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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05102084
Enrollment
70
Registered
2021-11-01
Start date
2021-09-01
Completion date
2021-12-01
Last updated
2023-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, COVID-19 Acute Respiratory Distress Syndrome

Keywords

Covid-19, Cpap, Adapt, listen to music

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).

Interventions

DEVICEListening 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.

Sponsors

Ataturk University
CollaboratorOTHER
SÜMEYYE BİLGİLİ
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Changes in agitation level30 minutesThe agitation levels of patients were monitored with the Richmond Agitation and Sedation Scale
Compliance with CPAP30 minutesMeasure of respiratory rate, oxygen saturation,mask air leakage amount

Secondary

MeasureTime frameDescription
Variation of agitation and CPAP compliance with time30 minutesMeasurements were made before CPAP, at 1st, 15th and 30th minutes of CPAP.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026