CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 364 enrolled
Drug / intervention
Anxiety Self-Management, Patient preferred relaxing music +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00440700
NCT00440700Phase 2Completed

Reducing Sedative Exposure in Ventilated ICU Patients

University of Minnesota·interventional·Posted Feb 27, 2007·Updated Apr 26, 2013

In Brief

A Phase 2 clinical trial evaluating Anxiety Self-Management, Patient preferred relaxing music, Control 1: Noise-cancelling headphones, and 1 other intervention for Anxiety. Completed, enrolled 364 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnxiety
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 27, 2007
Enrollment StartJul 1, 2006
Primary CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 19.3 years ago

Interventions

Anxiety Self-Management, Patient preferred relaxing musicbehavioral

Experimental group randomized to patient-directed music intervention where subjects listened to tailored, self-selected music as desired (frequency and length determined by the individual subject) each day they are receiving mechanical ventilatory support.

Control 1: Noise-cancelling headphonesbehavioral

Control group: noise-canceling headphones only where subjects wear headphones as desired (frequency and length determined by the individual subject) each day they are receiving mechanical ventilatory support.

Control 2: Standard of Carebehavioral

Usual ICU nursing care.