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

NCT05214313 | Terminated

• 1 other identifier: RECHMPL20_0672
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Dystonia; Parkinson Disease; Essential Tremor

Keywords

Music therapy; Abnormal movements; Quality of life; Functional neurosurgery

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Secondary Outcomes (3)

• 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).

• 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).

Study Arms (2)

"Music therapy Intervention" group (G1)

EXPERIMENTAL

Patients in the "Music therapy intervention" group will also perform the 1st session of the program during the inclusion visit (V0). The patients will benefit from fourteen 1-hour music therapy sessions (15 min of reception, installation and debriefing at the end of the session and 45 min of program). The 14 individual sessions will be spread over three months at the rate of 2 weekly sessions the first month then a single weekly session the following month and finally 2 monthly sessions the last month. Patients will be assessed at inclusion, then the first month (V1) and at the end of the intervention (V2).

Behavioral: Music Therapy

" Control " group (G2)

NO INTERVENTION

The patients in this group will benefit from the usual care corresponding to a quarterly medical examination. The patients will be assessed on the day of inclusion (V0) and then during the routine three-month medical examination (V2). At the end of the study, these patients will be able to benefit from the same music therapy program, offered under the same operating conditions.

Interventions

Music Therapy BEHAVIORAL

The standardised music therapy protocol of 45 minutes will include at each session : * 10 min of musical listening in a soothing environment (relaxation chair and reduced and coloured lighting) in sensory isolation (with headphones) and aimed at relaxation as a preamble to the active phase of the protocol * Active phase: (25 min) * 5 min of receptive music therapy linked to a given emotion, different at each session (joy, sadness, anger and fear) aimed at emotional management (feeling and distancing), * 20 minutes of active music therapy with instrumental and vocal improvisation that solicits the body physiologically, * 10 minutes of musical listening in sensory isolation for a state of rest. The entire protocol is carried out with the permanent perception of heartbeats set to a physiological frequency of 50 to 100 BPM.

"Music therapy Intervention" group (G1)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Unité Pathologies Cérébrales Résistantes (UPCR) - Département de Neurochirurgie - Gui de Chauliac

Montpellier, 34295, France

Location

Related Publications (5)

• Sihvonen AJ, Sarkamo T, Leo V, Tervaniemi M, Altenmuller E, Soinila S. Music-based interventions in neurological rehabilitation. Lancet Neurol. 2017 Aug;16(8):648-660. doi: 10.1016/S1474-4422(17)30168-0. Epub 2017 Jun 26.

  PMID: 28663005 BACKGROUND

• Coubes P, Roubertie A, Vayssiere N, Hemm S, Echenne B. Treatment of DYT1-generalised dystonia by stimulation of the internal globus pallidus. Lancet. 2000 Jun 24;355(9222):2220-1. doi: 10.1016/S0140-6736(00)02410-7.

  PMID: 10881900 BACKGROUND

• Ribeiro MKA, Alcantara-Silva TRM, Oliveira JCM, Paula TC, Dutra JBR, Pedrino GR, Simoes K, Sousa RB, Rebelo ACS. Music therapy intervention in cardiac autonomic modulation, anxiety, and depression in mothers of preterms: randomized controlled trial. BMC Psychol. 2018 Dec 13;6(1):57. doi: 10.1186/s40359-018-0271-y.

  PMID: 30545420 BACKGROUND

• Hole J, Hirsch M, Ball E, Meads C. Music as an aid for postoperative recovery in adults: a systematic review and meta-analysis. Lancet. 2015 Oct 24;386(10004):1659-71. doi: 10.1016/S0140-6736(15)60169-6. Epub 2015 Aug 12.

  PMID: 26277246 BACKGROUND

• Lord VM, Hume VJ, Kelly JL, Cave P, Silver J, Waldman M, White C, Smith C, Tanner R, Sanchez M, Man WD, Polkey MI, Hopkinson NS. Singing classes for chronic obstructive pulmonary disease: a randomized controlled trial. BMC Pulm Med. 2012 Nov 13;12:69. doi: 10.1186/1471-2466-12-69.

  PMID: 23145504 BACKGROUND

MeSH Terms

Conditions

Dystonia; Parkinson Disease; Essential Tremor; Dyskinesias

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Philippe COUBES

  Montpellier University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: January 28, 2022
• Study Start: March 3, 2022
• Primary Completion: September 14, 2023
• Study Completion: September 14, 2023
• Last Updated: February 2, 2024

Record last verified: 2024-02

Locations

FR (1)