An interventional study of Music and Earplug in Delirium, Pain and Sedation, sponsored by Ege University. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-10-19.
Sponsored by Ege University · Not applicable, Interventional, and Prevention
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.
1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.
This study's planned enrollment of 37 is below the median of 120 across 599 interventional studies indexed under Delirium.
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Exclusion Criteria:
"MusiCure®" compositions specially composed for the music group will be performed twice a day, between 10.00-11.00 a.m. and 14.00-15.00 p.m., for five days with headphones and a music player. Before the application, the sound level of the ICU environment will be measured with a decibel meter. At the 0th minute of the music application, at the 30th minute after starting the music, and at the 60th minute after the end of the music, the characteristics of delirium, pain, sedation level, anxiety and vital parameters will be recorded with data collection tools.
Other: Music
In this group, patients will be given only earplugs. Before the application, the sound level of the ICU environment will be measured with a decibel meter. At the 0th minute of the intervention, at the 30th minute after starting intervention, and at the 60th minute after the end of the intervention, the characteristics of delirium, pain, sedation level, anxiety and vital parameters will be recorded with data collection tools.
Other: Earplug
The control group involves neither music intervention nor using earplug.
Music medicine
Earplug with noise cancelling
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.
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.
Time frame: 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization
Systolic/diastolic blood pressure
Changes in the systolic/diastolic blood pressure (mm/Hg). Blood pressure was recorded from monitor of patient.
Time frame: 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization
Heart rate
Changes in the heart rate. Heart rate was measured as number of heartbeats in a per minute from monitor of patient.
Time frame: 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization
Respiratory rate
Changes in the respiratory rate. Respiratory rate was measured as number of breaths in a per minute from monitor of patient.
Time frame: 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization
Oxygen saturation
Changes in the oxygen saturation. Saturation was recorded from monitor of patient.
Time frame: 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization
Length of ICU stay
The total days of ICU stay.
Time frame: During ICU stay (from randomization until ICU discharge, or death, or 1 year follow-up)
Duration of mechanical ventilation
The total days of mechanical ventilation.
Time frame: During ICU stay (from randomization until ICU discharge, or death, or 1 year follow-up)
Delirium duration
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.
Time frame: During ICU stay (from randomization until ICU discharge, or death, or 1 year follow-up)
Plan to share: Undecided
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Ege University