The Effect of Listening to Music During CPAP on the Agitation Levels and Compliance.

Study Overview
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Brief Summary
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Aim: This study was conducted to determine the effect of listening to music during CPAP on the agitation levels of intensive care patients who underwent CPAP due to COVID-19 and their compliance with the treatment. Study Design: This study is a prospective, randomized, controlled clinical trial. Seventy-six intensive care patients with COVID-19 were included in this study and assigned to the music and control groups via the block randomization method. The study was completed with 70 patients. In this study, the patients and outcome assessors were not blinded. The Richmond Agitation and Sedation Scale (RASS) level, respiratory rate, oxygen saturation (SpO2), and mask air leakage amount were the result criteria. Results: The mean RASS score of the patients in the intervention group was 2.14±0.69 before CPAP, 1.63±064 at the 1st minute, 0.89±0.58 at the 15th minute, and 0.74±0.61 at the 30th minute. The mean RASS score of the patients in the control group was 2.06±0.53 before CPAP, 1.80±0.58 at the 1st minute, 1.43±0.60 at the 15th minute, and 1.46±0.61 at the 30th minute of CPAP. There was a statistically significant difference between the groups at the 15th and 30th minutes (t=-3.81, p < .001; t=-4.89, p < .001, respectively).

Official Title
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The Effect of Listening to Music During CPAP on the Agitation Levels and Compliance With CPAP of Intensive Care Patients With COVID-19: A Randomized Controlled Trial

Conditions
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COVID-19, COVID-19 Acute Respiratory Distress Syndrome

Intervention / Treatment
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* Device: Listening to music with a bluetooth headset to patients receiving CPAP support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: over 18 years old Received CPAP treatment for 1 day in the intensive care unit, Not hearing impaired, No sedation treatment Not diagnosed with a psychiatric illness, Hemodynamically stable, Not taking drugs (such as digoxin, adrenaline, dopamine) that affect blood pressure and pulse rate Patients with a Glasgow Coma Scale score of 14 and above will be accepted. Exclusion Criteria: The patient's desire to leave the study be under the age of 18 putting the patient on mechanical ventilation have a hearing impairment Receiving sedation therapy diagnosed with psychiatric illness Using drugs (such as digoxin, adrenaline, dopamine) that affect blood pressure and pulse rate Patients with a Glasgow Coma Scale score below 14 will not be included in the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Patients listening to music during CPAP application | Device: Listening to music with a bluetooth headset to patients receiving CPAP support<br>* Listening to music with a bluetooth headset during the CPAP application to the patients and checking the compatibility on the CPAP device.<br>|
| No Intervention: Control group<br>Patients not listening to music during CPAP application | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in agitation level | The agitation levels of patients were monitored with the Richmond Agitation and Sedation Scale | 30 minutes | 
| Compliance with CPAP | Measure of respiratory rate, oxygen saturation,mask air leakage amount | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of agitation and CPAP compliance with time | Measurements were made before CPAP, at 1st, 15th and 30th minutes of CPAP. | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Covid-19, Cpap, Adapt, listen to music