The Effect Of Music On Compliance Of Patients İn COVİD-19 Intensive Care Unit With CPAP Device

Sponsor
SÜMEYYE BİLGİLİ (Other)
Overall Status
Recruiting
CT.gov ID
NCT05102084
Collaborator
Ataturk University (Other)
35
1
2
6
5.8

Study Details

Study Description

Brief Summary

Continuous Positive Airway Pressure (CPAP) therapy. It reduces the oxygen need of the patients, improves the prognosis of the patient, in the intensive care unit and shortens hospital stay. CPAP application in patients who need respiratory support. It improves respiratory mechanism and gas exchange, reduces respiratory workload and improves the prognosis of patients. However, the inconsistency between the breathing rhythm of the device and the patient's spontaneous breathing rhythm and pushing the oxygen into the patient's airways with high positive pressure causes the patient to worry and panic. and may lead to refusal of treatment. Relief of the patient for successful application of CPAP and device compatibility required. Music decreases adrenergic activity, decreases neuromuscular arousal. It is a universal language that causes decline. The rhythms of the human body harmonize with the melody and rhythms of the music. The data of this study, which was planned as an experimental and randomized control group, September -December Between 2021 It will be collected in the Covid Intensive Care Unit at Fethi Sekin City Hospital in Elazig. In this study, the effect of listening to music on patients' CPAP compliance will be investigated. CPAP compliance blood pressure, pulse and respiratory rate, Oxygen Saturation, Tidal Volume (mL), Total Respiratory Pressure (cmH20), Air Leak Monitoring (L/min) will be assessed with the Richmond agitation sedation scale (RASS). Covid-19 patients No study was found that investigated the effect of listening to music on adapting to the CPAP device. With this aspect, the work is unique. if the results from the study support the working hypothesis in reducing CPAP non-compliance in intensive care units. Success of treatment by listening to music can increase, The results of the research will be published in an international journal to contribute to the literature.

Condition or Disease Intervention/Treatment Phase
  • Device: Listening to music with a bluetooth headset to patients receiving CPAP support
N/A

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 increases the patient's CPAP compliance.

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 universe of the research was carried out at Fethi Sekin City Hospital in Elazig between September and December 2021. It will consist of patients who are inpatient in the Intensive Care Unit and need CPAP support. This in the study, a priori power analysis was performed to determine the sample size. In the power analysis Cohen's standard effect sizes reference method was chosen. In the power analysis he study was at a significance level of 0.05 at a 95% confidence interval and 80% in the high effect size range to reach the power it was determined that at least 52 people, 26 in each group, should be reached. Study inclusion criteria were met in order for the power to be over 80% and to meet the parametric conditions. 30 patients will be included in each suitable group and data will be collected until a total of 60 patients are reached.

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 Design

Study Type:
Interventional
Anticipated Enrollment :
35 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Effect Of Music On Compliance Of Patients İn COVİD-19 Intensive Care Unit With CPAP Device
Actual Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Patient follow-up form [30 minutes]

    Patient follow-up form systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate and oxygen saturation, Tidal Volume, total respiratory pressure, amount of air leakage values are checked. Using the patient's helper respiratory muscles, claustrophobia, anxiety and fear of death status evaluated. How many times did the patient touch the mask for 30 minutes? It is a form in which variables such as .

Secondary Outcome Measures

  1. Patient Information Form [30 minutes]

    In the patient introduction form developed by the researcher; patient's diagnosis, age, gender, weight, height, level of education, marital status, day of stay in intensive care, how many hours she took CPAP, Glasgow Coma Scale score, Richmond Agitation-Sedation Scale Score, including there are questions about patients, consisting of a total of nine questions.

  2. Glasgow Coma Scale (GCS) [30 minutes]

    GCS has been the basis of brain functions since 1974 and coma severity it is a valid scoring system used to determine. Eye opening, verbal and motor response 3 main functions are evaluated and scored. If the total score is 13-15 points the patient is awake, between 8-12 if precoma a score of 8 or less is considered coma

  3. Richmond Agitation-Sedation Scale (RASS): [30 minutes]

    Developed by Cook and Palma (1989) Sessler It is a scale introduced by (2002). Validity and reliability in Turkey by Sılay (2017) study has been done. RASS is a 10 point scale and their scores range from +4 to -5. Positive RASS scores indicate agitated patient, negative RASS scores refer to sedated or comatose patients. RASS +4 bad temper (at a level that may be dangerous for personnel), +3 too agitated (tube and catheter suffers, aggressive patient), +2 Agitated (frequent aimless movements, incompatibility with ventilator), +1 Restless (anxious but not aggressive), 0 being alert and calm, -1 Sleepy (short eye-opening with audible stimulus), -2 Lightweight sedation (short eye opening with audible stimulus), -3 Moderate sedation (eye-opening but eye contact cannot be installed), -4 Deep sedation (no response to audible stimulus, eye opening with physical stimulus), 5 Cannot Be Awakened is scored as.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ataturk University Erzurum Turkey 25240

Sponsors and Collaborators

  • SÜMEYYE BİLGİLİ
  • Ataturk University

Investigators

  • Principal Investigator: Reva Balcı Akpınar, Prof. dr, https://avesis.atauni.edu.tr/reva

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
SÜMEYYE BİLGİLİ, Nursing Fundamentals Graduate Student, Ataturk University
ClinicalTrials.gov Identifier:
NCT05102084
Other Study ID Numbers:
  • AU-SBİLGİLİ_001
First Posted:
Nov 1, 2021
Last Update Posted:
Nov 5, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by SÜMEYYE BİLGİLİ, Nursing Fundamentals Graduate Student, Ataturk University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 5, 2021