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

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).

Study Overview

• Status: Completed
• Conditions: COVID-19; COVID-19 Acute Respiratory Distress Syndrome
• Intervention / Treatment: Device: Listening to music with a bluetooth headset to patients receiving CPAP support

Detailed Description

Literature Review:

The subject of this research is mechanical ventilation in intensive care with pneumonia caused by Covid-19 it is aimed at ensuring compliance of patients receiving support with the application of CPAP. for this purpose, it was aimed to investigate the effect of listening to music. In CPAP application, positive pressure oxygen is applied to the patient with a mask. With the breathing rhythm of the device, inconsistency between the patient's spontaneous respiratory rhythm and high oxygen with positive pressure pushing the patient into the airways, conscious patient's fear, anger, anxiety, and panic to live and may lead to refusal of treatment. In this research, music listening will be used to synchronize the rhythm of the device and the patient's breathing rhythm and to facilitate the adaptation of patients to the device. CPAP compliance of the patient's arterial blood pressure, pulse and respiratory rate, oxygen saturation, tidal volume (mL) Total Respiratory Pressure (cmH20), monitoring of air leakage (l/min), Richmond agitation sedation scale (RASS) will be assessed. With music, adrenergic activity and neuromuscular stimulation can be reduced. Thus, heart rate, respiratory rate and blood pressure decrease. vital signs of patients such as pulse rate, respiratory rate harmonizes with the melody and rhythm of the music. The effect of music, sound made up of waves depends on the number of vibrations (pitch) and the number of beats per minute (tempo). Loud voice curtain acts as a psychological stressor and stimulating the sympathetic nervous system heart rate, respiration, and blood pressure is raising. low pitched fixed, slow and repetitive rhythms by stimulating the parasympathetic nervous system it is known to have a relaxing and relaxing effect. music for relaxation, in a regular rhythm (60-80 per minute) should be should not be excessively loud and active, fluent, calming like violin, flute, piano soothing sound should provide.

Music used in nursing care practices and nursing research non-drug one of the methods. Nurses benefit from the physiological and psychological effects of musical sounds able to solve the nursing problem. In studies conducted in recent years; health care procedures with music that there is a close relationship between, can be used in all areas of health, painless, safe, inexpensive, no side effects it is stated that it is a treatment method. Adaptation to the CPAP device effect of music a limited number of studies have been found that show. Smith et al. In 2009; Obstructive Sleep Apnea Syndrome of patients diagnosed they investigated the effect of listening to music on compliance with CPAP treatment. study 53 men it was realized with the participation of 44 female patients. Patients receiving CPAP therapy a every night before going to sleep a voice played with the band. In the results of working It was found that listening to music had a beneficial effect on compliance with CPAP at 1 month but improving CPAP use and more extensive research to strengthen long-term compliance explained that you need.

Original Value:

Due to pneumonia due to COVID-19 patients receiving mechanical ventilation support in intensive care to the CPAP device has difficulty adapting. Covid-19 patients facilitating adaptation to the CPAP device music listening effectively no research has been found. In this aspect, the work is unique.

Research Hypothesis:

H1: Listening to music during CPAP reduces agitation level of intensive care patients with COVID-19.

H2: Listening to music during CPAP increase compliance to CPAP of intensive care patients with COVID-19.

Widespread Effect:

CPAP in intensive care units if the results from the study support the working hypothesis the success of the treatment can be increased by listening to music to reduce the incompatibility of the patients. This situation is related to COVID 19 reduction of related complications, reduction in hospitalization costs, early discharge and patient it will help increase your comfort. Publishing the research results in an international journal with the announcement, it will be used by intensive care nurses all over the world.

Method:

Type of Research: Research is of experimental type Characteristics and Date of the Research Place: The data of the research are between July - December 2021 betweeni t will be collected in the Covid Intensive Care Unit at Fethi Sekin City Hospital in Elazig. This the number of intensive care units and beds varies according to the course of the number of Covid-19 cases and the need in the hospital along with showing 1-10 intensive care units are in service, the number of hospitalizations per day is between 4-30 is changing. There are 12-13 beds in each intensive care unit and a maximum of 10 patients can be admitted to a unit is done. All patient rooms in the intensive care unit are single occupancy. the physical structure of the room, its temperature, lighting is similar and ventilation system is negative pressure. The intense work the duration of CPAP to be applied to the patients in the care is determined by the doctor's request and should be at least 30 minutes is implemented.

