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Trials. 2016 Sep 13;17(1):450. doi: 10.1186/s13063-016-1574-z.

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).

Author information

1
AP-HP, Hôpital Louis Mourier, Réanimation Médico-chirurgicale, 178 rue des Renouillers, F-92700, Colombes, France. jonathan.messika@aphp.fr.
2
Université Paris Diderot, Sorbonne Paris Cité, IAME, UMRS 1137, F-75018, Paris, France. jonathan.messika@aphp.fr.
3
INSERM, IAME, U1137, F-75018, Paris, France. jonathan.messika@aphp.fr.
4
Present address: Réanimation Médico-chirurgicale, Hôpital Louis Mourier, 178 rue des Renouillers, F-92700, Colombes, France. jonathan.messika@aphp.fr.
5
Université Paris Diderot, Sorbonne Paris Cité, ECEVE, UMRS 1123, F-75010, Paris, France.
6
INSERM, ECEVE, U1123, F-75010, Paris, France.
7
INSERM, CIC-EC 1425, UMR 1123, F-75010, Paris, France.
8
AP-HP, Hôpital Louis Mourier, Réanimation Médico-chirurgicale, 178 rue des Renouillers, F-92700, Colombes, France.
9
Centre Hospitalier Départemental de Vendée, Réanimation Médico-Chirurgicale, La Roche-sur-Yon, F-85925 Cedex 9, France.
10
Institut Gustave Roussy, Réanimation Médico-chirurgicale, Villejuif, F-94800, France.
11
CHRU de Montpellier, Service de Neurologie, Inserm U1061, Montpellier, F-34000, France.
12
APHP, Hôpital Louis Mourier, Département d'Epidémiologie et Recherche Clinique, 178 Rue des Renouillers, Colombes, F-92700, France.
13
Université Paris Diderot, UMR 1123, Sorbonne Paris Cité, Paris, France.
14
Université Paris Diderot, Sorbonne Paris Cité, IAME, UMRS 1137, F-75018, Paris, France.
15
INSERM, IAME, U1137, F-75018, Paris, France.

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.

KEYWORDS:

Critical care; Music intervention; Non-invasive ventilation; Respiratory comfort

PMID:
27618935
PMCID:
PMC5020479
DOI:
10.1186/s13063-016-1574-z
[Indexed for MEDLINE]
Free PMC Article

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