Anxiety, Delirium, Intensive Care Unit Delirium, Music, Pain, Sedation
Conditions
Keywords
delirium, intensive care, music
Brief summary
The purpose of this study is to test the effect of a twice daily, 60-minute, nurse initiated, music listening intervention on patients followed in the ICU with MV support as compared to patients who receive care as usual and ear plugs.
Detailed description
Delirium is an acute disorder of consciousness and cognitive function that occurs frequently in critical care settings. Many critically ill patients (e.g., up to 80% of patients) experience ICU delirium due to underlying medical or surgical health problems, recent surgical or other invasive procedures, medications, or various noxious stimuli (e.g., underlying psychological stressors, mechanical ventilation \[MV\], noise, light, patient care interactions, and drug-induced sleep disruption or deprivation). Delirium contributes to adverse outcomes such as increased mortality and morbidity, longer length of ICU stays, prolonged MV, costlier hospitalizations, and cognitive impairment after hospital discharge. The Society of Critical Care Medicine (SCMM) Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU (PADIS) recommend non-pharmacological interventions of preventing delirium and other symptoms. Music, which is one of the non-pharmacological applications, is one of the cognitive-behavioral treatment methods applied in the field of ICU as in many other fields. Music is easy method to apply and has no side effects and contributes to physical, psychological, emotional and spiritual healing. In the literature, it is seen that music intervention studies applied to patients followed in the ICU mostly focus on the effects on anxiety, pain, non-invasive ventilation tolerance, and stress response (heart rate, blood pressure, respiratory rate). The relationship between intensive care delirium and all these symptoms (pain, agitation, anxiety, stress response, etc.) and their interaction with each other have been clarified in the light of evidence-based guidelines and studies. Therefore, the aim of this study is to examine the effects of music applied to patients followed in the ICU with MV support on delirium, pain, need for sedation, anxiety and vital parameters.
Interventions
OTHERMusic
Music medicine
OTHEREarplug
Earplug with noise cancelling
Sponsors
Ege University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* ≥18 years, * Admitted to the ICU as of the start of the study and planned to be followed up in the ICU for at least 24 hours, * Needing invasive MV for at least 24 hours, * Pre-deliric score \> 20% * At least one positive delirium according to CAM-ICU, * GCS score \> 8, * RASS score ≥ -3, * Hemodynamically stable, * CPOT score ≥ 3
Exclusion criteria
* Hearing or vision problems, * Diagnosed with psychiatric illness, * Diagnosed with dementia, * Having acute neurological injury, * Alcohol/drug poisoning * Hemodynamically unstable and treated with high-dose inotropic/vasopressor medication, * Pregnant, * Planned to be followed in ICU for less than 24 hours, * Does not need MV, * GCS score ≤ 8, * RASS score \< -3, * Patients referred from another ICU
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delirium | Date of study enrollment through 12 months. | The delirium event assessed twice daily by trained research nurse using the CAM-ICU. The diagnosis of delirium is based on the presence of two major criteria (i.e. acute or fluctuating onset plus lack of attention) and at least one of the minor criteria (disorganized thinking or altered consciousness level). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety level | 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization | Anxiety level assessed by trained research nurse using Face Anxiety Scale. The scale is composed of five face types. The face type in the left-hand corner indicates an absence of anxiety, while anxiety increases towards the faces in the right-hand corner. When patient scores were three or above, their anxiety was determined to be medium to high. |
| Heart rate | 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization | Changes in the heart rate. Heart rate was measured as number of heartbeats in a per minute from monitor of patient. |
| Respiratory rate | 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization | Changes in the respiratory rate. Respiratory rate was measured as number of breaths in a per minute from monitor of patient. |
| Oxygen saturation | 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization | Changes in the oxygen saturation. Saturation was recorded from monitor of patient. |
| Delirium severity | 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization | In case of positive delirium, its severity assessed twice daily by trained research nurse using the CAM-ICU-7. CAM-ICU-7 is a seven point scale (0-7), derived from the RASS and the CAM-ICU. |
| Pain severity | 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization | Pain assessed by trained research nurse utilizing the Critical Care Pain Observation Tool (CPOT) a valid and reliable instrument in critically ill patients with and without delirium. The CPOT has 4 components: facial expression, body movements, muscle tension, and compliance with the ventilator for intubated patients or vocalization for extubated patients. Each component is scored from 0 to 2 with a possible total score ranging from 0 to 8. A CPOT ≥ 3 is indicative of significant pain. |
| Need of sedation | 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization | Sedation level assessed by trained research nurse using the Richmond Agitation-Sedation Scale (RASS). It is a ranking scale with 10-level (+4 combative to -5 unarousable) used to measure the agitation or sedation level of a person. |
| Systolic/diastolic blood pressure | 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization | Changes in the systolic/diastolic blood pressure (mm/Hg). Blood pressure was recorded from monitor of patient. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Delirium duration | During ICU stay (from randomization until ICU discharge, or death, or 1 year follow-up) | The delirium duration will be calculated when the patient is first considered to have delirium to the last time that patient is not supposed to have delirium based on CAM-ICU. |
| Duration of mechanical ventilation | During ICU stay (from randomization until ICU discharge, or death, or 1 year follow-up) | The total days of mechanical ventilation. |
| Length of ICU stay | During ICU stay (from randomization until ICU discharge, or death, or 1 year follow-up) | The total days of ICU stay. |
Countries
Turkey (Türkiye)
Outcome results
None listed