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Anxiety Self-Management for ICU Patients Receiving Mechanical Ventilation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00440700
First Posted: February 27, 2007
Last Update Posted: April 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
Results First Submitted: May 23, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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.
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.
Total Total of all reporting groups

Baseline Measures
   Patient-directed Music   Headphones   Usual Care   Total 
Overall Participants Analyzed 
[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. ]
  Hide Outcome Measure 4

Measure Type Secondary
Measure Title Length of Mechanical Ventilatory Support
Measure Description Length of mechanical ventilatory support was defined as the number of days from initial intubation and placement on mechanical ventilation to the day of extubation or death for participants in each group.
Time Frame From initial intubation date to extubation or death, whichever came first, assessed up to 30 days.  

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.
Includes all subjects enrolled regardless of length of protocol participation. Mean number of days mechanically ventilated was calculated for the subjects randomized to each group/arm.

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.

Measured Values
   Patient-directed Music   Headphones   Usual Care 
Participants Analyzed 
[Units: Participants]
 122   118   124 
Length of Mechanical Ventilatory Support 
[Units: Days]
Mean (Standard Error)
 4.4  (.61)   5.8  (.62)   5.9  (.60) 


Statistical Analysis 1 for Length of Mechanical Ventilatory Support
Groups [1] Patient-directed Music vs. Usual Care
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Kruskal-Wallis
P Value [4] <0.05
Mean Difference (Final Values) [5] 1.5
Standard Error of the mean (0.61)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Length of mechanical ventilatory support was assessed among all 3 groups. Usual usual care was the reference group as compared to the experimental patient-directed music group.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  Usual care was the reference comparison group.



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.


  More Information