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Clinical Trials/NCT05214313
NCT05214313TerminatedNot Applicable

Impact of a Standardized Music Therapy Protocol on the Quality of Life of Patients With Abnormal Movements Treated With Continuous Electrical Neuromodulation (Music-QOL)

University Hospital, Montpellier2 sites in 1 country21 target enrollmentStarted: March 3, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
21
Locations
2
Primary Endpoint
Change of total score of Quality of life assessment (MOS SF-36) baseline at 1 month and 3 months

Study Overview

Brief Summary

The study of the impact of music on emotional, motor and cognitive aspects remains recent. Music therapy has experienced a major boom over the last half century thanks to neuroradiological techniques for investigating the brain, and in particular in vivo functional MRI. Brain imaging has also made it possible to highlight and analyse certain activations of the networks concerned during the passive listening of music (receptive music therapy) but also during the playing of a musical instrument and/or the use of the voice (active music therapy). The accumulated data in music neurophysiology is now considerable [1]. Music therapy has thus been associated with motor rehabilitation in the case of acquired (stroke) and/or degenerative (Parkinson's disease) pathologies and has also been proposed as a means of pain relief. However, although proposed in the middle of the 20th century as a potentially therapeutic tool, music therapy has not managed to prove sufficiently effective to be validated in medicine. One of the limitations remains the intervention of numerous subjective factors, notably in the establishment of "protocols" and the absence of standardisation in their very structures.

Each year, the "Resistant Brain Pathology" unit of the Department of Neurosurgery takes care of more than a hundred patients who have benefited from treatment with Continuous Electrical Neuromodulation (CEN) in order to respond to a motor symptomatology that is resistant to the usual treatments. The benefits of DBS in the management of abnormal movements have been demonstrated [2]. However, this symptomatic treatment does not exclude a worsening of the underlying pathology over time, thereby increasing latent anxiety and promoting the fragility of otherwise severely disabled patients. The management of chronic diseases requires the expertise of a multidisciplinary team so that each aspect contributing to the quality of life of patients can be assessed and supported as best as possible.

In order to improve the quality of life of our patients, a music therapy unit has been established within the multidisciplinary neurosurgery department for two years now. The clinical music therapist attached to the unit has a dedicated room, offering a sensory environment conducive to relaxation and including all the necessary comfort. A standardised protocol for the conduct of the sessions, the organisation and choice of music in direct relation to the different emotions explored on the basis of the permanent perception of heartbeats was developed on the basis of the Webb & all study [3]. When a patient is immersed in a sound bath, identical to that perceived in utero, it would seem that this potentiates the benefits expected from music therapy sessions [3].

Our approach, although empirical, shows a decrease in anxiety and an increase in well-being in about fifty patients. Our observations support those highlighted in the literature in other pathologies [4] and encourage the use of this approach as a preamble to more specific explorations, in particular the catalysis of certain motor behaviours.

This project is therefore in line with this approach and continuity.

The investigators thus hypothesize that participation in a standardized music therapy protocol (active, receptive and psychomusical relaxation) against a background of regular heartbeats improves the quality of life of the operated patients by acting in particular on a reduction of anxiety and depressive symptoms.

To our knowledge, music therapy has never been proposed in a standardised way to patients with multiple disabilities, operated on and cared for over the long term in a functional neurosurgery department. This approach remains non-invasive and attractive in an often anxiety-provoking hospital context.

Detailed Description

Methodology:

This is a prospective, controlled, randomised, open-label, single-centre, two-arm, parallel, 1:1 ratio, non-drug therapeutic interventional study with three months of follow-up (Category 2)

The analysis of the primary and secondary endpoints will be conducted on an intention-to-treat (ITT) basis: each patient will be analysed in his or her randomisation arm once the patient has been assessed at inclusion and has received at least one assessment of the primary endpoint.

Initial comparability of groups A description of each group will be made by giving the frequencies of the different categories for the qualitative variables. As the distributions of the quantitative variables are not always Gaussian, the description of these variables will be done using the mean and the standard deviation but also the median and the minimum and maximum values. In case of non-comparability of the groups on one of the confounding factors, an adjustment or a stratification (in case of interaction) will be considered.

Analysis of primary endpoint The absolute change in the SF36 total score between the 2 assessments (T0 and T3 months) will be compared between the two groups using a Student's t test if the distribution is Gaussian or by a non-parametric test otherwise (Mann-Witney).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adult subjects (≥ 18 years)
  • Meets eligibility criteria: treated with CEN and medically stabilised

Exclusion Criteria

  • Not be available for 3 consecutive months
  • Not be able to speak and understand the French language
  • Severe disability that would prohibit musical practice according to the investigator (such as tetraparesis, anarthria...)
  • Lack of informed consent
  • Foreseeable absence from at least 30% of the sessions
  • Pregnancy in progress or planned during the study, pregnant or breastfeeding
  • Adult protected by law or patient under guardianship or curatorship
  • Not residing in Occitania
  • Not covered by a social security scheme
  • Participation in another ongoing research project
  • Complementary therapeutic treatment such as 3rd wave Cognitive Behavioural Therapy (mindfulness or relaxation type)

Outcomes

Primary Outcomes

Change of total score of Quality of life assessment (MOS SF-36) baseline at 1 month and 3 months

Time Frame: The evaluations will take place at three times : at patient inclusion (V0), at 1 month (V1) and at 3 months from the intervention (V2).

It is a generic scale, it can be administered to subjects with a wide range of health problems, or even to healthy subjects in the general population.The scale can be administered as a self-administered questionnaire or as a hetero-questionnaire and requires only 5 to 10 minutes. There are 11 questions in the SF-36, with 36 items in total. Its assess 8 dimensions divided into two: a physical component and a mental component. The ninth dimension consists of a single question: Evolution of perceived health. The patient assesses his or her current health status by comparing it to his or her health status one year earlier. This item provides an indicator of the change in the patient's perceived health status. A high score corresponds to a better quality of life. The primary endpoint is the difference in total score on the SF-36 at the end of the programme (at 3 months) between the music therapy intervention group and the control group.

Secondary Outcomes

  • Hospital Anxiety Depression-Scale (HAD-S)(The evaluations will take place at three times : at baseline (patient inclusion (V0)), at 1 month (V1) and at 3 months from the intervention (V2).)
  • Weel-being Scale (EV.I.BE: Echelle d'évaluation instantanée du Bien-Etre)(The evaluations will take place at three times : at baseline (patient inclusion (V0)), at 1 month (V1) and at 3 months from the intervention (V2).)
  • Variation of score in the Quality of life assessment (MOS SF-36)(At patient inclusion (V0), at 1 month (V1) and at 3 months from the intervention (V2).)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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