Phase 2
N=364
Anxiety Self-Management for ICU Patients Receiving Mechanical Ventilation
Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT00440700 ↗Enrolled (actual)
364
Serious AEs
4.7%
Results posted
Apr 2013
Primary outcome: Primary: Sedative Exposure — 1; 7; 6 exposures/4-hours per day
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Anxiety Self-Management, Patient preferred relaxing music (Behavioral); Control 1: Noise-cancelling headphones (Behavioral); Control 2: Standard of Care (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sedative Exposure |
1; 7; 6 | — |
| PRIMARY State Anxiety |
40; 59; 55 | <0.05 sig |
| SECONDARY Length of ICU Stay |
18.8; 19.3; 18.7 | — |
| SECONDARY Length of Mechanical Ventilatory Support |
4.4; 5.8; 5.9 | <0.05 sig |
| SECONDARY Urinary Cortisol |
29.3; 54; 33 | <0.05 sig |
Summary
The purpose of this study is to test whether patients who are receiving mechanical ventilation in the ICU who listened to preferred, relaxing music whenever they desire for as long as they desire will have less anxiety, receive fewer medications, stay in the ICU for a shorter time, and experience less stress than patients who do not listen to music.
Eligibility Criteria
Inclusion Criteria
- Any patient who is alert, on the ventilator because there is some condition involving the lungs preventing him/her from breathing on his/her own and willing and able to provide own consent.
Exclusion Criteria
- On the ventilator because of a surgical procedure, not alert and unable to provide own consent.
Data sourced from ClinicalTrials.gov (NCT00440700). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.