Anxiety Self-Management for ICU Patients Receiving Mechanical Ventilation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00440700
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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Patient-directed Music     Headphones     Usual Care  
STARTED     122     118     124  
COMPLETED     114     110     120  
NOT COMPLETED     8     8     4  
Withdrawal by Subject                 8                 8                 4  



  Baseline Characteristics


  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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