CLINICAL TRIAL

Slow Tempo Music for Delirium

Recruiting · 18+ · All Sexes · Indianapolis, IN

This study is evaluating whether listening to slow-tempo music may help prevent delirium in older adults in the intensive care unit.

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About the trial for Delirium

Eligible Conditions
Pain · Anxiety · Intensive Care Unit Delirium · Delirium · Intensive Care Acquired Cognitive Impairment

Treatment Groups

This trial involves 2 different treatments. Slow Tempo Music is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Slow Tempo Music
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Attention Control
OTHER

Eligibility

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The person was admitted to the intensive care unit for medical care or surgical care. show original
The patient is expected to need mechanical ventilator support for at least 48 hours. show original
The term consentable can be used to describe someone or something that is able to give or withhold consent through a legally authorized representative. show original
The person is over the age of 50. show original
People who speak English. show original
A telephone is necessary in order to have access to it. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 3 months post intervention
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months post intervention
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 3 months post intervention.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Slow Tempo Music will improve 1 primary outcome, 1 secondary outcome, and 4 other outcomes in patients with Delirium. Measurement will happen over the course of Subjects will be followed up to 28 days post randomization.

Delirium Severity
SUBJECTS WILL BE FOLLOWED UP TO 28 DAYS POST RANDOMIZATION
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
Days free of delirium and coma
SUBJECTS WILL BE FOLLOWED UP TO 28 DAYS POST RANDOMIZATION
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
Pain intensity
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
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.
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
Anxiety
3 MONTHS POST INTERVENTION
We will use the Generalized Anxiety Disorder Scale (GAD-7) to determine the impact of the music intervention on ICU survivor's anxiety
3 MONTHS POST INTERVENTION
Depression
3 MONTHS POST INTERVENTION
We will use the Patient Health Questionnaire-9 (PHQ-9) to determine the impact of the music intervention on ICU survivor's mood.
3 MONTHS POST INTERVENTION
Cognition
3 MONTHS POST INTERVENTION
Cognition will be measured by 4 objective tests of memory, attention, information processing speed, and executive cognitive function (Auditory Verbal Learning Test [AVLT], Digit Span, and Symbol Digit Modalities Test [SDMT], and Controlled Oral Word Association test [COWA]) using a telephone-based administration format, the Indiana University Telephone-Based Assessment of Neuropsychological Status (IU- TBANS) at 3-months post hospital discharge.
3 MONTHS POST INTERVENTION

Who is running the study

Principal Investigator
B. K.
Prof. Babar Khan,, MD
Indiana University

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the primary cause of delirium?

While the primary cause of delirium is not known, this retrospective study indicates that delirium is a marker for illness that is not being adequately treated.

Anonymous Patient Answer

How does slow tempo music work?

TEM music lowers the arousal level when an individual is experiencing delirium as evidenced by reduced delirium severity and faster recovery from delirium when music is played.

Anonymous Patient Answer

Can delirium be cured?

Given appropriate intervention and supportive care, most patients with Del-C will complete the week and emerge from the acute hospital with normal mental status and function. Patients with Del-C who are very active and able to follow instructions tend to make a good recovery. For patients with Del-C, the use of an algorithm for detecting agitation on admission and the evaluation of agitation on a daily basis should help guide care management and intervention, especially in the outpatient setting.

Anonymous Patient Answer

What causes delirium?

This paper defines delirium in a modern medical emergency setting and describes some of the many causes of delirium, especially in the elderly. More is needed to understand and reduce the risk of delirium after a trauma.

Anonymous Patient Answer

What are the signs of delirium?

The four studied clinical signs all reflect some underlying mechanism of the acute state that precedes delirium. None, however, can be used as a diagnostic criterion to identify delirium in the absence of a clinical assessment, given the sensitivity and specificity of the clinical signs.

Anonymous Patient Answer

What are common treatments for delirium?

Common psychiatric treatments include antipsychotic medications, benzodiazepines (such as diazepam), mood stabilizers, antidepressants, anticonvulsants, or mood stabilizers in combination with an antidepressant. The use of benzodiazepines and psychotropic medications (such as antipsychotics, antidepressants, and anxiolytics) is a safety concern to patients and healthcare team members. The risks, benefits, and management differ depending on the cause of delirium and comorbidities.\n\nMany types of complementary and alternative medicine are used in health care. Many CAM therapies may be considered safe but have risks; many have never been adequately studied to determine the safety or efficacy.

Anonymous Patient Answer

What is delirium?

When used as a standalone term (delirium), it is a non-specific and vague term; when used with other concepts (i.e., a diagnosis of delirium), it is specific and precise.

Anonymous Patient Answer

How many people get delirium a year in the United States?

Around 60% of hospitalized patients will develop delirium. This makes it the most common cause of mental status changes among hospitalized people in the United States.

Anonymous Patient Answer

Is slow tempo music typically used in combination with any other treatments?

Compared to a slow tempo, an accelerating tempo reduces agitation in the ED without affecting the level of agitation in the intensive care unit. More importantly, slow tempo music may decrease stress from stressful activities in the ED.

Anonymous Patient Answer

What are the common side effects of slow tempo music?

Although participants reported no side effects during the slow tempo music sessions, the results showed a tendency toward more sleep disturbances and emotional symptoms as the session progressed. There were no significant differences in sleep duration, REM sleep, or stage 1 NREM sleep between slow tempo, fast tempo, and silence conditions.

Anonymous Patient Answer

How serious can delirium be?

[Delusions/hallucinations were the most common (21%) mental health problems encountered in this group of older medical inpatients at night.] Psychiatric in-patient service should have the skills to recognise and treat (correctly and promptly) delirium.

Anonymous Patient Answer

Does delirium run in families?

More precise genetic determinants of delirium are needed. The current results do not identify any common genetic determinants for psychotic symptoms. Future research should also examine other environmental, lifestyle, and psychosocial factors that may contribute to delirium occurrence.

Anonymous Patient Answer
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