Pilot Study of a New Device (Buzzy®) for Procedural Pain Relief During Needle-Related Procedures in Paediatric Patients
Pilot Study of a New Device (Buzzy®) for Procedural Pain Relief During Needle-Related Procedures in Paediatric Patients
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.
Rationale: Procedural pain and anxiety relief of needle-related procedures is a major concern
 for nurses working with Immunology-Rheumatology patients. Treatments for most autoimmune
 diseases and immune deficiencies diseases are administrated by subcutaneous or intramuscular
 injections and these children will go through countless needle-related procedures for a long
 period of their life. Procedural pain and anxiety generates consequences which may be
 physiological, psychological and emotional. Since it is impossible to completely control pain
 and anxiety experienced by pediatric patients during painful procedures, non-pharmacological
 and/or pharmacological interventions should be part of the interventions to provide comfort
 to children. Interventions to decrease physical and emotional impacts of needle-related
 procedures should be an integral part of nursing activities. Most of pain and anxiety
 management methods available for children require much time of staff, which represents
 barriers to their implantation among nursing interventions. Use of a rapid and easy-to-use
 non-pharmacological intervention could overcome these constraints and optimise pain and
 anxiety relief in children. Investigators believe that the Buzzy® device, combining cold and
 vibration, could be an efficient way to improve pain and anxiety management during
 needle-related procedures. To date, no studies have focused on the efficacy of this device on
 pediatric immunology-rheumatology patients.

 Objective: To assess the feasibility, acceptability and satisfaction of a new device (Buzzy®)
 combining the effect of cold and vibration, for procedural pain relief and anxiety during
 needle-related procedures in pediatric immunology-rheumatology patients.

 Methods. Design: This study is a pilot study of a two-group randomized controlled trial
 (RCT). Setting: Immunology-Rheumatology clinic of the CHU Sainte-Justine's (Montreal).
 Inclusion criteria: We will include children: a) between the ages of 4 and 17 years old; b)
 visiting the Immunology-Rheumatology Clinic for a follow-up; c) who require a s/c injection
 or IM injection or venipuncture or IV catheter insertion; d) who understand French or
 English; e) who have at least one parent who understand, read and talk French or English.
 Exclusion criteria: We will exclude children: a) who have a diagnosed neuro-cognitive
 disability that precludes patients from assenting and participating to the study, b) who have
 the inability to self-report pain. Sample size: We expect to recruit 100 participants for
 this pilot study (50 participants per group). Allocations: According to a randomized list,
 patients will be allocated to one of the study group: a) Experimental group: Just before the
 needle-related procedure, the Buzzy® device, 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; or b) Control group: Maxilene® topical anaesthetic
 cream will be applied 30 minutes before the needle-related procedure on the insertion site.
 Primary outcomes: Post-procedural pain and it will be measured with the Faces Pain
 Scale-Revised (FPS-R) (4-12 years old) and the Numerical Pain Rating Scale (NPRS) (>12 years
 old). Secondary outcomes: Post-procedural anxiety and it will be measured with the Procedure
 Behavior Check List (PBCL). We will also assess the satisfaction of nurses and children
 regarding the Buzzy® device. Satisfaction will be measured using questionnaires previously
 developed by investigators. The principal feasibility outcomes will be the recruitment rates,
 the refusal rate, the needle-related procedure rate and the time of the procedure. Study
 times periods: Four study times periods are planned: T-0: before randomization; T-1: 5 min.
 before the needle-related procedure (pre-procedural pain and pre-procedural anxiety); T-2:
 immediately after the needle-related procedure (post-procedural pain and post-procedural
 anxiety); T-3: 15 min. after the needle-related procedure (satisfaction and feasibility
 outcomes). Data analysis: Descriptive statistics will be used for group characteristics.
 Quantitative multivariate analysis will be performed to compare both groups for pre- and
 post-procedural pain and anxiety. Descriptive statistics will be used for report on
 satisfaction and feasibility outcomes. ANCOVA will be used on covariate to increase
 statistical power.

 Relevance: This pilot study will assess the effects of a new device on pain and anxiety level
 of immunology-rheumatology patients during needle-related procedure and will test feasibility
 of the study design as well as acceptability on the new distraction device by patients and
 nurses. This study will refine the research methodology and improve the intervention being
 piloted for a future large-scale study.
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