Anxiety Self-Management for ICU Patients Receiving Mechanical Ventilation
Primary Purpose
Anxiety
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Anxiety Self-Management, Patient preferred relaxing music
Control 1: Noise-cancelling headphones
Control 2: Standard of Care
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety focused on measuring Ventilator, chronic obstructive pulmonary disease, Anxiety
Eligibility Criteria
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.
Sites / Locations
- University of Minnesota Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Other
Arm Label
Patient-directed music
Headphones
Standard of Care
Arm Description
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.
Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.
Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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 .
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.
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).
Full Information
NCT ID
NCT00440700
First Posted
February 23, 2007
Last Updated
April 24, 2013
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT00440700
Brief Title
Anxiety Self-Management for ICU Patients Receiving Mechanical Ventilation
Official Title
Reducing Sedative Exposure in Ventilated ICU Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
Ventilator, chronic obstructive pulmonary disease, Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
364 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient-directed music
Arm Type
Experimental
Arm Description
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.
Arm Title
Headphones
Arm Type
Active Comparator
Arm Description
Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.
Arm Title
Standard of Care
Arm Type
Other
Arm Description
Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
Intervention Type
Behavioral
Intervention Name(s)
Anxiety Self-Management, Patient preferred relaxing music
Other Intervention Name(s)
self-initiated music listening
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control 1: Noise-cancelling headphones
Other Intervention Name(s)
noise-reduction headphones
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control 2: Standard of Care
Intervention Description
Usual ICU nursing care.
Primary Outcome Measure Information:
Title
Sedative Exposure
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
Title
State Anxiety
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
Secondary Outcome Measure Information:
Title
Length of ICU Stay
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
Title
Length of Mechanical Ventilatory Support
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.
Title
Urinary Cortisol
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Chlan, PhD, RN
Organizational Affiliation
University of Minnesota School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35377238
Citation
Heiderscheit A, Johnson K, Chlan LL. Analysis of Preferred Music of Mechanically Ventilated Intensive Care Unit Patients Enrolled in a Randomized Controlled Trial. J Integr Complement Med. 2022 Jun;28(6):517-529. doi: 10.1089/jicm.2021.0446. Epub 2022 Apr 4.
Results Reference
derived
PubMed Identifier
29727366
Citation
Chlan LL, Heiderscheit A, Skaar DJ, Neidecker MV. Economic Evaluation of a Patient-Directed Music Intervention for ICU Patients Receiving Mechanical Ventilatory Support. Crit Care Med. 2018 Sep;46(9):1430-1435. doi: 10.1097/CCM.0000000000003199.
Results Reference
derived
PubMed Identifier
23689789
Citation
Chlan LL, Weinert CR, Heiderscheit A, Tracy MF, Skaar DJ, Guttormson JL, Savik K. Effects of patient-directed music intervention on anxiety and sedative exposure in critically ill patients receiving mechanical ventilatory support: a randomized clinical trial. JAMA. 2013 Jun 12;309(22):2335-44. doi: 10.1001/jama.2013.5670.
Results Reference
derived
Learn more about this trial
Anxiety Self-Management for ICU Patients Receiving Mechanical Ventilation
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