Interest of a Musical Intervention on Stress Induced During Botulinum Toxin Injections in Spasticity (MUSIBOT) (MUSIBOT)

May 22, 2025 updated by: University Hospital, Clermont-Ferrand

Interest of a Musical Intervention on Stress Induced During Botulinum Toxin Injections in Spasticity

Botulinum toxin (BT) injections are a painful treatment frequently used to treat spasticity following central neurological damage (stroke, multiple sclerosis, spinal cord injury, head trauma). Tolerance of injections varies from patient to patient. For most patients, the pain experienced during the injection is a major source of stress.

Numerous clinical trials have demonstrated the role of music therapy in pain management. Music therapy uses a "U" shaped technique, allowing the patient to relax in different phases. This system has demonstrated beneficial effects on pain and anxiety in various fields, such as chronic and acute pain, Alzheimer's disease, fibromyalgia and neurological pain. Given the painful nature of spasticity and anxiety treatment, we aim to use a musical intervention to help patients cope better with injections.

The primary objective of the study is to investigate the effect of exposure to a musical intervention session during botulinum toxin injections, on injection-induced stress (heart rate variability).

Secondary objectives:

To study the effect of exposure to a musical intervention session during botulinum toxin injections, during the visit to injections #1, in terms of:

  • Injection-induced stress for HRV parameters other than LF/HF
  • Injection-induced pain
  • Injection anxiety
  • Patient satisfaction
  • Effect of musical intervention on the medical procedure performed (botulinum toxin injections) expressed by the doctor at the end of the session.

To study the effect of exposure to a musical intervention session, during injections visit n°2, in order to evaluate the effect of repeated exposure to a musical intervention session, in terms of :

  • Injection-induced stress for HRV parameters other than LF/HF
  • Injection-induced pain
  • Injection anxiety
  • Patient satisfaction
  • Effect of musical intervention on the medical procedure performed (botulinum toxin injections) expressed by the physician at the end of the session.

The hypothesis of this research is that a responsive musical intervention can, in adults, reduce the stress induced by botulinum toxin injections.

Patients will be selected from the cohort of patients regularly treated for botulinum toxin injections in the Physical and Rehabilitation Medicine (PRM) department at Clermont-Ferrand University Hospital. Botulinum toxin injections will take place in the PRM department. Each patient will participate in the study for a maximum of 4 months.

This study will be carried out in patients receiving regular botulinum toxin injections to treat spasticity. The first injection will be given with (IM-IM) or without musical intervention (CT-IM), depending on the randomization group, followed by the next injection with musical intervention. Patients will be able to choose the style of music (Jazz, Classical, Electronic, R&B, Ambient, Rock, etc.) that appeals to them in order to benefit from a minimum 20-minute session of musical intervention (duration varying according to the number of injections to be performed).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

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 Contact

Study Locations

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients, male or female, suffering from spasticity of neurological origin (multiple sclerosis, stroke, head trauma, etc.) and eligible for botulinum toxin injection treatments.
  • Patients with known pain and/or anxiety
  • Able to give informed consent to participate in research
  • Enrolled in a French Social Security system

Exclusion Criteria:

  • Contraindication to musical intervention (severe hearing impairment, unstabilized psychotic disorders, history of auditory trauma)
  • Major cognitive impairment
  • Any medical condition deemed by the investigator to be incompatible with the research.
  • Indication for MEOPA sedation during botulinum toxin injection sessions
  • Medication or medical conditions likely to interfere with heart rate variability during the study: beta-blockers, anti-arrhythmics, anxiolytics, benzodiazepines, anti-hypertensives and calcium antagonists.
  • Pregnant or breast-feeding women
  • Refusal to participate

