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

Not Applicable

Completed

• Conditions: COVID-19; COVID-19 Acute Respiratory Distress Syndrome
• Interventions: Device: Listening to music with a bluetooth headset to patients receiving CPAP support

• Registration Number: NCT05102084
• Lead Sponsor: SÜMEYYE BİLGİLİ

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2021-10-20
• Study First Submitted QC: 2021-10-20
• Study First Posted: 2021-11-01
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-25
• Last Update Posted: 2023-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Listening to music with a bluetooth headset to patients receiving CPAP support	Patients listening to music during CPAP application

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Variation of agitation and CPAP compliance with time	30 minutes	Measurements were made before CPAP, at 1st, 15th and 30th minutes of CPAP.

Trial Locations

Locations (1)

Ataturk University; 🇹🇷 Erzurum, Turkey