | ||||||||
| Study Sponsor ICMJE | IWK Health Centre | ||||||||
| Collaborators ICMJE | The Mayday Foundation | ||||||||
| Investigators ICMJE |
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| Information Provided By | IWK Health Centre | ||||||||
| Verification Date | July 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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