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

Primary Purpose

COVID-19, COVID-19 Acute Respiratory Distress Syndrome

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Listening to music with a bluetooth headset to patients receiving CPAP support
Sponsored by
SÜMEYYE BİLGİLİ
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for COVID-19 focused on measuring Covid-19, Cpap, Adapt, listen to music

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 11 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 11 will not be included in the study.

Sites / Locations

  • Ataturk University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

Patients listening to music during CPAP application

Patients not listening to music during CPAP application

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 20, 2021
Last Updated
May 25, 2023
Sponsor
SÜMEYYE BİLGİLİ
Collaborators
Atatürk University
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1. Study Identification

Unique Protocol Identification Number
NCT05102084
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
SÜMEYYE BİLGİLİ
Collaborators
Atatürk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, COVID-19 Acute Respiratory Distress Syndrome
Keywords
Covid-19, Cpap, Adapt, listen to music

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Patients listening to music during CPAP application
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients not listening to music during CPAP application
Intervention Type
Device
Intervention Name(s)
Listening to music with a bluetooth headset to patients receiving CPAP support
Intervention Description
Listening to music with a bluetooth headset during the CPAP application to the patients and checking the compatibility on the CPAP device.
Primary Outcome Measure Information:
Title
Changes in agitation level
Description
The agitation levels of patients were monitored with the Richmond Agitation and Sedation Scale
Time Frame
30 minutes
Title
Compliance with CPAP
Description
Measure of respiratory rate, oxygen saturation,mask air leakage amount
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Variation of agitation and CPAP compliance with time
Description
Measurements were made before CPAP, at 1st, 15th and 30th minutes of CPAP.
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reva Balcı Akpınar, Prof. Dr
Organizational Affiliation
https://avesis.atauni.edu.tr/reva
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ataturk University
City
Erzurum
ZIP/Postal Code
25240
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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