Clinical trial NCT05082623: The Effect of Music on Delirium, Pain, Need of Sedation, Anxiety and Vital Parameters
Official title: The Effect of Music on Delirium, Pain, Need of Sedation, Anxiety and Vital Parameters in Patients Receiving Ventilator Support in Intensive Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Delirium
Pain
Sedation
Anxiety
Music
Intensive Care Unit Delirium
Keywords: delirium
intensive care
music
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2021-10-19
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Delirium
timeFrame: Date of study enrollment through 12 months.
Secondary outcomes:
measure: Delirium severity
timeFrame: 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization
measure: Pain severity
timeFrame: 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization
measure: Need of sedation
timeFrame: 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization
measure: Anxiety level
timeFrame: 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization
measure: Systolic/diastolic blood pressure
timeFrame: 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization
measure: Heart rate
timeFrame: 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization
measure: Respiratory rate
timeFrame: 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization
measure: Oxygen saturation
timeFrame: 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization
Other outcomes:
measure: Length of ICU stay
timeFrame: During ICU stay (from randomization until ICU discharge, or death, or 1 year follow-up)
measure: Duration of mechanical ventilation
timeFrame: During ICU stay (from randomization until ICU discharge, or death, or 1 year follow-up)
measure: Delirium duration
timeFrame: During ICU stay (from randomization until ICU discharge, or death, or 1 year follow-up)
Locations:
city: İzmir
country: Turkey
facility: Ege University
Study officials:
References: