The Effect of Music on Delirium, Pain, Need of Sedation, Anxiety and Vital Parameters

Ege University37 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Delirium Pain Sedation Anxiety Music Intensive Care Unit Delirium

Interventions

MusicOTHER

Music medicine

EarplugOTHER

Earplug with noise cancelling

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Ege University

Izmir, Turkey (Türkiye)

Outcomes

Primary Outcomes

Delirium

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).

Time frame: Date of study enrollment through 12 months.

Secondary Outcomes

Delirium severity

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.

Time frame: 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization

Pain severity

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.

Time frame: 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization

Need of sedation

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.

Time frame: 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization

Anxiety level

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.

Data from ClinicalTrials.gov

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