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 measuresANCOVA, 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 eachyear by enhancing personal control while reducing exposure to sedative agents and their serious sideeffects.

Agency
National Institute of Health (NIH)
Institute
National Institute of Nursing Research (NINR)
Type
Research Project (R01)
Project #
5R01NR009295-04
Application #
7558998
Study Section
Nursing Science: Adults and Older Adults Study Section (NSAA)
Program Officer
Huss, Karen
Project Start
2006-04-01
Project End
2011-06-30
Budget Start
2009-02-01
Budget End
2011-06-30
Support Year
4
Fiscal Year
2009
Total Cost
$427,926
Indirect Cost
Name
University of Minnesota Twin Cities
Department
Type
Schools of Nursing
DUNS #
555917996
City
Minneapolis
State
MN
Country
United States
Zip Code
55455
Chlan, Linda L; Heiderscheit, Annette; Skaar, Debra J et al. (2018) Economic Evaluation of a Patient-Directed Music Intervention for ICU Patients Receiving Mechanical Ventilatory Support. Crit Care Med 46:1430-1435
Chlan, Linda L; Heiderscheit, Annette; Skaar, Debra J et al. (2018) The authors reply. Crit Care Med 46:e1085-e1086
Choi, JiYeon; Campbell, Margaret L; Gélinas, Céline et al. (2017) Symptom assessment in non-vocal or cognitively impaired ICU patients: Implications for practice and future research. Heart Lung 46:239-245
Chlan, Linda L; Savik, Kay (2015) Contributors to fatigue in patients receiving mechanical ventilatory support: A descriptive correlational study. Intensive Crit Care Nurs 31:303-8
Tracy, Mary Fran; Chlan, Linda; Staugaitis, Abbey (2015) Perceptions of Patients and Families who Received a Music Intervention During Mechanical Ventilation. Music Med 7:54-58
Chlan, Linda L; Tracy, Mary Fran; Guttormson, Jill et al. (2015) Peripheral muscle strength and correlates of muscle weakness in patients receiving mechanical ventilation. Am J Crit Care 24:e91-8
Chlan, Linda L (2014) Feasibility of Bioelectric Impedance as a Measure of Muscle Mass in Mechanically Ventilated ICU Patients. Open J Nurs 4:51-56
Breckenridge, Stephanie J; Chlan, Linda; Savik, Kay (2014) Impact of tracheostomy placement on anxiety in mechanically ventilated adult ICU patients. Heart Lung 43:392-8
Heiderscheit, Annie; Breckenridge, Stephanie J; Chlan, Linda L et al. (2014) Music preferences of mechanically ventilated patients participating in a randomized controlled trial. Music Med 6:29-38
Chlan, Linda L; Weinert, Craig R; Heiderscheit, Annie et al. (2013) Effects of patient-directed music intervention on anxiety and sedative exposure in critically ill patients receiving mechanical ventilatory support: a randomized clinical trial. JAMA 309:2335-44

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