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

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.

Conditions

• Autoimmune Rheumatologic Disease
• Immune Deficiency
• Pain Due to Certain Specified Procedures
• Child/Adolescent Problems

Interventions

DEVICE

Buzzy

See arm description

DRUG

Topical anaesthetic cream

See arm description

Sponsors & Collaborators

• Toronto-Dominion Bank of Canada Funds for Clinical Research projects.

  collaborator UNKNOWN

• St. Justine's Hospital

  lead OTHER

Principal Investigators

• Sylvie Le May, PhD · CHU Ste-Justine's

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

4 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-06-18

Primary Completion

2018-09-15

Completion

2018-09-15

Countries

• Canada

Study Locations