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

NCT05102084 | Completed

• 1 other identifier: AU-SBİLGİLİ_001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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).

Conditions

COVID-19; COVID-19 Acute Respiratory Distress Syndrome

Keywords

Covid-19; Cpap; Adapt; listen to music

Outcome Measures

Primary Outcomes (2)

• Changes in agitation level

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

  30 minutes

• Compliance with CPAP

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

  30 minutes

Secondary Outcomes (1)

• Variation of agitation and CPAP compliance with time

  30 minutes

Study Arms (2)

Experimental group

EXPERIMENTAL

Patients listening to music during CPAP application

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

Control group

NO INTERVENTION

Patients not listening to music during CPAP application

Interventions

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.

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SÜMEYYE BİLGİLİ: lead
• Ataturk University: collaborator

Study Sites (1)

Ataturk University

Erzurum, 25240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19; Microcephaly, Primary Autosomal Recessive, 6

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Reva Balcı Akpınar, Prof. Dr

  https://avesis.atauni.edu.tr/reva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Nursing Fundamentals Graduate Student

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: November 1, 2021
• Study Start: September 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: May 26, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)