Introduction: Music and music therapy are now widely used as non-pharmacological intervention techniques in different clinical and therapeutic settings.
Scientific literature includes a large number of studies structured according to scientific criteria and its presence is documented by the existence of numerous systematic reviews about this topic (including Cochrane Reviews). Some of these reviews, together with single studies, concern to the use of music in the hospital setting in different areas as: the pre-surgical and surgical phases, specific oncology interventions and also radiotherapy / chemiotherapy treatments. In these contexts the applicative experiences are generally characterized by two factors: the music therapy technique used that is the use of musical listening rather than active music therapy interventions (interaction between patient and therapist through musical instruments) and the possible effectiveness of music on momentary symptoms as anxiety, stress and pain deriving from illness conditions and / or from particularly invasive medical procedures.
The present study includes the use of musical listening related to the concept of "Music Medicine", a possibility of modifying the psycho-physiological state of the patient through the targeted use of musical pieces respondent to specific parameters and musical structures able to interact in particular conditions (such as illness, surgery, etc) with the psycho-somatic imbalances to which the person is subjected. On the other hand, it has been demonstrated that music can also significantly affect vital parameters and neurochemical processes leading to significant modifications of these aspects.
In particular, in this study, in addition to proposing a traditional listening method, the music used in one of the research arms will be composed of an artificial intelligence called "Melomics-Health" and created in collaboration with the Research Group in Biomimetics of the University of Malaga. This way of composing music gives the possibility to intervene on the design of the music itself, creating the necessary conditions for its use in the therapeutic field. Music can be composed on the basis of specific sound parameters and appropriate musical structures with the aim of achieving the intended therapeutic objective. In this direction, numerous studies have been undertaken whose initial results are really encouraging. One of the advantages of this technology is given by the possibility of forging and shaping the music according to the therapeutic objective, leaving to the artificial intelligence the task to produce it. This perspective represents an absolute innovation and creates considerable potentialities in the use of music listening aimed at the care and health of the individual. The concept above exposed concerning the action of sound and music on the individual together with the use of "Melomics-Health" technology, create the necessary conditions for the fulfillment of the proposed study.
Material and Methods: Sixty breast cancer surgical patients, candidates for post-operative radiotherapy with a healing purpose.
Study design: patients will be recruited in this randomized controlled study with a sequential enrollment and, in the case of inclusion, will be assigned to one of the following 3 groups: a) music listening group (n = 20) (with "Melomics-Health" music) created in relation to the objective of the study; b) favorite music listening group (n = 20) (who will listen to a play-list created with the collaboration of a music therapist; c) a control group (n = 20) to which no musical listening will be proposed. A randomization list, in accordance with a completely randomized parallel group study design, will be generated at the beginning of the study. Within the randomization list, each subject will be uniquely identified by a numerical code that will allow its identification during the entire duration of the study if necessary. Patient identification data will be kept in a separate and properly protected database. The type of intervention expected for this study does not allow its blind conducting for the investigator and for the participant. However, the blindness of psychological and statistical evaluations will be guaranteed in order to reduce the possibility of distortions due to observer or statistical biases.
Assessment: patients will be subjected to a psychological assessment focused on anxiety and distress dimensions correlated to the planned medical procedure and more generally to the clinical condition. At the time of patients enrollment (screening) a clinical / anamnestic assessment will be performed, the inclusion criteria will be verified and appropriate patients will be asked to sign the informed consent. At the baseline (T0), at the end of the treatments (T1) and at the Follow-up (T2, 2 weeks after the fifth session of Radiotherapy) the State-Trait Anxiety Inventory form Y (STAI) and the Psychological Distress Inventory (PDI) will be administered. At T1 phase (conclusion of the treatments) a specific questionnaire will also be submitted to the patients of groups A and B. This questionnaire will allow the music therapist to acquire specific qualitative information regarding the different types of music listening and the responses of the subjects to them.
Procedures: Phase 1. The staff identified by the research team, having verified the presence of inclusion criteria, will consider the patient enrollment and will assign it to one of the treatment arms ("Melomics-Health" listening, individualized listening and absence of music) on the basis of the Principal Investigator indications who manages the randomization list. The patient will be initially explained the motivations and general contents of the study. Only after the patient's effective adherence to the treatment and after the signing of the informed consent, the procedure of the study will be shown the patient according to the assignment group. Patients who adhere to the proposal will be asked to provide some personal information and will subsequently be subjected to the assessments expected by the study. Any failure in obtaining the informed consent or any case of refusal to the request to participate in the study by the enrolled patient, will make it consider as a drop-out patient.
Phase 2. Before the simulation session the psychological scales expected at T0 will be submitted to the patients (STAI of state and of trait and Psychological Distress Inventory - PDI). The treatments will be repeated during the simulation session and for the first five sessions of Radiotherapy. During the last day of treatment (T1, 5th session) and 2 weeks after the conclusion of the treatments (T2) all patients will be evaluated again through the administration of STAI of state and of trait and Psychological Distress Inventory - PDI. During the last day of treatment, a specific musical questionnaire will also be submitted to patients in groups A and B.
Statistics: A statistical analysis plan will be defined in detail before the start of the data analysis phase, taking into account the exploratory nature of the study. In general, descriptive statistics will be produced for all the variables detected. The effectiveness of musical listening in relation to the psychological aspects considered will be evaluated by applying the appropriate models of analysis of variance. All randomized patients for whom at least one available follow-up will be included in the main statistical analyzes (Intention-To-Treat population, with Last Observation Carried Forward); secondary analyzes will be carried out on the subgroup consisting only of patients who have completed the entire follow-up (Per-Protocol population).
