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Trials
Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

Effect of a musical intervention on tolerance and efficacy of non-invasive ventilation in the ICU: study protocol for a randomized controlled trial (MUSique pour l’Insuffisance Respiratoire Aigue - Mus-IRA)

Authors: Jonathan Messika, David Hajage, Nataly Panneckoucke, Serge Villard, Yolaine Martin, Emilie Renard, Annie Blivet, Jean Reignier, Natacha Maquigneau, Annabelle Stoclin, Christelle Puechberty, Stéphane Guétin, Aline Dechanet, Amandine Fauquembergue, Stéphane Gaudry, Didier Dreyfuss, Jean-Damien Ricard

Published in: Trials | Issue 1/2016

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Abstract

Background

Non-invasive ventilation (NIV) tolerance is a key factor of NIV success. Hence, numerous sedative pharmacological or non-pharmacological strategies have been assessed to improve NIV tolerance. Music therapy in various health care settings has shown beneficial effects. In invasively ventilated critical care patients, encouraging results of music therapy on physiological parameters, anxiety, and agitation have been reported. We hypothesize that a musical intervention improves NIV tolerance in comparison to conventional care. We therefore question the potential benefit of a receptive music session administered to patients by trained caregivers (“musical intervention”) to enhance acceptance and tolerance of NIV.

Methods/design

We conduct a prospective, three-center, open-label, three-arm randomized trial involving patients in the intensive care unit (ICU) who require NIV, as assessed by the treating physician. Participants are allocated to a “musical intervention” arm (“musical intervention” applied during all NIV sessions), to a “sensory deprivation” arm (sight and hearing isolation during all NIV sessions), or to the control group. The primary endpoint is the change in respiratory comfort (measured with a digital visual scale) before the initiation and after 30 minutes of the first NIV session. The evaluation of the primary endpoint is performed blindly from the treatment group. Secondary endpoints include changes in respiratory and cardiovascular parameters during NIV sessions, the percentage of patients requiring endotracheal intubation, day-90 anxiety/depression and health-related quality of life, post-trauma stress induced by NIV, and the overall assessment of NIV.
The follow-up for each participant is 90 days. We expect to randomize a total of 99 participants.

Discussion

As music intervention is a simple and easy-to-implement non-pharmacological technique, efficacious in reducing anxiety in critically ill patients, it appeared logical to assess its efficacy in NIV, one of the most stressful techniques used in the ICU. Patient centeredness was crucial in choosing the outcomes assessed.

Trial registration

ClinicalTrials.gov: NCT02265458. Registered on 25 August 2014.
Appendix
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Metadata
Title
Effect of a musical intervention on tolerance and efficacy of non-invasive ventilation in the ICU: study protocol for a randomized controlled trial (MUSique pour l’Insuffisance Respiratoire Aigue - Mus-IRA)
Authors
Jonathan Messika
David Hajage
Nataly Panneckoucke
Serge Villard
Yolaine Martin
Emilie Renard
Annie Blivet
Jean Reignier
Natacha Maquigneau
Annabelle Stoclin
Christelle Puechberty
Stéphane Guétin
Aline Dechanet
Amandine Fauquembergue
Stéphane Gaudry
Didier Dreyfuss
Jean-Damien Ricard
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1574-z

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