Pilot Study of a New Device (Buzzy®) for Procedural Pain Relief During Needle-Related Procedures in Paediatric Patients
Condition: Autoimmune Rheumatologic Disease; Immune Deficiency; Pain Due to Certain Specified Procedures; Child/Adolescent Problems
MeSH terms: Rheumatic Diseases; Collagen Diseases; Immunologic Deficiency Syndromes; Pain, Procedural
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): Buzzy; Topical anaesthetic cream
Intervention type(s): Device; Drug
Intervention description(s): See arm description; See arm description
Other intervention name(s): Maxilene
Intervention MeSH terms: Anesthetics; Anesthetics, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Procedural pain; Procedural anxiety; Pediatrics; Needle-related procedures