Effects of Recorded Music in Heart Failure Patients
EMSC
A Randomized Controlled Trial of Listen Recorded Music for Hearth Failure Patients
1 other identifier
interventional
150
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2015
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedFirst Posted
Study publicly available on registry
March 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMarch 27, 2017
March 1, 2017
8 months
February 17, 2015
March 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in heart failure specific quality of life (Minnesota Living with Heart Failure Questionnaire)
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 Outcomes (9)
Use of emergency services
1st, 2nd, 3th, 6th month
Generic quality of life (measured with the Short Form -12.)
Baseline, 1st 2nd, 3th, 6th month
Self-care (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)
Baseline, 1st 2nd, 3th, 6th month
Sleep quality (Pittsburgh Sleep Quality Index)
Baseline, 1st 2nd, 3th, 6th month
- +4 more secondary outcomes
Study Arms (2)
MUSIC
EXPERIMENTALIn addition to the standard care, heart failure patients assigned to the music group will listen recorded classical music.
CONTROL
NO INTERVENTIONHeart 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.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- deafness ;
- severe neurological disorder (Parkinson, multiple sclerosis, Alzheimer's disease;
- severe psychiatric disorder;
- frank dementia,
- reduced level of consciousness.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Francesco Burrai
Bologna, Bologna, 40124, Italy
Related Publications (7)
Bernardi L, Porta C, Casucci G, Balsamo R, Bernardi NF, Fogari R, Sleight P. Dynamic interactions between musical, cardiovascular, and cerebral rhythms in humans. Circulation. 2009 Jun 30;119(25):3171-80. doi: 10.1161/circulationaha.108.806174.
PMID: 19569263RESULTChanda ML, Levitin DJ. The neurochemistry of music. Trends Cogn Sci. 2013 Apr;17(4):179-93. doi: 10.1016/j.tics.2013.02.007.
PMID: 23541122RESULTFancourt D, Ockelford A, Belai A. The psychoneuroimmunological effects of music: a systematic review and a new model. Brain Behav Immun. 2014 Feb;36:15-26. doi: 10.1016/j.bbi.2013.10.014. Epub 2013 Oct 21.
PMID: 24157429RESULTHanser SB. Music therapy in cardiac health care: current issues in research. Cardiol Rev. 2014 Jan-Feb;22(1):37-42. doi: 10.1097/CRD.0b013e318291c5fc.
PMID: 23535529RESULTMandel SE, Hanser SB, Secic M, Davis BA. Effects of music therapy on health-related outcomes in cardiac rehabilitation: a randomized controlled trial. J Music Ther. 2007 Fall;44(3):176-97. doi: 10.1093/jmt/44.3.176.
PMID: 17645384RESULTTrappe HJ. The effects of music on the cardiovascular system and cardiovascular health. Heart. 2010 Dec;96(23):1868-71. doi: 10.1136/hrt.2010.209858.
PMID: 21062776RESULTBurrai F, Hasan W, Fancourt D, Luppi M, Di Somma S. A Randomized Controlled Trial of Listening to Recorded Music for Heart Failure Patients: Study Protocol. Holist Nurs Pract. 2016 Mar-Apr;30(2):102-15. doi: 10.1097/HNP.0000000000000135.
PMID: 26871248DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria Cristina Pirazzini, MSN
AUSL Bologna
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
February 17, 2015
First Posted
March 20, 2015
Study Start
March 1, 2015
Primary Completion
November 1, 2015
Study Completion
December 1, 2015
Last Updated
March 27, 2017
Record last verified: 2017-03