A musical intervention for respiratory comfort during noninvasive ventilation in the ICU.

Discomfort associated with noninvasive ventilation (NIV) may participate in its failure. We aimed to determine the effect of a musical intervention on respiratory discomfort during NIV in patients with acute respiratory failure (ARF).An open-label, controlled trial was performed over three centres. Patients requiring NIV for ARF were randomised to either a musical intervention group (where they received a musical intervention and were subjected to visual deprivation during the first 30 min of each NIV session), a sensory deprivation group (where they wore insulating headphones and were subjected to visual deprivation during the first 30 min of each NIV session), or a control group (where they received NIV as routinely performed). The primary outcome was the change in respiratory discomfort before and after 30 min of the first NIV session.A total of 113 patients were randomised (36 in the musical intervention group, 38 in the sensory deprivation group and 39 in the control group). Median (interquartile range (IQR)) change in respiratory discomfort was 0 (-1; 1) between the musical intervention and control groups (p=0.7). Between groups comparison did not evidence any significant variation of respiratory parameters across time or health-related quality of life (HRQoL) at day-90. The Peri-traumatic Distress Inventory (PDI) at intensive care unit (ICU) discharge was reduced in musical intervention group patients. However, a 30 min musical intervention did not reduce respiratory discomfort during NIV for ARF in comparison to conventional care or sensory deprivation.

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).

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.