Effects of Recorded Music in Heart Failure Patients
Condition: Heart Diseases
MeSH terms: Heart Diseases
Study type: Interventional

Summary: 
      Aims. To describe a new conceptual framework and to test the effectiveness of a recorded
      music listening protocol on symptom burden and quality of life in heart failure patients.
    

Detailed description: 
      Background. Heart failure is an important public health problem. Many heart failure patients
      experience symptoms burden and poor quality of life, even after the improvements in
      pharmacological treatments. Recorded music listening was shown to improve outcomes in
      cardiovascular patients but it was never tested on heart failure patients. Methods. This
      study is a multi-centred single-blind randomized controlled trial that will involve 150
      patients. Eligible patients will have a diagnosis of heart failure, in New York Hearth
      Association functional classification I to III, and will be recruited from seven outpatient
      clinics in Northern Italy. Patients will be randomly allocated in a 1:1 ratio to receive the
      recorded music listening intervention or the standard care for 3 months. Data will be
      collected at baseline and first, second and three month during the intervention, and at six
      month for follow-up. The following variables will be collected from heart failure patients by
      validated outcome measuring instruments for quality of life (primary endpoint), use of
      emergency services, re-hospitalization rates, all-cause mortality,self-care, somatic
      symptoms, quality of sleep ,anxiety and depression, cognitive state. The study has been
      funded by Italian Heart Failure Association in November 2014 with number 01/04. Ethical
      approval was gained in December 22, 2015.

      Discussion. This study will be a trial to examine the effect of recorded music listening on
      heart failure patients and will inform clinical practice and will provide empirical data for
      a new music protocol intervention evidence based. The new framework may be helpful for future
      research focused on music effect in heart failure patients.

      Sample size calculation.The sample size will be based on the primary endpoint of quality of
      life measured with the Minnesota Living with Heart Failure Questionnaire. Considering two
      balanced groups (n1 = n2), a medium effect size (d = 0.5), α error of 5% and power of 80% to
      detect differences between groups, it would be necessary to enrol a total of 128 (n1 = n2 =
      64) patients. A medium effect size d = 0.5 implies a sample different expectation of 10
      points at the Minnesota Living with Heart Failure Questionnaire, in according to study of
      Parati and colleges (Parati, Malfatto et al. 2008). Given the ordinal nature of the variable,
      and assuming a normal distribution of scores, to maintain power to the expected value (80%),
      we should multiply by π / 3 (asymptotic relative efficiency value), obtaining a total of 134
      subjects. Finally, assuming a drop-out of 10% for group (Park, Park et al. 2012), it will
      needed to enrol a total of 150 patients, 75 subjects per group. Data analysis.

      Data from patients will entered into spreadsheet files and checked for data errors
      independently by another researcher. Analyses will conducted using SPSS 19.0 (IBM
      Corporation, Armonk,NY). Descriptive statistics, mean, standard deviation, frequencies,
      median and interquartile ranges will be used to describe scale scores and social-demographic
      and clinical data. All tests will be two-tailed. A probability value <0.05 will be considered
      the minimum level of statistical significance. To test the means differences between groups
      at baseline and at 1st 2nd, 3th month and at 6th month after enrolment, repeated measures
      ANOVA with Bonferroni post-hoc test will be used. If repeated measures ANOVA will show an
      effect of treatment, MANCOVA analysis will be used to verify possible association between the
      outcome and continuous predictor variables. To calculate the correlations between the scores
      of the different questionnaires the correlation coefficient of Pearson or Spearman will used
      with. Fisher's exact test or χ2 test will be used to identify differences in use of emergency
      services, hospitalization and mortality between intervention and control group.
    

Intervention name(s): MUSIC
Intervention type(s): Other
Intervention description(s): In addition to the standard care,patients assigned to the music group will listen recorded classical music. Music will be delivered with a mp3 Player and headphones Music will be listened by the patient in his home.The music play list will be formed by a classical repertoire.During the intervention patients will be recommended to listen to the music for 3 months. Also patients will be asked to listen to the music once or more than once per day, at any time, for a total of 30 minutes per day.Music will be listen at 50-60 decibels below the threshold of 85 db established for listening to portable media devices such as compact disc and MP3 players.Music in this protocol will have a tempo/rhythm in a range of 60-80 beats per minute (bpm).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Music therapy