Music Listening in Radiotherapy Treatment

NCT03538223 | Completed

• 1 other identifier: 2179 CE
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

Music listening; Radiotherapy; Breast cancer; Psychological rehabilitation

Outcome Measures

Primary Outcomes (1)

• Anxiety reduction

  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.

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

Secondary Outcomes (3)

• Anxiety reduction

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

• Stress reduction

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

• Stress reduction

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

Study Arms (3)

Radioterapy+"Melomics-Health" Listening

EXPERIMENTAL

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.

Other: Music Listening; Radiation: Radiotherapy

Radiotherapy+Individualized Listening

EXPERIMENTAL

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.

Other: Music Listening; Radiation: Radiotherapy

Radiotherapy+No Music Listening

OTHER

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

Radiation: Radiotherapy

Interventions

Music Listening OTHER

Participants will undergo two different types of music before radiotherapy sessions

Radioterapy+"Melomics-Health" Listening; Radiotherapy+Individualized Listening

Radiotherapy RADIATION

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

Radioterapy+"Melomics-Health" Listening; Radiotherapy+Individualized Listening; Radiotherapy+No Music Listening

Eligibility Criteria

• Gender Eligibility Details: Women with breast cancer
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead
• University of Pavia: collaborator

Study Sites (1)

Istituti Clinici Scientifici Maugeri SpA

Pavia, Lombardy, 27100, Italy

Location

Related Publications (9)

• Bradt J, Dileo C, Magill L, Teague A. Music interventions for improving psychological and physical outcomes in cancer patients. Cochrane Database Syst Rev. 2016 Aug 15;(8):CD006911. doi: 10.1002/14651858.CD006911.pub3.

  PMID: 27524661 BACKGROUND

• Bradt J, Dileo C, Shim M. Music interventions for preoperative anxiety. Cochrane Database Syst Rev. 2013 Jun 6;2013(6):CD006908. doi: 10.1002/14651858.CD006908.pub2.

  PMID: 23740695 BACKGROUND

• Chen LC, Wang TF, Shih YN, Wu LJ. Fifteen-minute music intervention reduces pre-radiotherapy anxiety in oncology patients. Eur J Oncol Nurs. 2013 Aug;17(4):436-41. doi: 10.1016/j.ejon.2012.11.002. Epub 2012 Dec 4.

  PMID: 23218591 BACKGROUND

• Clark M, Isaacks-Downton G, Wells N, Redlin-Frazier S, Eck C, Hepworth JT, Chakravarthy B. Use of preferred music to reduce emotional distress and symptom activity during radiation therapy. J Music Ther. 2006 Fall;43(3):247-65. doi: 10.1093/jmt/43.3.247.

  PMID: 17037953 BACKGROUND

• Morasso G, Costantini M, Baracco G, Borreani C, Capelli M. Assessing psychological distress in cancer patients: validation of a self-administered questionnaire. Oncology. 1996 Jul-Aug;53(4):295-302. doi: 10.1159/000227576.

  PMID: 8692533 BACKGROUND

• O'Callaghan C, Sproston M, Wilkinson K, Willis D, Milner A, Grocke D, Wheeler G. Effect of self-selected music on adults' anxiety and subjective experiences during initial radiotherapy treatment: a randomised controlled trial and qualitative research. J Med Imaging Radiat Oncol. 2012 Aug;56(4):473-7. doi: 10.1111/j.1754-9485.2012.02395.x. Epub 2012 May 28.

  PMID: 22883658 BACKGROUND

• Raglio A, Vico F. Music and Technology: The Curative Algorithm. Front Psychol. 2017 Nov 24;8:2055. doi: 10.3389/fpsyg.2017.02055. eCollection 2017. No abstract available.

  PMID: 29250008 BACKGROUND

• Rossetti A, Chadha M, Torres BN, Lee JK, Hylton D, Loewy JV, Harrison LB. The Impact of Music Therapy on Anxiety in Cancer Patients Undergoing Simulation for Radiation Therapy. Int J Radiat Oncol Biol Phys. 2017 Sep 1;99(1):103-110. doi: 10.1016/j.ijrobp.2017.05.003. Epub 2017 May 8.

  PMID: 28816136 BACKGROUND

• Raglio A, Oddone E, Meaglia I, Monti MC, Gnesi M, Gontero G, Imbriani C, Ivaldi GB. Conventional and Algorithmic Music Listening before Radiotherapy Treatment: A Randomized Controlled Pilot Study. Brain Sci. 2021 Dec 8;11(12):1618. doi: 10.3390/brainsci11121618.

  PMID: 34942921 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Alfredo Raglio, PhD

  Istituti Clinici Scientifici Maugeri SpA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 29, 2018
• Study Start: March 5, 2018
• Primary Completion: June 30, 2020
• Study Completion: September 30, 2020
• Last Updated: January 20, 2022

Record last verified: 2022-01

Locations

IT (1)