Clinical trial NCT05102084: The Effect of Listening to Music During CPAP on the Agitation Levels and Compliance.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
COVID-19 Acute Respiratory Distress Syndrome
Keywords: Covid-19
Cpap
Adapt
listen to music
Lead sponsor: Ataturk University
Sponsor class: OTHER
Collaborators: name: Ataturk University
First posted: 2021-11-01
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in agitation level
timeFrame: 30 minutes
measure: Compliance with CPAP
timeFrame: 30 minutes
Secondary outcomes:
measure: Variation of agitation and CPAP compliance with time
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
Study officials:
affiliation: https://avesis.atauni.edu.tr/reva
name: Reva Balcı Akpınar, Prof. Dr
role: PRINCIPAL_INVESTIGATOR
References: