Sleep QualityAnxiety SleepNCT07454434
The Effect of Music on Anxiety Levels and Sleep Quality in Patients Who Have a Myocardial Infarction
A study testing Music intervention in people with Sleep Quality and Anxiety, run by Mersin University.
Trial summary
Music therapy is a non-invasive method with no side effects and can be administered independently by a nurse. Nevertheless, it should be noted that music therapy can be discontinued if any adverse effects are experienced by patients during the research process. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality, Anxiety
- What is being tested?
- Music intervention
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 23 Feb 2026to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Admitted to the coronary care unit with a diagnosis of MI,
- Aged 18 years or older,
- Conscious, oriented, and cooperative,
- Able to read and understand Turkish,
- Agreeing to participate in the study,
- Having no physical condition that would prevent listening to music,
Show all 14Show fewer
- Having no diagnosis of hearing loss,
- Not using a hearing aid,
- Having no diagnosis of anxiety disorder,
- Not diagnosed with a sleep disorder,
- Not taking medication for anxiety or sleep disorders,
- Without mental illness,
- With a State Anxiety Scale (SAS) total score of 60 or below,
- Who agree to participate in the study (by signing the Informed Consent Form) will be included.
Who cannot join
- Admitted to the coronary care unit (CCU) for reasons other than MI diagnosis,
- Under 18 years of age,
- Unconscious, disoriented, and uncooperative,
- Unable to read and understand Turkish,
- Refusing to participate in the study,
- Having a physical condition that prevents listening to music,
Show all 13Show fewer
- Diagnosed with hearing loss,
- Using a hearing aid,
- Diagnosed with an anxiety disorder or taking medication for anxiety,
- Diagnosed with a sleep disorder or taking medication for a sleep disorder,
- With a mental disorder,
- With a State Anxiety Scale (SAS) total score of 60 or above,
- Patients who do not agree to participate in the study (who do not sign the Informed Consent Form) will not be included in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Music on Anxiety Levels and Sleep Quality During the First Night in the Coronary Care Unit in Patients Who Have a Myocardial Infarction
Music therapy is a non-invasive method with no side effects and can be administered independently by a nurse. Nevertheless, it should be noted that music therapy can be discontinued if any adverse effects are experienced by patients during the research process. After completing the music listening session, eye masks and earplugs, which are effective in reducing sleep problems in patients, will be applied from 11:00 p.m. to 7:00 a.m.
All patients will be asked to complete the DAÖ at 10:00 PM and 10:30 PM. The RCUÖ will be requested to be completed by all patients between 8:00 AM and 9:00 AM the following morning.
Read the detailed description
Control Group: Patients in the control group will receive routine treatment and care in the coronary care unit (CCU). Patients presenting with MI are admitted to the coronary care unit from the emergency department and the cardiology outpatient clinic. In patients admitted to the CCU, preparations are made for percutaneous coronary intervention (PCI) and admission procedures by evaluating electrocardiography (ECG), blood parameters (CK-MB and troponin), and pain symptoms. These preparations include obtaining the patient's medical history and necessary consent, establishing an intravenous line, measuring and monitoring vital signs, and recording the ECG and adding it to the file. In patients undergoing PCI, the femoral sheath is not removed for four hours due to the heparin infusion administered. After the femoral sheath is removed by the physician, pressure dressing is applied to the procedure site and a sandbag is placed to control bleeding for six hours. During this time, patients are placed in a supine position. Depending on the clinical condition and hematological values of the patients, they are monitored in the coronary care unit for one or two days and then transferred to the cardiology clinic.
In the coronary care unit, in order to control patients' anxiety levels or improve their sleep quality, after care, treatment, and daily blood sampling procedures are completed, lighting is reduced after midnight, except in emergencies, to facilitate patients' transition to sleep. However, eye masks or earplugs are not routinely used for patients.
Study Group: In addition to the clinic's routine treatment and care practices, patients in the study group will listen to music for 30 minutes at 10:00 p.m. on their first night in the coronary care unit using wireless Bluetooth headphones (JBL TUNE 520BT, Harman International Industries, USA) provided by the researcher (MY). The volume of the music will be adjusted according to the patient's preference. Patients in the study will listen to the CD "Music and Health Series: Tümata-Receptive \& Meditative Uşşak Mode" prepared by the Turkish Music Research and Promotion Association (TÜMATA), which is said to provide calmness and relaxation and has previously been shown to be effective in reducing preoperative anxiety. The Uşşak mode has a tempo of 60-80 beats per minute and provides relaxation by calming the heart. The CD used contains an instrumental piece without lyrics in the Uşşak mode, which fits the definition of "sedative music". The piece features improvisation based on rhythm and the sound of water, performed with the ney, rebab, çeng, ud, dombra, and rubab. In addition to evoking a sense of peace and tranquility, the Uşşak mode supports feelings of self-confidence and determination thanks to its hidden pentatonic structure . The Uşşak mode is reported to give individuals a desire to laugh, a feeling of relaxation, joy, strength, and heroism; it is also reported to be beneficial for sleep and rest processes. Its effect is said to be particularly pronounced from dawn to noon, at sunset, and on Thursdays; it is also said to be beneficial in alleviating pain associated with heart and foot disorders and gout. Furthermore, it is known as one of the oldest modes used to express deep love and mystical feelings .
