Clinical outcomes in the study
| Outcome | Group | p-value | ||
| Control (n=39) | Sensory deprivation (n=38) | Musical intervention (n=36) | ||
| Respiratory discomfort# | ||||
| At T0 of the first NIV session | 4 1–6 | 5 2–6 | 5 1.5–7 | – |
| At T30 of the first NIV session | 3 (0–5) | 4 (2–5) | 4 (2–5.5) | – |
| Primary outcome | ||||
| T0 to T30 change in respiratory discomfort during the first NIV session | −1 (−2; 0) | 0 (−2; 0) | −1 (−3; 1.1) | 0.86++ and 0.79§§ |
| Secondary outcomes | ||||
| Adequacy¶ of the prescribed and actual duration of the NIV session | 1.07 (1.00–1.33) | 1.00 (0.87–1.26) | 1.08 (0.93–1.26) | 0.29 |
| Patients requiring physical restraint during NIV | 2 (5.1) | 0 (0) | 0 (0) | 0.33 |
| Patients requiring sedative or anxiolytic treatments+ during NIV | 2 (5.1) | 4 (10.5) | 1 (2.8) | 0.32 |
| Patients requiring endotracheal intubations | 3 (7.7) | 1 (2.6) | 0 | 0.32 |
| PDI§ at ICU discharge | 16 (12–25) | 16 (5–23) | 8 (5–13) | 0.03 |
| Overall assessmentf of NIV at ICU discharge | ||||
| Discomfort | 5 (2–6) | 5 (2–8.5) | 4 (1–5) | 0.21 |
| Satisfaction | 7.5 (5–9) | 6.3 (5–9.5) | 8 (5.2–9) | 0.78 |
| Trauma | 3.5 (0–7) | 4 (0–7.5) | 2 (0–5) | 0.72 |
| HADS## score at day-90 | 12 (8.5–20.5) | 16.5 (11–21) | 10 (8–16) | 0.14 |
| Anxiety sub-score | 6 (3–9) | 6 (5–11) | 5 (3–9) | 0.17 |
| Depression sub-score | 7 (4–10) | 9 (4–13) | 5 (4–10) | 0.33 |
| SF-36## score at day-90 | ||||
| Physical sub-score | 46 (27.1–61) | 42.7 (22.9–64.4) | 45.2 (32.1–63.3) | 0.75 |
| Mental sub-score | 53.8 (31.1–70.5) | 55.4 (22.8–72.3) | 65.5 (30.1–87) | 0.22 |
| PDI§ at day-90 | 12 (4–20) | 14 (8–20) | 9 (5–12) | 0.18 |
| Overall assessmentf of NIV at day-90 | ||||
| Discomfort | 4 (1–6) | 6 (3–9) | 4 (2–7) | 0.29 |
| Satisfaction | 10 (8–10) | 5 (3–8) | 8 (7–10) | 0.02 |
| Trauma | 1 (0–8) | 2 (0–8) | 0 (0–5) | 0.78 |
| Other outcomes | ||||
| Length of first NIV session min | 70 (60–140) | 60 (50–75) | 82.5 (60–145) | 0.21 |
| Number of NIV sessions per patient | 7 (3–17) | 6.5 (4–10) | 5.5 (2–8.5) | 0.06 |
| Length of NIV support days | 3 (2–5) | 3 (2–4) | 3 (2–4) | 0.16 |
| Length of ICU stay days | 7 (4–9) | 6 (3–10) | 6 (3–10.5) | 0.63 |
| ICU survival | 36 (92.3) | 38 (100) | 33 (91.7) | 0.21 |
| Patients with a do-not-intubate decision | 10 (25.6) | 4 (10.5) | 7 (19.4) | 0.23 |
| Day-90 survival¶¶ | 21 (53.9) | 22 (57.9) | 20 (55.6) | 0.84 |
Data is presented as n (%) or median (IQR). p-Values measure the comparison between the three groups unless otherwise stated. NIV: noninvasive ventilation; T0: time of assessment of respiratory discomfort prior to each NIV session; T30: time of the assessment of respiratory discomfort after 30 min of each NIV session; PDI: Peri-traumatic Distress Inventory; ICU: intensive care unit; HADS: Hospital Anxiety and Depression Scale; SF-36: 36-item Short-Form Health Survey; IQR: interquartile range. #: the assessment of respiratory discomfort used a visual scale, which combined numeric and analogic evaluation. The patients were asked to rate the intensity of their dyspnoea on a 10-cm long ruler shaped like an arrow. It was bounded by “0: no respiratory discomfort” (the smallest base of the arrow) and to the right “10: maximal respiratory discomfort” (the head of the arrow). ¶: the adequacy of the prescribed durations of the NIV session and their actual durations was calculated as the sum of the actual duration of all NIV sessions per patient divided by the sum of their prescribed time; +: the Richmond Agitation–Sedation Scale (RASS) is a 10-point scale, ranging from −5 to +4, where the lowest score (−5: unarousable) equals deeper sedation and the highest score (+4: combative) indicates major agitation; §: post-traumatic stress disorder (PTSD) related symptoms were assessed using the PDI scale. The PDI is a 13-item questionnaire, each item being scored from 0–4, with a higher score indicating a higher burden of PTSD-related symptoms; f: NIV-associated discomfort, satisfaction and trauma were assessed with a 0–10 numeric–visual scale at ICU discharge and a 0–10 numeric–verbal scale at day-90 (0: the absence of symptoms and –10: the maximum level of symptoms); ##: health-related quality of life (HRQoL) was measured using the physical and mental sub-scales of the SF-36 and HADS questionnaires. The SF-36 is a 36-item questionnaire scored from 0–100. The lower the score the more disability and the higher the score the less disability (a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability). The HADS is a 14-item questionnaire, each item being scored from 0–3, with a higher score indicating a higher level of anxiety or depression (a cut-off point of eight out of 21 identifies either anxiety or depression); ¶¶: vital status was assessed for 63 subjects at day-90; ++: p-value for the comparison of the musical intervention group versus the control group; §§: p-value for the comparison of the sensory deprivation group versus the control group.