Pain Clinical Trial
— DDMOfficial title:
Decreasing Delirium Through Music in Critically Ill Older Adults
Verified date | February 2024 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Critically ill older adults admitted to the intensive care unit (ICU) are at a higher risk to develop delirium, which predisposes them to longer lengths of ICU and hospital stay, increased in-patient mortality, and higher risk of new acquired cognitive impairment and dementia. Music listening is a non-pharmacological intervention that holds potential to decrease ICU delirium. The investigators propose a randomized controlled trial to evaluate the efficacy of a seven-day slow-tempo music intervention on the primary outcome of delirium/coma free days among mechanically ventilated, critically ill older adults.
Status | Active, not recruiting |
Enrollment | 160 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | Inclusion Criteria: 1. Age 50 years or older. 2. English speaking. 3. Admitted to the intensive care unit (medical or surgical). 4. Expected mechanical ventilator support for =48 hours. 5. Consentable through a legally authorized representative. 6. Have access to a telephone. Exclusion Criteria: 1. History of dementing illnesses and other neurodegenerative diseases such as Alzheimer's disease or vascular dementia. 2. Psychiatric illness which is not well controlled. 3. Alcohol withdrawal symptoms/concern for withdrawal. 4. Suspected or confirmed drug intoxication/overdose 5. Traumatic brain injury, ischemic or hemorrhagic cerebrovascular accident, or undergoing neurosurgery. 6. Uncorrected hearing or vision impairment including legal blindness. 7. Incarcerated at the time of study enrollment. 8. Enrolled in another clinical trial which does not permit co-enrollment. 9. Any medical condition precluding safe use of headphones such as: skin breakdown, burns, facial or skull fractures. |
Country | Name | City | State |
---|---|---|---|
United States | IU Health West Hospital | Avon | Indiana |
United States | Eskenazi Hospital | Indianapolis | Indiana |
United States | IU Health University Hospital | Indianapolis | Indiana |
United States | Methodist Hospital | Indianapolis | Indiana |
United States | Mayo Clinic Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Indiana University | National Institute on Aging (NIA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Days free of delirium and coma | Days free of delirium and coma will be the primary outcome for the trial. Days free of delirium and coma are the number of days after randomization patient is alive free of delirium and not in coma during the seven-day study intervention phase. | Subjects will be followed up to 28 days post randomization | |
Secondary | Delirium Severity | Delirium severity will be assessed twice daily by trained research assistants using the CAM-ICU-7. CAM-ICU-7 is a seven point scale (0-7), derived from the RASS and the CAM-ICU. | Subjects will be followed up to 28 days post randomization | |
Secondary | Pain intensity | Pain will be assessed by trained research assistants utilizing the Critical Care Pain Observation Tool (CPOT), a valid and reliable instrument in critically ill patients with and without delirium.. Scale range 0-8, higher score indicates worse pain. | 4 times daily, before and after each intervention for up to 7 days while in the ICU and then twice daily up to 28 days post randomization | |
Secondary | Anxiety | Anxiety intensity defined as a heightened state of apprehension, agitation, and arousal, will be measured four times daily before and after assigned intervention using a 100-mm Visual Analog Scale-Anxiety (VAS-A). Scale range 0-100, higher score indicates worse anxiety. | 4 times daily, before and after each intervention for up to 7 days while in the ICU and then twice daily up to 28 days post randomization | |
Secondary | Cognition | Cognition will be measured by objective tests of memory, attention, information processing speed and executive cognitive function. The Auditory Verbal Learning Test [AVLT] will be administered using a phone-based format. Score ranges, sum of learning trials 0-75, 30-minute delay 0-15, a lower score indicates a worse outcome. | 3 months post hospital discharge | |
Secondary | Cognition | Cognition will be measured by objective tests of memory, attention, information processing speed and executive cognitive function. The Wechsler Adult Intelligence Scale- III Digit Span test will be administered using a phone-based format. Score range 0-30, a lower score indicates a worse outcome. | 3 months post hospital discharge | |
Secondary | Cognition | Cognition will be measured by objective tests of memory, attention, information processing speed and executive cognitive function. The Symbol Digit Modalities Test will be administered using a phone-based format. Score range 0-110, a lower score indicates a worse outcome. | 3 months post hospital discharge | |
Secondary | Cognition | Cognition will be measured by objective tests of memory, attention, information processing speed and executive cognitive function. The Multilingual Aphasia Examination Controlled Oral Word Association test will be administered using a phone-based format. Score range 0-no max score, a lower score indicates a worse outcome. | 3 months post hospital discharge | |
Secondary | Depression | We will use the Patient Health Questionnaire-9 (PHQ-9) to determine the impact of the music intervention on ICU survivor's mood. Scale range 0-27, higher score indicates worse depression. | 3 months post hospital discharge | |
Secondary | Anxiety | We will use the Generalized Anxiety Disorder Scale (GAD-7) to determine the impact of the music intervention on ICU survivor's anxiety. Scale range 0-21, higher score indicates worse anxiety. | 3 months post hospital discharge |
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