Mechanical ventilation is the most frequently used advanced, life-supportive modality in intensive care units (ICUs) to treat respiratory insufficiency from a variety of causes. To reduce anxiety, stress and promote tolerance of mechanical ventilation, nurses frequently administer sedative agents to these patients. While sedation is indicated at times, it is not without serious side effects which include muscle weakness, mental status changes, prolonged ventilatory support, and extended ICU stay. Clinical practice guidelines suggest that non-pharmacologic strategies be tried to reduce patient distress before administering sedatives. However, non-pharmacologic strategies are under-utilized and lack rigorous evaluation in clinical trials that document patient benefit. One non-pharmacologic intervention that shows promise in reducing anxiety after a single treatment but lacks rigorous evaluation on clinically salient outcomes is music. Thus, the primary aim of this clinical trial is to test a patient-directed, as desired music intervention (PDM) on reducing sedative exposure and anxiety in adult ventilated patients, and to examine attendant influences on length of ventilatory support, length of ICU stay, and stress modulation. A sample of 186 alert patients receiving acute ventilatory support will be recruited from 5 ICUs in the urban Midwest for this 3 group experimental design study with repeated measures. Subjects receiving ventilatory support will be randomized to PDM, noise- canceling headphones, or to usual care for up to 30 days. Sedative exposure (aggregate dose and dose frequency), anxiety levels (visual analog scale and State Anxiety Inventory), and 24-hour urinary cortisol samples (stress) will all be collected daily. Primary data analysis will be repeated measures ANCOVA, controlling for illness severity. Long-term objectives of this study are to positively impact important clinical outcomes and quality of life for the millions of ICU patients who experience mechanical ventilation each year by enhancing personal control while reducing exposure to sedative agents and their serious side effects. ? ?
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