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

NCT02771600 | Completed

• 1 other identifier: 4137
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Procedural pain; Procedural anxiety; Pediatrics; Needle-related procedures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Anxiety level

  T-1: 5 min. before the needle-related procedure, T-2: Immediately after the needle-related procedure

• Satisfaction of the parents, children and nurses

  T-3: 15 min. after the needle-related procedure

• Process time of the needle-related procedure

  T-2: Immediately after the needle-related procedure

Study Arms (2)

Buzzy

EXPERIMENTAL

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

Standard Care (Maxilene)

ACTIVE COMPARATOR

Maxilene topical anaesthetic cream will be applied 30 minutes before the needle-related procedure on the insertion site

Drug: Topical anaesthetic cream

Interventions

Buzzy DEVICE

See arm description

Buzzy

Topical anaesthetic cream DRUG

See arm description

Also known as: Maxilene

Standard Care (Maxilene)

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• St. Justine's Hospital: lead
• Toronto-Dominion Bank of Canada Funds for Clinical Research projects.: collaborator

Study Sites (1)

CHU Ste-Justine's

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Immunologic Deficiency Syndromes; Pain, Procedural

Interventions

Maxilene

Condition Hierarchy (Ancestors)

Immune System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sylvie Le May, PhD

  CHU Ste-Justine's

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral student

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: May 13, 2016
• Study Start: June 18, 2018
• Primary Completion: September 15, 2018
• Study Completion: September 15, 2018
• Last Updated: September 27, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)