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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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
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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
  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.
Total Total of all reporting groups

Baseline Measures
    Patient-directed Music     Headphones     Usual Care     Total  
Number of Participants  
[units: participants]
  122     118     124     364  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     88     90     95     273  
>=65 years     34     28     29     91  
Age  
[units: years]
Mean ± Standard Deviation
  60.4  ± 15.4     59.4  ± 14.3     57.8  ± 13.5     59.2  ± 14.4  
Gender  
[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
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Time Frame 1 year
Additional Description No text entered.

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.

Serious Adverse Events
    Patient-directed Music     Headphones     Usual Care  
Total, serious adverse events        
# participants affected / at risk     5/122 (4.10%)     5/118 (4.24%)     7/124 (5.65%)  
Cardiac disorders        
Cardiac arrest * 1      
# participants affected / at risk     0/122 (0.00%)     0/118 (0.00%)     1/124 (0.81%)  
# events     0     0     1  
Nervous system disorders        
Seizure activity * 1 [3]      
# participants affected / at risk     1/122 (0.82%)     0/118 (0.00%)     1/124 (0.81%)  
# events     1     0     1  
Respiratory, thoracic and mediastinal disorders        
Self-extubation * 1      
# participants affected / at risk     4/122 (3.28%)     5/118 (4.24%)     5/124 (4.03%)  
# events     4     5     5  
* Events were collected by non-systematic assessment
1 Term from vocabulary, Serious
[3] seizure activity noted in patient after ICU admission for stroke




  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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