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.
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  
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 ]

Measure Type Primary
Measure Title Sedative Exposure
Measure Description Sedative exposure was measured by: 1) the number (dose frequency) of sedative medication doses administered in a 4-hour time period each day and 2) by an aggregate dose intensity of sedative medications administered in a 4-hour time period each day based on all subjects receiving sedative medications on any individual study day yielding a sedation intensity score. A sedation intensity score was calculated for each study group each study protocol day, up to 30 days. Higher sedation intensity scores indicate more sedative exposure. If a subject did not receive any sedation, the sedative exposure score is zero for that respective day.
Time Frame Daily up to 30 days  
Safety Issue No  

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.
Participants with 2 or more days of study enrollment data were included in the analysis for this aim.

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  
Number of Participants Analyzed  
[units: participants]
  87     90     89  
Sedative Exposure  
[units: exposures/4-hours per day]
Median ( Full Range )
  1  
  ( 0 to 12 )  
  7  
  ( 0 to 10 )  
  6  
  ( 0 to 12 )  

No statistical analysis provided for Sedative Exposure



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

Measure Type Primary
Measure Title State Anxiety
Measure Description Participants reported their current level of anxiety each day enrolled in the study in response to the question "how are you feeling today"/ The Visual analog scale-anxiety was used to evaluate the self-report of anxiety. Scores range from 0 = not anxious at all to 100 = the most anxious ever. Higher numbers indicate greater anxiety. Daily anxiety scores from all subjects were combined and analyzed for each group resulting in an overall mean anxiety score at the end of the study protocol of 30 days.
Time Frame Daily up to 30 days  
Safety Issue No  

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.
Participants with 3 or more visual analog scale-anxiety ratings were included in the analysis.

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  
Number of Participants Analyzed  
[units: participants]
  86     81     74  
State Anxiety  
[units: units on a scale]
Mean ± Standard Deviation
  40  ± 32.4     59  ± 30.1     55  ± 29.7  


Statistical Analysis 1 for State Anxiety
Groups [1] All groups
Method [2] Mixed Models Analysis
P Value [3] <0.05
Slope [4] 15.5
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Mixed models analysis was used to determine if there were any differences in anxiety levels in patients who listen to music as compared to headphones only or usual ICU care.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] 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.
[4] Other relevant estimation information:
  No text entered.



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 ]

Measure Type Secondary
Measure Title Length of ICU Stay
Measure Description Length of ICU stay was measured in days from the first day participant was admitted to the unit until discharged, transferred, or died in the ICU. This was the total time that any participant was in the intensive care unit which could have been longer than the 30 study protocol .
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  
Safety Issue No  

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.
The number of participants includes all of those patients who were enrolled into the study protocol, regardless of their length of study participation.

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  
Number of Participants Analyzed  
[units: participants]
  122     118     124  
Length of ICU Stay  
[units: days]
Mean ± Standard Error
  18.8  ± .85     19.3  ± .87     18.7  ± .85  

No statistical analysis provided for Length of ICU Stay



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. ]

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.  
Safety Issue No  

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  
Number of 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
Method [2] Kruskal-Wallis
P Value [3] <0.05
Mean Difference (Final Values) [4] 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] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] 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.
[4] Other relevant estimation information:
  Usual care was the reference comparison group.



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

Measure Type Secondary
Measure Title Urinary Cortisol
Measure Description Stress was measured by the biomarker urinary cortisol. 24-hour urine collections were obtained from eligible participants who were not receiving steroids or other medications known to affect cortisol and who had intact renal function. 24-hour urinary cortisol results were used as an integrative measure of stress (mg/day).
Time Frame Daily up to 30 days  
Safety Issue No  

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.
All participants with functioning kidneys who were not receiving steroids or other medications known to affect cortisol and who had two or more 24-hour urine collections were included in the analysis.

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  
Number of Participants Analyzed  
[units: participants]
  19     27     19  
Urinary Cortisol  
[units: total milligrams per day]
Median ( Full Range )
  29.3  
  ( 1 to 181.4 )  
  54  
  ( 8.8 to 241 )  
  33  
  ( 5.9 to 264.8 )  


Statistical Analysis 1 for Urinary Cortisol
Groups [1] All groups
Method [2] Mixed Models Analysis
P Value [3] <0.05
Slope [4] 5
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Cortisol levels were compared among all 3 groups.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] 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.
[4] Other relevant estimation information:
  No text entered.




  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