跳至主要内容
临床试验/NCT05214313
NCT05214313终止不适用

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, Montpellier1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2022年3月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
21
试验地点
1
主要终点
Change of total score of Quality of life assessment (MOS SF-36) baseline at 1 month and 3 months

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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)

研究组 & 干预措施

"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).

干预措施: Music Therapy (Behavioral)

" 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.

结局指标

主要结局

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

时间窗: 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.

次要结局

  • 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).)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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