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NCT Number: NCT05102084

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

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).

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Key information

Conditions

COVID-19 COVID-19 Acute Respiratory Distress Syndrome Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Microcephaly, Primary Autosomal Recessive, 6 Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ataturk University

Erzurum, 25240, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Listening to music with a bluetooth headset to patients receiving CPAP support

Device

Listening to music with a bluetooth headset during the CPAP application to the patients and checking the compatibility on the CPAP device.

Primary outcomes

  1. Changes in agitation level

    Time frame: 30 minutes

    The agitation levels of patients were monitored with the Richmond Agitation and Sedation Scale

  2. Compliance with CPAP

    Time frame: 30 minutes

    Measure of respiratory rate, oxygen saturation,mask air leakage amount

Secondary outcomes

  1. Variation of agitation and CPAP compliance with time

    Time frame: 30 minutes

    Measurements were made before CPAP, at 1st, 15th and 30th minutes of CPAP.

Sponsors and collaborators

Lead sponsor

SÜMEYYE BİLGİLİ

Other

Collaborators

  • Ataturk University

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 1, 2021
Registry last updated
May 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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