Music Listening to Reduce Anxiety and Stress in Patients Undergoing Radiotherapy
Trial ID: NCT03538223
Status: COMPLETED
Study type: INTERVENTIONAL
Phase: NA
Start date: 2018-03-05
Completion date: 2020-09-30
Sponsor: Istituti Clinici Scientifici Maugeri SpA
Collaborators: University of Pavia
Conditions: Breast Cancer
Interventions: Music Listening; Radiotherapy
Locations: Istituti Clinici Scientifici Maugeri SpA
Countries: Italy
Enrollment: 60
Age range: None - None
Sex: FEMALE

Summary:
Music and music therapy are now widely used as non-pharmacological intervention techniques in different clinical and therapeutic settings.

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 with the psycho-somatic imbalances to which the person is subjected.

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".

The objective of the study is to verify whether the perception of anxiety and stress in cancer patients undergoing Radiotherapy is influenced by music listening ("Melomics-Health" music vs listening to favorite music). Sixty breast cancer surgical patients, candidates for post-operative radiotherapy with a healing purpose. Patients who will undergo Radiation therapy for the first time in their lives will be included.

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) "Melomics-Health" music listening group (n = 20); b) favorite music listening group (n = 20); c) no-music control group (n = 20). Music groups will undergo 15 minutes music listening immediately before the simulation and the first 5 sessions of radiotherapy.

Patients will be subjected to a psychological assessment focused on anxiety (State-Trait Anxiety Inventory) and distress (Psychological Distress Inventory) dimensions 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). A specific questionnaire will also be submitted to the patients included in music groups. 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.

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 analysis of variance models.

Eligibility criteria:
Inclusion Criteria:

* patients who will undergo Radiation therapy for the first time in their lives
* patients who are candidates for hypofractionated partial breast irradiation with a duration of at least 10 sessions
* patients who signed the informed consent

Exclusion Criteria:

* patients with associated diseases that preclude the understanding of the study contents (eg patients with established psychiatric disorders and / or with significant cognitive deficits)
* patients with significant hearing loss
* patients already previously subjected to music therapy or therapy based on music listening
* patients with musical skills (musical training or musical practice\> 3 years).
* patients who are candidates for hypofractionated partial breast irradiation with a duration equal to or less than 10 sessions

Outcomes:
Anxiety reduction