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Pilot Study of a New Device (Buzzy®) for Procedural Pain Relief During Needle-Related Procedures in Paediatric Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02771600
Recruitment Status : Completed
First Posted : May 13, 2016
Last Update Posted : September 27, 2019
Sponsor:
Collaborator:
Toronto-Dominion Bank of Canada Funds for Clinical Research projects.
Information provided by (Responsible Party):
Ariane Ballard, St. Justine's Hospital

Brief Summary:

Needle-related procedures are the most important source of pain and anxiety in pediatric patients. Consequently, needle-phobia and anxiety are common in children with auto-immune disease and immune deficiency and may be barriers to adherence in treatment. The use of a non-pharmacological and easy-to-use approach, like the Buzzy® device, could be an alternative or adjuvant for the management of procedural pain and anxiety of these children during needle-related procedures.

This study aims to determine the feasibility, acceptability and satisfaction of the Buzzy® device for procedural pain and anxiety relief of immunology-rheumatology patients undergoing needle-related procedures. The investigators will compare the Buzzy® device with an anaesthetic cream (Maxilene®) during needle-related procedures. The investigators also plan to assess feasibility outcomes and satisfaction of the nurses and the children with the use of the Buzzy® device. This pilot study should refine or modify the research methodology and improve the intervention being piloted before it's efficacy will be verified within a larger scale-study.

The investigators strongly believe that the use of the Buzzy® device in immunology rheumatology department could optimise procedural pain and anxiety management. Since most of the treatments administered for auto-immune diseases and immune deficiency diseases are through subcutaneous or intramuscular injections, pain and anxiety management using non-pharmacological and/or pharmacological interventions should be prioritized. Given this knowledge, the investigators feel that this pilot study has the potential to contribute to pain and anxiety management of children undergoing needle-related procedures.


Condition or disease Intervention/treatment Phase
Autoimmune Rheumatologic Disease Immune Deficiency Pain Due to Certain Specified Procedures Child/Adolescent Problems Device: Buzzy Drug: Topical anaesthetic cream Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Feasibility, Acceptability and Satisfaction of a New Device (Buzzy®) for Pediatric Procedural Pain and Anxiety Management During Needle-Related Procedures: A Pilot Study.
Actual Study Start Date : June 18, 2018
Actual Primary Completion Date : September 15, 2018
Actual Study Completion Date : September 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Buzzy
Just before the needle-related procedure, the Buzzy®, combining an ice pack and vibration integrated to a plastic bee, will be applied 5 cm above the needle insertion site and will be maintained in place throughout the painful procedure.
Device: Buzzy
See arm description

Active Comparator: Standard Care (Maxilene)
Maxilene topical anaesthetic cream will be applied 30 minutes before the needle-related procedure on the insertion site
Drug: Topical anaesthetic cream
See arm description
Other Name: Maxilene




Primary Outcome Measures :
  1. Post-procedural Pain [ Time Frame: T-2: Immediately after the needle-related procedure ]
    To assess the pain intensity after the needle-related procedure. Measure : Faces Pain Scale-Revised (4-12 years old), Numerical Rating Pain Scale (NRPS) (>12 years old).


Secondary Outcome Measures :
  1. Anxiety level [ Time Frame: T-1: 5 min. before the needle-related procedure, T-2: Immediately after the needle-related procedure ]
    To assess the anxiety level during all the time periods of the study. Measures: Procedure Behaviour Check List (PBCL)

  2. Satisfaction of the parents, children and nurses [ Time Frame: T-3: 15 min. after the needle-related procedure ]
    To assess satisfaction of nurses and children regarding the Buzzy® device. Measures : Questionnaires previously developed by investigators.

  3. Process time of the needle-related procedure [ Time Frame: T-2: Immediately after the needle-related procedure ]
    To assess the feasibility of this study. Measures: Clinical data.



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Ages Eligible for Study:   4 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: We wil include children:

  • Between the ages of 4 and 17 years old
  • Who have a follow-up at the Immunology-Rheumatology Clinic
  • Who require a s/c injection or IM injection or venipuncture or IV catheter insertion
  • Who understand and speak French or English
  • Who have at least one parent who understand, read and talk French or English

Exclusion Criteria: We will exclude children:

  • With a diagnosed neuro-cognitive disability that precludes patients from assenting and participating to the study
  • Who are unable to self-report pain

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02771600


Locations
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Canada, Quebec
CHU Ste-Justine's
Montréal, Quebec, Canada
Sponsors and Collaborators
St. Justine's Hospital
Toronto-Dominion Bank of Canada Funds for Clinical Research projects.
Investigators
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Principal Investigator: Sylvie Le May, PhD CHU Ste-Justine's
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Responsible Party: Ariane Ballard, Doctoral student, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT02771600    
Other Study ID Numbers: 4137
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ariane Ballard, St. Justine's Hospital:
Procedural pain
Procedural anxiety
Pediatrics
Needle-related procedures
Additional relevant MeSH terms:
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Rheumatic Diseases
Collagen Diseases
Immunologic Deficiency Syndromes
Pain, Procedural
Immune System Diseases
Pain
Neurologic Manifestations
Connective Tissue Diseases
Musculoskeletal Diseases
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents