Immune Deficiency Clinical Trial
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.
NCT number | NCT02771600 |
Other study ID # | 4137 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 18, 2018 |
Est. completion date | September 15, 2018 |
Verified date | September 2019 |
Source | St. Justine's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | September 15, 2018 |
Est. primary completion date | September 15, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 17 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | CHU Ste-Justine's | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
St. Justine's Hospital | Toronto-Dominion Bank of Canada Funds for Clinical Research projects. |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post-procedural Pain | 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). | T-2: Immediately after the needle-related procedure | |
Secondary | Anxiety level | To assess the anxiety level during all the time periods of the study. Measures: Procedure Behaviour Check List (PBCL) | T-1: 5 min. before the needle-related procedure, T-2: Immediately after the needle-related procedure | |
Secondary | Satisfaction of the parents, children and nurses | To assess satisfaction of nurses and children regarding the Buzzy® device. Measures : Questionnaires previously developed by investigators. | T-3: 15 min. after the needle-related procedure | |
Secondary | Process time of the needle-related procedure | To assess the feasibility of this study. Measures: Clinical data. | T-2: Immediately after the needle-related procedure |
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