The universe of the research and the sample:

The population of the research consisted of patients with COVID-19 who were hospitalized in the intensive care unit of the city hospital and underwent CPAP. A priori power analysis was performed to determine the sample size of the study. It was found that 78 patients should be recruited at the 0.05 significance level and 95% confidence interval for an effect in the medium-high effect size range (According to Cohen, an effect size of 0.65 (0.5+0.8/2) corresponding to this range was chosen).

Determination of Experimental and Control Group:

Inpatients in the intensive care unit at the same hours every day (between 18 and 22 in the evening) and being included in the study. Experiment and control with the "easy randomization" method by determining the patients who meet the criteria will be assigned to the group. Until the determined number is reached by taking a maximum of 2 experimental and 2 control groups every day data collection will continue until.

Music Listening to be used:

A recommendation was received from the Turkish Music Research and Promotion Group for the piece of music to be played. Music therapist and voice artist Andrea Azize Güvenç, from her music archive, for patients who underwent CPAP he compiled 4 music tracks of 30 minutes in total in a relaxing and appropriate rhythm. in music the sounds and instruments used are as follows:

1. Müzik: Su - Dombra - Ses,
2. Music: Su - Kopuz
3. Music: Su- Tambourine - Sound
4. Music: Water - Dombra - Sound These 4 tracks have been combined as a single sound recording and will be played to the patients in sequence without interruption.

Bluetooth MP3 Player : The music tracks will be loaded into a digital, portable LCD 4GB rechargeable MP3 music player Bluetooth Headset: The music will be played with over-the-ear, full size, bluetooth, rechargeable headphones.

Dependent Variables: Systolic blood pressure, diastolic blood pressure, pulse rate and respiratory rate of the patients, oxygen Saturation Value, Tidal Volume (mL), Total Respiratory Pressure (cmH20), Air Leak Monitoring (L/min) are Richmond agitation sedation scale (RASS) scores.

Independent variables: : Music concert

Application:

The researcher will visit the intensive care unit at 18-22 pm everyday during this visit wearing protective equipment will prevent transmission. Patients meeting the inclusion criteria will be determined and assigned to the experimental or control group by randomization. For the patient included in the experimental group determined by randomization, patient Identification Form before CPAP is administered systolic blood pressure, diastolic blood pressure, pulse rate and respiratory rate RASS scores will be determined and recorded by observation. with CPAP application music concert will start with the help of ear and systolic blood at the 1st, 15th and 30th minutes of administration pressure, diastolic blood pressure, pulse rate and respiratory rate from the patient monitor, RASS scores will be recorded again by observation, 1st, 15th and 30th min Oxygen Saturation Value with CPAP, Tidal Volume (mL), Total Respiratory Pressure (cmH20), Air Leak Monitoring (L/min) by CPAP monitor will be saved. The pressure and oxygen settings of the CPAP are determined by the doctor according to the patient's need will be set. Questions to be answered by the patient regarding the application will be asked before and after the application. If the patient will continue to receive CPAP, the observation will be terminated and CPAP will continue. Music the concert will be played with a Blueooth MP3 player and Bluetooth headphones. Headphones from every use then it will be disinfected, the Mp3 player is in a disposable plastic bag to prevent contamination the patient will be taken to the room. CPAP application without music will be applied to the control group and pre-CPAP, CPAP during the application, the same measurements will be made at the 1st minute, 15th minute and 30th minute. In intensive care silicone masks are used in CPAP application. Mask size is according to the patient's face size will be set.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sümeyye Bilgili; Phone Number: +90 506 175 93 71; Email: smeyyebilgili@gmail.com
• Study Contact Backup: Name: Reva Balcı Akpınar, Prof. dr; Phone Number: 0442 231 22 14 +90 532 717 31 55; Email: reva@atauni.edu.tr

Study Locations

• Turkey
  • Erzurum, Turkey, 25240
    • Ataturk University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Patients listening to music during CPAP application	Device: Listening 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.
No Intervention: Control group; Patients not listening to music during CPAP application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: SÜMEYYE BİLGİLİ
• Collaborators: Ataturk University
• Investigators: Principal Investigator: Reva Balcı Akpınar, Prof. Dr, https://avesis.atauni.edu.tr/reva

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: October 20, 2021
• First Submitted That Met QC Criteria: October 20, 2021
• First Posted (Actual): November 1, 2021

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Covid-19; Cpap; Adapt; listen to music
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; COVID-19; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: AU-SBİLGİLİ_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No