Pain Clinical Trial
Official title:
The Effect of Music on Delirium, Pain, Need of Sedation, Anxiety and Vital Parameters in Patients Receiving Ventilator Support in Intensive Care
Verified date | October 2021 |
Source | Ege University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 37 |
Est. completion date | October 2021 |
Est. primary completion date | September 14, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Ege University | Izmir |
Lead Sponsor | Collaborator |
---|---|
Ege University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Length of ICU stay | The total days of ICU stay. | During ICU stay (from randomization until ICU discharge, or death, or 1 year follow-up) | |
Other | Duration of mechanical ventilation | The total days of mechanical ventilation. | During ICU stay (from randomization until ICU discharge, or death, or 1 year follow-up) | |
Other | 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. | During ICU stay (from randomization until ICU discharge, or death, or 1 year follow-up) | |
Primary | 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). | Date of study enrollment through 12 months. | |
Secondary | 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. | 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization | |
Secondary | 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. | 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization | |
Secondary | 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. | 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization | |
Secondary | 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. | 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization | |
Secondary | Systolic/diastolic blood pressure | Changes in the systolic/diastolic blood pressure (mm/Hg). Blood pressure was recorded from monitor of patient. | 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization | |
Secondary | Heart rate | Changes in the heart rate. Heart rate was measured as number of heartbeats in a per minute from monitor of patient. | 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization | |
Secondary | Respiratory rate | Changes in the respiratory rate. Respiratory rate was measured as number of breaths in a per minute from monitor of patient. | 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization | |
Secondary | Oxygen saturation | Changes in the oxygen saturation. Saturation was recorded from monitor of patient. | 2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization |
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