Trial Outcomes & Findings for Anxiety Self-Management for ICU Patients Receiving Mechanical Ventilation (NCT NCT00440700)

NCT ID: NCT00440700

Last Updated: 2013-04-26

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 364 participants
• Primary outcome timeframe: Daily up to 30 days
• Results posted on: 2013-04-26

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	122	118	124
Overall Study COMPLETED	114	110	120
Overall Study NOT COMPLETED	8	8	4

Reasons for withdrawal

Measure	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.
Overall Study Withdrawal by Subject	8	8	4

Baseline Characteristics

Anxiety Self-Management for ICU Patients Receiving Mechanical Ventilation

Baseline characteristics by cohort

Measure	Patient-directed Music n=122 Participants 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 n=118 Participants Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.	Usual Care n=124 Participants Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.	Total n=364 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	88 Participants n=93 Participants	90 Participants n=4 Participants	95 Participants n=27 Participants	273 Participants n=483 Participants
Age, Categorical >=65 years	34 Participants n=93 Participants	28 Participants n=4 Participants	29 Participants n=27 Participants	91 Participants n=483 Participants
Age Continuous	60.4 years STANDARD_DEVIATION 15.4 • n=93 Participants	59.4 years STANDARD_DEVIATION 14.3 • n=4 Participants	57.8 years STANDARD_DEVIATION 13.5 • n=27 Participants	59.2 years STANDARD_DEVIATION 14.4 • n=483 Participants
Sex: Female, Male Female	66 Participants n=93 Participants	54 Participants n=4 Participants	68 Participants n=27 Participants	188 Participants n=483 Participants
Sex: Female, Male Male	56 Participants n=93 Participants	64 Participants n=4 Participants	56 Participants n=27 Participants	176 Participants n=483 Participants
Region of Enrollment United States	122 participants n=93 Participants	118 participants n=4 Participants	124 participants n=27 Participants	364 participants n=483 Participants

PRIMARY outcome

Timeframe: Daily up to 30 days

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

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.

Outcome measures

Measure	Patient-directed Music n=87 Participants 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 n=90 Participants Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.	Usual Care n=89 Participants Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
Sedative Exposure	1 exposures/4-hours per day Interval 0.0 to 12.0	7 exposures/4-hours per day Interval 0.0 to 10.0	6 exposures/4-hours per day Interval 0.0 to 12.0

PRIMARY outcome

Timeframe: Daily up to 30 days

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

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.

Outcome measures

Measure	Patient-directed Music n=86 Participants 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 n=81 Participants Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.	Usual Care n=74 Participants Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
State Anxiety	40 units on a scale Standard Deviation 32.4	59 units on a scale Standard Deviation 30.1	55 units on a scale Standard Deviation 29.7

SECONDARY outcome

Timeframe: From date of ICU admission to extubation or discharge or date of death from any cause, whichever came first assessed up to 60 days

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

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 .

Outcome measures

Measure	Patient-directed Music n=122 Participants 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 n=118 Participants Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.	Usual Care n=124 Participants Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
Length of ICU Stay	18.8 days Standard Error .85	19.3 days Standard Error .87	18.7 days Standard Error .85

SECONDARY outcome

Timeframe: From initial intubation date to extubation or death, whichever came first, assessed up to 30 days.

Population: 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.

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.

Outcome measures

Measure	Patient-directed Music n=122 Participants 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 n=118 Participants Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.	Usual Care n=124 Participants Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
Length of Mechanical Ventilatory Support	4.4 days Standard Error .61	5.8 days Standard Error .62	5.9 days Standard Error .60

SECONDARY outcome

Timeframe: Daily up to 30 days

Population: 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.

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).

Outcome measures

Measure	Patient-directed Music n=19 Participants 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 n=27 Participants Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.	Usual Care n=19 Participants Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
Urinary Cortisol	29.3 total milligrams per day Interval 1.0 to 181.4	54 total milligrams per day Interval 8.8 to 241.0	33 total milligrams per day Interval 5.9 to 264.8

Adverse Events

Patient-directed Music

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Headphones

Serious events: 5 serious events

Other events: 1 other events

Deaths: 0 deaths

Usual Care

Serious events: 7 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Patient-directed Music n=122 participants at risk 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 n=118 participants at risk Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.	Usual Care n=124 participants at risk Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
Respiratory, thoracic and mediastinal disorders Self-extubation	3.3% 4/122 • Number of events 4 • 1 year	4.2% 5/118 • Number of events 5 • 1 year	4.0% 5/124 • Number of events 5 • 1 year
Cardiac disorders Cardiac arrest	0.00% 0/122 • 1 year	0.00% 0/118 • 1 year	0.81% 1/124 • Number of events 1 • 1 year
Nervous system disorders Seizure activity	0.82% 1/122 • Number of events 1 • 1 year	0.00% 0/118 • 1 year	0.81% 1/124 • Number of events 1 • 1 year

Other adverse events

Measure	Patient-directed Music n=122 participants at risk 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 n=118 participants at risk Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.	Usual Care n=124 participants at risk Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
Ear and labyrinth disorders Ear congestion	0.00% 0/122 • 1 year	0.85% 1/118 • Number of events 1 • 1 year	0.00% 0/124 • 1 year
Ear and labyrinth disorders Impaired hearing	0.00% 0/122 • 1 year	0.85% 1/118 • Number of events 1 • 1 year	0.81% 1/124 • Number of events 1 • 1 year

Additional Information

Dr. Linda Chlan

University of Minnesota

Phone: 612-624-6658

Email: chlan001@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place