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

• Status: Completed
• Trial end date: 2018-09-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Justine's Hospital
• Collaborator: Toronto-Dominion Bank of Canada Funds for Clinical Research projects.
• Treatments: Anesthetics; Anesthetics, Local; Lidocaine

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