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.
