Pain Perception of Children and Youth Receiving Non-sedated Botulinum Toxin-A Injections Using the Buzzy®

Study Overview
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Brief Summary
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The use of Botulinum toxin injections (BoNT-A) has become a standard therapy for children and youth who suffer from stiffness of their muscles due to a neurological problem. These injections are given into each muscles which require treatment, which often means receiving multiple injections in one session. Intramuscular injections are typically painful. Treatment can be provided unsedated and then should incorporate distraction and relaxation techniques, or can be alternatively be provided with the use of sedation. To improve the pain experience the investigators want to assess the feasibility and impact on the pain perception when using a vibration device called the Buzzy during BoNT-A injections. The Buzzy creates a vibration that is applied over the injection site for 30 seconds before the injection and will be continued just above the injection site during the injection. The Buzzy has been shown to help reduce pain in procedures such as i.v. insertions and immunizations, but has not been tested in children and youth receiving multiple BoNT-A injections.

Detailed Description
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Children and youth who receive hypertonia treatment with non-sedated BoNT-A injection will be invited to participate in this clinical trial. The patients will be randomized to receiving the injection with the Buzzy versus the control group without the Buzzy. Both groups will still receive their typical supports that will include their choice of local anesthetic cream, relaxation and distraction techniques. Randomization will be stratified for the ability to self report. Measures to capture the pain will include self report of pain, by using the Face Pain Scale revised (FPSr) in all participants who are able to self report. In addition all participants will be evaluated by the use of the Face, Legs, Activity, Cry and Consolability scale (FLACC scale), an observational tool validated to capture pain responses. The investigators will also include measurement of heart rate at rest, during and after the intervention.

Official Title
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Pain Perception of Children and Youth Receiving Non-sedated Botulinum Toxin-A Injections Using the Buzzy®

Conditions
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Pain

Intervention / Treatment
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* Device: Buzzy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any child and youth who receives non-sedated Botulinum toxin-A injections and is interested and consenting to using the Buzzy Exclusion Criteria: Patients receiving Botulinum Toxin-A injections under sedation Patients younger than 2 years or older than 18 years.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buzzy<br>Participants will use the Buzzy, a small vibration device during their Botulinum toxin treatments. The Buzzy will be held over the injection site for 30 sec prior to the injection, then will be moved more rostral during the actual injection. The Buzzy will be applied in the same fashion to each targeted muscle. | Device: Buzzy<br>* The Buzzy will be applied for 30 seconds over the area that is going to be injected, then during the actual injection the Buzzy will be moved rostrally and continuously used during the injection. When the injection is completed the Buzzy is positioned in the same way over the next injection site.<br>* Other names: vibration therapy;|
| No Intervention: control - no Buzzy<br>Participants in the control group will receive their regular Botulinum toxin treatment without the use of the Buzzy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Faces Pain Scale revised | pain will be assessed by the use of the FPSr, a tool which was validated and been shown to be reliable in children and youth age 4 years and up. | The participants will be asked to rate their pain 3 minutes after the treatment. This will take about 2-5 minutes. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FLACC scale (base line) | The FLACC scale is a validated observational measure to rate bodily responses to pain. The scale has five items. Each item observes one area/activity and includes the following: face, legs, activity, cry and consolability. Each item can get a score of 0 (no response) to 2 (most response) so that the total FLACC score can vary from 0-10. | Baseline: Participants will be observed and rated on the FLACC scale 1 minute prior to the intervention. | 
| FLACC scale (during intervention) | The FLACC scale is a validated observational measure to rate bodily responses to pain. The scale has five items. Each item observes one area/activity and includes the following: face, legs, activity, cry and consolability. Each item can get a score of 0 (no response) to 2 (most response) so that the total FLACC score can vary from 0-10. | Participants will be observed and rated on the FLACC scale during the intervention. Intervention time is typically 1-3 minutes. | 
| FLACC scale (after intervention) | The FLACC scale is a validated observational measure to rate bodily responses to pain. The scale has five items. Each item observes one area/activity and includes the following: face, legs, activity, cry and consolability. Each item can get a score of 0 (no response) to 2 (most response) so that the total FLACC score can vary from 0-10. | Participants will be observed and rated on the FLACC scale 5 minutes after the intervention. | 
| Heart rate (baseline) | Heart rate will be measured before, during and after the intervention. Heart rate has been shown to be a biological marker of stress and pain. | The heart rate will be captured 1 minute before the intervention | 
| Heart rate (during intervention) | Heart rate will be measured before, during and after the intervention. Heart rate has been shown to be a biological marker of stress and pain. | The heart rate will be captured during the intervention. | 
| Heart rate (after intervention) | Heart rate will be measured before, during and after the intervention. Heart rate has been shown to be a biological marker of stress and pain. | The heart rate will be captured 5 minutes after the intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Pediatrics, Botulinum Toxin injections, Buzzy