AnxietyPhase 2NCT00440700
Anxiety Self-Management for ICU Patients Receiving Mechanical Ventilation
A Phase 2 study testing Anxiety Self-Management, Patient preferred relaxing music in people with Anxiety, run by University of Minnesota at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety
- What is being tested?
- Anxiety Self-Management, Patient preferred relaxing music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 364 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Jun 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- On the ventilator because of a surgical procedure, not alert and unable to provide own consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
About this study
Official title: Reducing Sedative Exposure in Ventilated ICU Patients
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.
Read the 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.
- Conditions
- Anxiety
- Being tested
- Anxiety Self-Management, Patient preferred relaxing music, Control 1: Noise-cancelling headphones, Control 2: Standard of Care
- Keywords
- Ventilator, chronic obstructive pulmonary disease, Anxiety
- Medical subject headings
- Anxiety Disorders, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anxiety Self-Management, Patient preferred relaxing musicBehavioural
Also called self-initiated music listening
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.
Control 1: Noise-cancelling headphonesBehavioural
Also called noise-reduction 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.
Control 2: Standard of CareBehavioural
Usual ICU nursing care.
| Study group | Role | What they receive |
|---|---|---|
| Patient-directed music | Experimental | 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. Receives: Behavioral: Anxiety Self-Management, Patient preferred relaxing music |
| Headphones | Active comparator | Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired. Receives: Behavioral: Control 1: Noise-cancelling headphones |
| Standard of Care | Other | Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily. Receives: Behavioral: Control 2: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Daily up to 30 days
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.
Measured: Daily up to 30 days
Secondary outcomes (3)
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 .
Measured: 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 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.
Measured: From initial intubation date to extubation or death, whichever came first, assessed up to 30 days.
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).
Measured: Daily up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2007 (estimated)
- Study startJul 2006
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linda Chlan, PhD, RN, Principal investigator, University of Minnesota School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00440700
- Sponsor's protocol ID
- 0601M79066
- Status last verified
- Apr 2013
- First submitted
- 23 Feb 2007
- Last updated
- 26 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 35377238Chlan 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.
PubMed 29727366Chlan 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.
PubMed 23689789
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Sedative Exposure in Ventilated ICU Patients
- ClinicalTrials.gov ID
- NCT00440700
- Acronym / sponsor ID
- 0601M79066
- Conditions
- Anxiety
- Keywords
- Ventilator, chronic obstructive pulmonary disease, Anxiety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 364 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 27 Feb 2007 (estimated)
- Results
- Posted 26 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient-directed music | Experimental | Behavioral: Anxiety Self-Management, Patient preferred relaxing musicPatients 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 | Active comparator | Behavioral: Control 1: Noise-cancelling headphonesNoise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired. |
| Standard of Care | Other | Behavioral: Control 2: Standard of CarePatients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- On the ventilator because of a surgical procedure, not alert and unable to provide own consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anxiety Self-Management, Patient preferred relaxing musicAlso: self-initiated music listeningExperimental 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. | Behavioural | Patient-directed music |
| Control 1: Noise-cancelling headphonesAlso: noise-reduction headphonesControl 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. | Behavioural | Headphones |
| Control 2: Standard of CareUsual ICU nursing care. | Behavioural | Standard of Care |
Primary outcome
Sedative Exposure
Time frame: 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
Time frame: 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.
3 secondary outcomes
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
Length of Mechanical Ventilatory Support
Time frame: From initial intubation date to extubation or death, whichever came first, assessed up to 30 days.
Urinary Cortisol
Time frame: Daily up to 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35377238Heiderscheit 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.
- Derived from this study: PubMed 29727366Chlan 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.
- Derived from this study: PubMed 23689789Chlan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Chlan, PhD, RN principal investigator
University of Minnesota School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anxiety Self-Management, Patient preferred relaxing music in people with Anxiety, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sedative Exposure (time frame: Daily up to 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00440700, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2013.