COVID-19NCT05102084
The Effect of Listening to Music During CPAP on the Agitation Levels and Compliance.
A study testing Listening to music with a bluetooth headset to patients receiving CPAP support in people with COVID-19 and COVID-19 Acute Respiratory Distress Syndrome, run by SÜMEYYE BİLGİLİ at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, COVID-19 Acute Respiratory Distress Syndrome
- What is being tested?
- Listening to music with a bluetooth headset to patients receiving CPAP support
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
- Being tested
- Listening to music with a bluetooth headset to patients receiving CPAP support
- Keywords
- Covid-19, Cpap, Adapt, listen to music
- Medical subject headings
- COVID-19, Microcephaly, Primary Autosomal Recessive, 6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Listening to music with a bluetooth headset to patients receiving CPAP supportDevice
Listening to music with a bluetooth headset during the CPAP application to the patients and checking the compatibility on the CPAP device.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patients listening to music during CPAP application Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in agitation level
The agitation levels of patients were monitored with the Richmond Agitation and Sedation Scale
Measured: 30 minutes
Compliance with CPAP
Measure of respiratory rate, oxygen saturation,mask air leakage amount
Measured: 30 minutes
Secondary outcomes (1)
Variation of agitation and CPAP compliance with time
Measurements were made before CPAP, at 1st, 15th and 30th minutes of CPAP.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start1 Sep 2021
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- SÜMEYYE BİLGİLİ
- Sponsor type
- University, hospital or other
- Collaborators
- Ataturk University
- Responsible party
- Sponsor-investigator, SÜMEYYE BİLGİLİ, Ataturk University
- Investigators
- Reva Balcı Akpınar, Prof. Dr, Principal investigator, https://avesis.atauni.edu.tr/reva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05102084
- Sponsor's protocol ID
- AU-SBİLGİLİ_001
- Status last verified
- May 2023
- First submitted
- 20 Oct 2021
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05102084
- Acronym / sponsor ID
- AU-SBİLGİLİ_001
- Keywords
- Covid-19, Cpap, Adapt, listen to music
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- SÜMEYYE BİLGİLİUniversity, hospital or other
- Collaborators
- Ataturk University
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 1 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Listening to music with a bluetooth headset to patients receiving CPAP supportPatients listening to music during CPAP application |
| Control group | No intervention | –Patients not listening to music during CPAP application |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Listening to music with a bluetooth headset to patients receiving CPAP supportListening to music with a bluetooth headset during the CPAP application to the patients and checking the compatibility on the CPAP device. | Device | Experimental group |
Primary outcome
Changes in agitation level
Time frame: 30 minutes
The agitation levels of patients were monitored with the Richmond Agitation and Sedation Scale
Compliance with CPAP
Time frame: 30 minutes
Measure of respiratory rate, oxygen saturation,mask air leakage amount
1 secondary outcome
Variation of agitation and CPAP compliance with time
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reva Balcı Akpınar, Prof. Dr principal investigator
https://avesis.atauni.edu.tr/reva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Listening to music with a bluetooth headset to patients receiving CPAP support in people with COVID-19 and COVID-19 Acute Respiratory Distress Syndrome, run by SÜMEYYE BİLGİLİ at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in agitation level (time frame: 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2023.