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Anxiety Self-Management for ICU Patients Receiving Mechanical Ventilation

This study has been completed.
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute Identifier:
First received: February 23, 2007
Last updated: April 24, 2013
Last verified: April 2013
Results First Received: May 23, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Anxiety
Interventions: Behavioral: Anxiety Self-Management, Patient preferred relaxing music
Behavioral: Control 1: Noise-cancelling headphones
Behavioral: Control 2: Standard of Care

  Participant Flow

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Patient-directed Music Patients select preferred music for listening through headphones whenever they like for as long as they like whenever feeling anxious, desire some rest and quiet time, or for listening enjoyment while mechanically ventilated in the ICU.
Headphones Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.
Usual Care Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
Total Total of all reporting groups

Baseline Measures
   Patient-directed Music   Headphones   Usual Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 122   118   124   364 
[Units: Participants]
<=18 years   0   0   0   0 
Between 18 and 65 years   88   90   95   273 
>=65 years   34   28   29   91 
[Units: Years]
Mean (Standard Deviation)
 60.4  (15.4)   59.4  (14.3)   57.8  (13.5)   59.2  (14.4) 
[Units: Participants]
Female   66   54   68   188 
Male   56   64   56   176 
Region of Enrollment 
[Units: Participants]
United States   122   118   124   364 

  Outcome Measures
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1.  Primary:   Sedative Exposure   [ Time Frame: Daily up to 30 days ]

2.  Primary:   State Anxiety   [ Time Frame: Daily up to 30 days ]

3.  Secondary:   Length of ICU Stay   [ Time Frame: From date of ICU admission to extubation or discharge or date of death from any cause, whichever came first assessed up to 60 days ]

4.  Secondary:   Length of Mechanical Ventilatory Support   [ Time Frame: From initial intubation date to extubation or death, whichever came first, assessed up to 30 days. ]

5.  Secondary:   Urinary Cortisol   [ Time Frame: Daily up to 30 days ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Overall limitations of the trial include the challenges of obtaining informed consent from patients' themselves. Many times patients were too sedated or not alert enough to participate in the consent process.

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