Behaviors and Mental Disorders

All Conditions

Anxiety Disorders

* Music listening (According to the patient's wishes),
* Hypnosis sessions with the hypnotherapist during the 1st, 2nd and 3rd radiotherapy session,
* Self-hypnosis during the 4th and 5th radiotherapy session,
* Questionnaires (STAI-Y and QLQ-C30) and numerical scales (anxiety and pain) will be completed by patients during radiotherapy consultations.

Relaxation with music listening and medical hypnosis during radiotherapy treatment:

* Music listening (According to the patient's wishes),
* Questionnaires (STAI-Y and QLQ-C30) and numerical scales (anxiety and pain) will be completed by patients during radiotherapy consultations.

Relaxation with music listening during radiotherapy treatment:

Anne DUCASSOU

This phase II, randomized, non-comparative and monocentric study aims to evaluate the interest of medical hypnosis in the management of anxiety in patients who are moderately anxious, anxious or very anxious during their radiotherapy treatment.

45 patients will be randomized into the following arms:

* Arm A (standard): relaxation with music listening during radiotherapy treatment
* Arm B (experimental): relaxation with music listening and hypnosis during radiotherapy treatment

For the study each patient will be followed during 2 months.

Interest of Medical Hypnosis in Anxious Patients Treated by Radiotherapy

Phase II Study Aiming to Evaluate the Interest of Medical Hypnosis in Anxious Patients Treated by Radiotherapy

Anxiety will be assessed using the STAI-Y questionnaire (Spielberger State-Trait Anxiety Inventory - State Anxiety form).

Changes in quality of life from baseline will be assessed in the classroom according to the recommendations of the literature (Osoba, JCO).

Institut Claudius Regaud

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Pain

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Hypnotics and Sedatives

Patients will be randomized to listen to music with iPod that has preferred music selections that patients can choose.

Patients will be randomized to listen to hypnotic music with relaxation breathing narrative.

The preferred music listening group will receive 15 minute patient-preferred music listening selection intervention in the Prep Room and unlimited music listening selection intervention in the PACU once cognitively ready until discharge criteria met.

Preferred music listening

The relaxation breathing group will receive the relaxation and breathing instructions over soft monotone hypnotic music in the PreOp unit before surgery and then in the PACU once cognitively ready to listen to the hypnotic music until discharge criteria met.

Relaxation breathing narrative over hypnotic music listening

Myrna E Mamaril, DNP

A randomized comparison clinical trial will be conducted in laparoscopic radical prostatectomy patients in the Weinberg PACU at the Johns Hopkins Hospital. 50 patients will be recruited and randomly assigned by a table of random numbers to either the music listening group (n=35) or the relaxation breathing group (n=35).

Hypothesis:

Laparoscopic radical prostatectomy patients who experience music listening will report decreased anxiety scores and improved pain control scores compared with patients listening to relaxation and breathing.

Null Hypothesis:

There will be no difference in reported anxiety scores and pain control scores between laparoscopic radical prostatectomy patients listening to music versus listening to relaxation and breathing instructions.

Music listening participants who meet inclusion criteria will be consented in the PreOp Unit and asked to complete the Spielberg State Trait Anxiety Inventory (STAI) questionnaire. Patient vital signs will be taken and patient will be invited to listen to music study iPod for 15 minutes prior to changing into a hospital gown.

Intervention:

The music listening group will receive the standard care and a 15 minute patient-preferred music listening selection intervention in the Prep Room and unlimited music listening selection intervention in the PACU once cognitively ready until discharge criteria met. The relaxation breathing group will receive the relaxation and breathing instructions over soft monotone music in the PACU once cognitively ready until discharge criteria met.

Results:

The experimental music listening group will reveal statistically significant decrease postanesthesia anxiety and pain, while lowering the blood pressure, heart rate and amount of opioids after laparoscopic radical prostatectomy surgery compared to the control group.

Conclusion:

The findings of the music listening intervention will provide further evidence to support the practice of music listening to decrease postanesthesia anxiety and pain, while lowering the blood pressure, heart rate and amount of opioids after laparoscopic radical prostatectomy surgery.

Randomized comparative study comparing two types of music listening interventions of preferred music with Spotify compared to hypnotic music with relaxation and breathing narrative

PI will be working collaboratively with primary nurse. Both PI and primary nurse will maintain nursing personal protective equipment (PPE) standard of care required for the PreOp and PACU units. Prep and PACU nurses will be blinded to type of intervention

men between the ages of 45 to 80 years and who are scheduled for laparoscopic radical prostatectomy surgery will be recruited.

Music Listening as a Postanesthesia Care Unit (PACU) Nursing Intervention

Music Listening as a Postanesthesia Care Unit (PACU) Nursing Intervention After Laparoscopic Radical Prostatectomy

The Spielberg STAI Questionnaire has a score range of 20-80, with higher scores indicating greater anxiety.

Pain will be assessed on a 0-10 scale with higher scores signifying more pain.

Johns Hopkins University

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

The musical content is composed by an algorithm (named "Melomics-Health") with the purpose of acting psychologically and physiologically on the person: the music follows a constant, melodic trend with a reduced musical density; time is unchanged and there are no significant dynamic and tonal variations. Patients will undergo to music listening for 15 minutes (5 tracks lasting 3 minutes each) before radiotherapy session. Appropriate earphones will be used in order to focus their attention on the musical-sound component and to isolate themselves from the external context.

The musical content is based on the patient's preferred music (chosen by patients with the support of the music therapist) with the purpose of acting psychologically and physiologically on the person. Patients will undergo to music listening for 15 minutes before radiotherapy session. Appropriate earphones will be used in order to focus their attention on the musical-sound component and to isolate themselves from the external context.

Patients will undergo the standard treatment (radiotherapy) without music support.

Participants will undergo two different types of music before radiotherapy sessions

Music Listening

All participants will undergo radiotherapy according to breast cancer post surgery protocol

Radiotherapy

Alfredo Raglio, PhD

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.

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).

Music Listening in Radiotherapy Treatment

Music Listening to Reduce Anxiety and Stress in Patients Undergoing Radiotherapy

Difference in State-Trait Anxiety Inventory (STAI) score. There are 2 subscales within this measure: 1) the State Anxiety Scale (S-Anxiety) evaluating the current state of anxiety; 2) the Trait Anxiety Scale (T-Anxiety) evaluating relatively stable aspects of "anxiety proneness". Range of scores for each subtest is 20-80, the higher score indicating greater anxiety.

Difference in Psychological Distress Inventory (PDI) score. Score range is from 13 (low distress level) to 65 (high distress level).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Interest of Medical Hypnosis in Anxious Patients Treated by Radiotherapy	NCT04513444	Solid Tumor	Relaxation with... Relaxation with...	18 Years -	Institut Claudius Regaud
Interest of Medical Hypnosis in Anxious Patients Treated by Radiotherapy	NCT04513444	Solid Tumor	Relaxation with... Relaxation with...	18 Years -	Institut Claudius Regaud
Music Listening as a Postanesthesia Care Unit (PACU) Nursing Intervention	NCT04596917	Prostate Cancer	Preferred music... Relaxation brea...	45 Years - 80 Years	Johns Hopkins University
Music Listening in Radiotherapy Treatment	NCT03538223	Breast Cancer	Music Listening Radiotherapy	-	Istituti Clinici Scientifici Maugeri SpA

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