Anxiety
Conditions
Keywords
Ventilator, chronic obstructive pulmonary disease, Anxiety
Brief summary
The purpose of this study is to test whether patients who are receiving mechanical ventilation in the ICU who listened to preferred, relaxing music whenever they desire for as long as they desire will have less anxiety, receive fewer medications, stay in the ICU for a shorter time, and experience less stress than patients who do not listen to music.
Detailed description
A three group randomized trial with repeated measures. Participants are assigned by chance to one of three groups: 1) patient-directed, as desired music listening through headphones, 2) noise-canceling headphones only, or 3) usual care. Participants remain in the study, up to 30 days, as long as they are receiving mechanical ventilation in the ICU, choose to withdraw, or become unable to complete the daily anxiety assessments. Information is collected daily on patient-perceived anxiety levels (visual analog scale & State Anxiety Inventory), ventilator settings, and all medications received. Urine is collected each day the participant is on the ventilator to determine level of stress (cortisol) if the kidneys are functioning appropriately and the participant is not receiving medications known to influence cortisol levels. Mechanical ventilation is a common treatment for respiratory problems for patients in the ICU. Patients receiving mechanical ventilation experience much anxiety and distress from the placement of the endotracheal tube (breathing tube) and the mechanical ventilator itself. The usual treatment for these symptoms are medications, which are very potent and have numerous adverse side effects, removing patient involvement and control from managing these symptoms. Music has been shown to decrease anxiety and promote relaxation in limited, single listening intervention studies with patients in the ICU on ventilators. This study tests whether having patients listen to preferred music (familiar & comforting) whenever feeling anxious and wanting to relax for as long as they would like to listen to music through headphones throughout the entire time they are on the ventilator can improve outcomes such as less anxiety, shorter time on the ventilator, receipt of fewer medications, and less stress when compared to patients who do not listen to music while they are on the ventilator. Results from this study will advance nursing science by providing evidence on the efficacy of a simple, self-directed intervention that the millions of patients who receive mechanical ventilation each year in the ICU can use themselves to treat the very common symptoms of anxiety and distress. Results from this study will expand the knowledge base of adjunctive interventions that can be implemented in the ICU to involve patients directly in managing their own symptoms, ultimately improving patient outcomes. Patients who are alert and can provide consent are invited to participate if they are on the ventilator in one of the participating ICUs. Patients remain in the study for as long as they are on the ventilator (up to 30 days) and can provide daily assessment of their anxiety levels. Patients are free to withdraw, however, at any time. Patients randomized to music receive an assessment of their music preferences by a professional music therapist. The music therapist then develops a music collection for each participant, based in individual preferences, that is kept at the bedside throughout the duration of being on the ventilator. The music therapist also visits with music participants' daily to determine if preferences have changed and if he/she desires additional music compact disks (CDs) to be kept at the bedside. Data is collected from the medical record on all medications and ventilator settings each day the participant is enrolled in the study. All urine is collected each day the participant remains in the study if the kidneys are functioning properly and the participant is not receiving medications known to influence cortisol, a marker for an integrative level of stress.
Interventions
BEHAVIORALAnxiety Self-Management, Patient preferred relaxing music
Experimental group randomized to patient-directed music intervention where subjects listened to tailored, self-selected music as desired (frequency and length determined by the individual subject) each day they are receiving mechanical ventilatory support.
BEHAVIORALControl 1: Noise-cancelling headphones
Control group: noise-canceling headphones only where subjects wear headphones as desired (frequency and length determined by the individual subject) each day they are receiving mechanical ventilatory support.
BEHAVIORALControl 2: Standard of Care
Usual ICU nursing care.
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Any patient who is alert, on the ventilator because there is some condition involving the lungs preventing him/her from breathing on his/her own and willing and able to provide own consent.
Exclusion criteria
* On the ventilator because of a surgical procedure, not alert and unable to provide own consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sedative Exposure | Daily up to 30 days | 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. |
| State Anxiety | Daily up to 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of ICU Stay | From date of ICU admission to extubation or discharge or date of death from any cause, whichever came first assessed up to 60 days | 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 . |
| Length of Mechanical Ventilatory Support | From initial intubation date to extubation or death, whichever came first, assessed up to 30 days. | 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. |
| Urinary Cortisol | Daily up to 30 days | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 122 |
| Headphones Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired. | 118 |
| Usual Care Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily. | 124 |
| Total | 364 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 8 | 8 | 4 |
Baseline characteristics
| Characteristic | Headphones | Usual Care | Patient-directed Music | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 28 Participants | 29 Participants | 34 Participants | 91 Participants |
| Age, Categorical Between 18 and 65 years | 90 Participants | 95 Participants | 88 Participants | 273 Participants |
| Age Continuous | 59.4 years STANDARD_DEVIATION 14.3 | 57.8 years STANDARD_DEVIATION 13.5 | 60.4 years STANDARD_DEVIATION 15.4 | 59.2 years STANDARD_DEVIATION 14.4 |
| Region of Enrollment United States | 118 participants | 124 participants | 122 participants | 364 participants |
| Sex: Female, Male Female | 54 Participants | 68 Participants | 66 Participants | 188 Participants |
| Sex: Female, Male Male | 64 Participants | 56 Participants | 56 Participants | 176 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 122 | 1 / 118 | 1 / 124 |
| serious Total, serious adverse events | 5 / 122 | 5 / 118 | 7 / 124 |
Outcome results
Primary
Sedative Exposure
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
Population: Participants with 2 or more days of study enrollment data were included in the analysis for this aim.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patient-directed Music | Sedative Exposure | 1 exposures/4-hours per day |
| Headphones | Sedative Exposure | 7 exposures/4-hours per day |
| Usual Care | Sedative Exposure | 6 exposures/4-hours per day |
Primary
State Anxiety
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
Population: Participants with 3 or more visual analog scale-anxiety ratings were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient-directed Music | State Anxiety | 40 units on a scale | Standard Deviation 32.4 |
| Headphones | State Anxiety | 59 units on a scale | Standard Deviation 30.1 |
| Usual Care | State Anxiety | 55 units on a scale | Standard Deviation 29.7 |
Comparison: 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.p-value: <0.05Mixed Models Analysis
Secondary
Length of ICU Stay
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
Population: The number of participants includes all of those patients who were enrolled into the study protocol, regardless of their length of study participation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient-directed Music | Length of ICU Stay | 18.8 days | Standard Error 0.85 |
| Headphones | Length of ICU Stay | 19.3 days | Standard Error 0.87 |
| Usual Care | Length of ICU Stay | 18.7 days | Standard Error 0.85 |
Secondary
Length of Mechanical Ventilatory Support
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: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient-directed Music | Length of Mechanical Ventilatory Support | 4.4 days | Standard Error 0.61 |
| Headphones | Length of Mechanical Ventilatory Support | 5.8 days | Standard Error 0.62 |
| Usual Care | Length of Mechanical Ventilatory Support | 5.9 days | Standard Error 0.6 |
Comparison: 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.p-value: <0.05Kruskal-Wallis
Secondary
Urinary Cortisol
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
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patient-directed Music | Urinary Cortisol | 29.3 total milligrams per day |
| Headphones | Urinary Cortisol | 54 total milligrams per day |
| Usual Care | Urinary Cortisol | 33 total milligrams per day |
Comparison: Cortisol levels were compared among all 3 groups.p-value: <0.05Mixed Models Analysis