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group CT-IM : standard condition
The control group (CT-IM) will receive no special devices, apart from the Polar H10 heart rate monitor. This group will perform botulinum toxin injections as usual in the department, with the same assessments as the IM-IM group.
Experimental: Intervention group : IM-IM
The intervention group (IM-IM) will receive a tablet and headphones to listen to music during the toxin injections. Then, during the waiting time, the patient, with or without assistance, will choose the music they wish to listen to, according to their musical tastes. The duration of the music can be modulated according to the duration of the medical procedure to follow.
Device: Intervention group IM-IM
The intervention group (IM-IM) will receive a tablet and headphones to listen to music during the toxin injections. Then, during the waiting time, the patient, with or without assistance, will choose the music they wish to listen to, according to their musical tastes. The duration of the music can be modulated according to the duration of the medical procedure to follow.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stress
Time Frame: Baseline
Patient stress, assessed during injection visit no. 1, estimated by the variation in heart rate variability (HRV), measured before and during the botulinum toxin injection session with the LF (sympathic activity)
Baseline
Stress
Time Frame: Baseline

Patient stress, assessed during injection visit no. 1, estimated by the variation in heart rate variability (HRV), measured before and during the botulinum toxin injection session with the HF parameter (parasympatic activity).

The LF/HF ratio is a good reflection of the balance between sympathetic and parasympathetic nervous system activity, which can offer clues to stress regulation, cardiovascular health and physical adaptation. Thus, a low LF/HF ratio may be associated with better recovery, better emotional regulation, and a healthier balance of the autonomic nervous system.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stress
Time Frame: 3 months
Patient stress during injection visit no. 2, estimated by the variation in heart rate variability (HRV), measured before and during the botulinum toxin injection session with the parameter LF/HF.
3 months
Intensity of pain
Time Frame: Baseline and 3 months
The intensity of pain experienced by the patient during the botulinum toxin injection session, during visits to injections n°1 and n°2, measured by a simple numerical scale (ENS) ranging from 0 ("no pain") to 10 ("the worst pain imaginable") immediately after the end of the session.
Baseline and 3 months
Variation of anxiety
Time Frame: Baseline and 3 months
Measurement of the variation in anxiety measured using the State Trait Anxiety Inventory-form Y Etat (STAI-Y1) self-questionnaire, during injection visits n°1 and n°2, before and after botulinum toxin injections. The STAI-Y1 questionnaire consists of 20 questions, measured on a Likert scale ranging from 1-" Not at all" to 4-"Very much so".
Baseline and 3 months
Measurement of perception of session time
Time Frame: Baseline and 3 months
Measurement of perception of session time in relation to actual injection time at injection visits n°1 and n°2. Declarative data collected at the end of the session during the various visits.
Baseline and 3 months
Patient satisfaction with the procedure
Time Frame: Baseline and 3 months
Patient satisfaction with the procedure assessed using a Visual Analogue Scale (VAS) ranging from 0 - "no satisfaction" to 10 - "highest satisfaction" measured after the injections, during injection visits n°1 and n°2.
Baseline and 3 months
Quality of the conditions under which botulinum toxin injections
Time Frame: Baseline and 3 months
The quality of the conditions under which botulinum toxin injections were performed, as assessed by the doctor immediately after the end of the session for injections n°1 and n°2 [using a simple numerical scale (ENS) ranging from 0 ("extremely poor conditions") to 10 ("extremely good conditions")].
Baseline and 3 months

Collaborators and Investigators

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

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Marina BADIN, University Hospital, Clermont-Ferrand

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

Helpful Links

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 (Actual)

April 25, 2025

Primary Completion (Estimated)

October 30, 2027

Study Completion (Estimated)

October 30, 2027

Study Registration Dates

First Submitted

March 27, 2025

First Submitted That Met QC Criteria

April 3, 2025

First Posted (Actual)

April 9, 2025

Study Record Updates

Last Update Posted (Actual)

May 23, 2025

Last Update Submitted That Met QC Criteria

May 22, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RBHP 2024 BADIN
  • 2024-A02840-47 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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