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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05102084
• Other study ID #: AU-SBILGILI_001
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: December 1, 2021

Study information

• Verified date: May 2023
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. over 18 years old

2. Received CPAP treatment for 1 day in the intensive care unit,

3. Not hearing impaired,

4. No sedation treatment

5. Not diagnosed with a psychiatric illness,

6. Hemodynamically stable,

7. Not taking drugs (such as digoxin, adrenaline, dopamine) that affect blood pressure and pulse rate

8. Patients with a Glasgow Coma Scale score of 14 and above will be accepted.

Exclusion Criteria:

1. The patient's desire to leave the study

2. be under the age of 18

3. putting the patient on mechanical ventilation

4. have a hearing impairment

5. Receiving sedation therapy

6. diagnosed with psychiatric illness

7. Using drugs (such as digoxin, adrenaline, dopamine) that affect blood pressure and pulse rate

8. Patients with a Glasgow Coma Scale score below 14 will not be included in the study.

Related Conditions & MeSH terms

• Acute Lung Injury
• COVID-19
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• Listening to music with a bluetooth headset to patients receiving CPAP support
Listening to music with a bluetooth headset during the CPAP application to the patients and checking the compatibility on the CPAP device.

Locations

Country	Name	City	State
Turkey	Ataturk University	Erzurum

Sponsors (2)

Lead Sponsor	Collaborator
SÜMEYYE BILGILI	Atatürk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in agitation level	The agitation levels of patients were monitored with the Richmond Agitation and Sedation Scale	30 minutes
Primary	Compliance with CPAP	Measure of respiratory rate, oxygen saturation,mask air leakage amount	30 minutes
Secondary	Variation of agitation and CPAP compliance with time	Measurements were made before CPAP, at 1st, 15th and 30th minutes of CPAP.	30 minutes