Pilot Study of a New Device (Buzzy®) for Procedural Pain Relief During Needle-Related Procedures in Paediatric Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02771600|
Recruitment Status : Completed
First Posted : May 13, 2016
Last Update Posted : September 27, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Autoimmune Rheumatologic Disease Immune Deficiency Pain Due to Certain Specified Procedures Child/Adolescent Problems||Device: Buzzy Drug: Topical anaesthetic cream||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Feasibility, Acceptability and Satisfaction of a New Device (Buzzy®) for Pediatric Procedural Pain and Anxiety Management During Needle-Related Procedures: A Pilot Study.|
|Actual Study Start Date :||June 18, 2018|
|Actual Primary Completion Date :||September 15, 2018|
|Actual Study Completion Date :||September 15, 2018|
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.
See arm description
Active Comparator: Standard Care (Maxilene)
Maxilene topical anaesthetic cream will be applied 30 minutes before the needle-related procedure on the insertion site
Drug: Topical anaesthetic cream
See arm description
Other Name: Maxilene
- Post-procedural Pain [ Time Frame: T-2: Immediately after the needle-related procedure ]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).
- Anxiety level [ Time Frame: T-1: 5 min. before the needle-related procedure, T-2: Immediately after the needle-related procedure ]To assess the anxiety level during all the time periods of the study. Measures: Procedure Behaviour Check List (PBCL)
- Satisfaction of the parents, children and nurses [ Time Frame: T-3: 15 min. after the needle-related procedure ]To assess satisfaction of nurses and children regarding the Buzzy® device. Measures : Questionnaires previously developed by investigators.
- Process time of the needle-related procedure [ Time Frame: T-2: Immediately after the needle-related procedure ]To assess the feasibility of this study. Measures: Clinical data.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02771600
|Montréal, Quebec, Canada|
|Principal Investigator:||Sylvie Le May, PhD||CHU Ste-Justine's|