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

March 18, 2024 updated by: Ronit Mesterman, Hamilton Health Sciences Corporation

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4 K1
        • McMaster Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Buzzy
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
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.
Other Names:
  • vibration therapy
No Intervention: control - no Buzzy
Participants in the control group will receive their regular Botulinum toxin treatment without the use of the Buzzy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Faces Pain Scale revised
Time Frame: The participants will be asked to rate their pain 3 minutes after the treatment. This will take about 2-5 minutes.
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)
Time Frame: Baseline: Participants will be observed and rated on the FLACC scale 1 minute prior to the 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.
Baseline: Participants will be observed and rated on the FLACC scale 1 minute prior to the intervention.
FLACC scale (during intervention)
Time Frame: Participants will be observed and rated on the FLACC scale during the intervention. Intervention time is typically 1-3 minutes.
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)
Time Frame: Participants will be observed and rated on the FLACC scale 5 minutes after the 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)
Time Frame: The heart rate will be captured 1 minute before the 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 1 minute before the intervention
Heart rate (during intervention)
Time Frame: The heart rate will be captured during the 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)
Time Frame: The heart rate will be captured 5 minutes after the 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamilton Health Sciences Corporation

Investigators

  • Principal Investigator: Ronit Mesterman, M.D., McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

October 19, 2014

First Submitted That Met QC Criteria

October 21, 2014

First Posted (Estimated)

October 23, 2014

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • no number yet

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Buzzy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe