Effects of Recorded Music in Heart Failure Patients (EMSC)

March 24, 2017 updated by: CARLO DESCOVICH, Azienda Usl di Bologna

A Randomized Controlled Trial of Listen Recorded Music for Hearth Failure Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40124
        • Francesco Burrai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • a confirmed diagnosis of heart failure according to the guidelines specified by the European Society of Cardiology ;
  • NYHA functional classification I to III, including patients with preserved ejection fraction (HFPEF) and with a reduced ejection fraction (HFREF);
  • the presence of a formal or informal caregiver;
  • signed informed consent.

Exclusion Criteria:

  • deafness ;
  • severe neurological disorder (Parkinson, multiple sclerosis, Alzheimer's disease;
  • severe psychiatric disorder;
  • frank dementia,
  • reduced level of consciousness.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MUSIC
In addition to the standard care, heart failure patients assigned to the music group will listen recorded classical music.
Other: MUSIC
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).
No Intervention: CONTROL
Heart Failure patients assigned to the control group will receive standard care only. The standard care will consist in nursing and medical counselling, self-care education and medication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in heart failure specific quality of life (Minnesota Living with Heart Failure Questionnaire)
Time Frame: Baseline, 1st 2nd, 3th, 6th month
The heart failure specific quality of life will be measured with the Minnesota Living with Heart Failure Questionnaire.
Baseline, 1st 2nd, 3th, 6th month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of emergency services
Time Frame: 1st, 2nd, 3th, 6th month
1st, 2nd, 3th, 6th month
Generic quality of life (measured with the Short Form -12.)
Time Frame: Baseline, 1st 2nd, 3th, 6th month
The generic quality of life will be measured with the Short Form -12.
Baseline, 1st 2nd, 3th, 6th month
Self-care (Self-Care of Heart Failure Index version 6.2)
Time Frame: Baseline, 1st 2nd, 3th, 6th month
Patient's self-care will be measured with the Self-Care of Heart Failure Index version 6.2
Baseline, 1st 2nd, 3th, 6th month
Somatic perception of heart failure symptoms (Heart Failure Somatic Perception Scale)
Time Frame: Baseline, 1st 2nd, 3th, 6th month
Somatic perception of heart failure symptoms. They will be evaluated with the Heart Failure Somatic Perception Scale
Baseline, 1st 2nd, 3th, 6th month
Sleep quality (Pittsburgh Sleep Quality Index)
Time Frame: Baseline, 1st 2nd, 3th, 6th month
Sleep quality. Sleep quality will be measured with the Pittsburgh Sleep Quality Index
Baseline, 1st 2nd, 3th, 6th month
Anxiety and depression (Hospital Anxiety and Depression Scale)
Time Frame: Baseline, 1st 2nd, 3th, 6th month
Anxiety and depression will be measured with the
Baseline, 1st 2nd, 3th, 6th month
Cognition (Montreal Cognitive Assessment)
Time Frame: Baseline, 1st 2nd, 3th, 6th month
Cognition will be measured by Montreal Cognitive Assessment
Baseline, 1st 2nd, 3th, 6th month
Hospitalization
Time Frame: 1st, 2nd, 3th, 6th month
1st, 2nd, 3th, 6th month
Mortality
Time Frame: 1st, 2nd, 3th, 6th month
1st, 2nd, 3th, 6th month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Usl di Bologna

Investigators

  • Principal Investigator: Maria Cristina Pirazzini, MSN, AUSL Bologna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

February 17, 2015

First Submitted That Met QC Criteria

March 17, 2015

First Posted (Estimate)

March 20, 2015

Study Record Updates

Last Update Posted (Actual)

March 27, 2017

Last Update Submitted That Met QC Criteria

March 24, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE 14123

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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