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临床试验/NCT03538223
NCT03538223已完成不适用

Music Listening to Reduce Anxiety and Stress in Patients Undergoing Radiotherapy

Istituti Clinici Scientifici Maugeri SpA2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年3月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Anxiety reduction

研究概览

简要总结

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.

详细描述

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.

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

性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Anxiety reduction

时间窗: Baseline (T0) vs 2 weeks (T1, i.e. end of radiotherapy treatment)

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.

次要结局

  • Anxiety reduction(Baseline (T0) vs 4 weeks (T2, two weeks after the end of radiotherapy treatment))
  • Stress reduction(Baseline (T0) vs 4 weeks (T2, two weeks after the end of radiotherapy treatment))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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