- Conditions
- Sleep Quality, Anxiety
- Being tested
- Music intervention
- Keywords
- music listening, nursing, sleep, anxiety
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music interventionOther
Music therapy is a non-invasive method with no side effects and can be administered independently by a nurse. However, it should be noted that music therapy may be discontinued if any adverse effects are observed in patients during the research process. After completing the music therapy, eye masks and earplugs , which are effective in reducing sleep problems in patients, will be applied from 11:00 p.m. to 7:00 a.m.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control Group: Patients in the control group will receive routine treatment and care in the coronary care unit (CCU). Patients with MI are admitted to the coronary care unit from the emergency department and the cardiology outpatient clinic. In patients admitted to the care unit, preparations are made for percutaneous coronary intervention (PCI) and admission procedures by evaluating electrocardiography (ECG), blood parameters (CK-MB and Troponin), and pain symptoms. These preparations include obtaining the patient's medical history and necessary consent, establishing an intravenous line, measuring and monitoring vital signs, and recording the ECG and adding it to the file. In patients undergoing PCI, the femoral sheath is not removed for four hours due to the heparin infusion administered. After the femoral sheath is removed by the physician, pressure dressing is applied to the procedure site and a sandbag is placed to control bleeding for six hours. During this time, patients are pl |
| Music Group | Experimental | Patients included in the study group will be played music at 10:00 PM on their first night in the Coronary Care Unit (CCU) for 30 minutes using wireless Bluetooth headphones (JBL TUNE 520BT, Harman International Industries, USA) by the researcher (MY), in addition to the clinic's routine treatment and care practices. The volume of the music will be adjusted according to the patient's preference. Patients in the study will listen to the CD "Music and Health Series: Tümata-Receptive \& Meditative Uşşak Mode" from the Turkish Music Research and Promotion Association (TÜMATA), which is said to provide calmness and relaxation and has previously been shown to be effective in reducing preoperative anxiety . The Uşşak mode has a tempo of 60-80 beats per minute and provides relaxation by calming the heart . The CD used contains an instrumental piece without lyrics in the Uşşak mode, which fits the definition of "sedative music" . The piece features improvisation based on rhythm Receives: Other: Music intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants' anxiety levels
In this study, the State-Trait Anxiety Inventory (STAI) developed by Spielberger and colleagues will be used to measure feelings experienced at the moment. The adaptation of the State-Trait Anxiety Inventory into Turkish, as well as its validity and reliability studies, were conducted by Öner and Le Comte. The scale consists of the SSI, which determines how an individual feels at a particular moment and under specific conditions, and the State Anxiety Scale (SAS), which determines how an individual feels regardless of their current situation and conditions. State anxiety is the fear felt by an individual due to stressful situations they are in and is an indicator of the individual's feelings of tension and unease . The response options in the SSI are grouped into four classes: (1) Not at all, (2) A little, (3) Very much, and (4) Completely. There are two types of statements in the SAD. These are (1) direct or straightforward and (2) reverse statements.
Measured: Within the State Anxiety Scale framework, the study group will receive 30 minutes of music at 22:00 on their first night in the Coronary Intensive Care Unit, alongside routine care, via wireless Bluetooth headphones under researcher supervision.
Secondary outcomes (1)
Sleep Quality
In this study, the RCUÖ , developed by Richards in 1987, will be used to measure the sleep quality of patients during their first night in the coronary care unit. The scale consists of 6 items that assess the depth of nighttime sleep, the time it takes to fall asleep, the frequency of waking up, the time spent awake after waking up, the quality of sleep, and the noise level in the environment.
Each item is evaluated using the visual analog scale technique, on a scale from 0 to 100. On the scale, scores between "0-25" indicate very poor sleep, while scores between "76-100" indicate very good sleep. The sixth item on the scale, which assesses environmental noise, is excluded from the total score assessment, and the total scale score is calculated based on the five items. As the scale score increases, patients' sleep quality improves. The Cronbach α value of the original scale was found to be 0.82, and the Turkish validity and reliability study was conducted by Karaman
Measured: The Richard-Campbell Sleep Questionnaire will be administered to all patients between 08:00 and 09:00 on the morning following their first night of hospitalization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start23 Feb 2026 (estimated)
- Primary completion15 Mar 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- 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
- Model description
- Single blind
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meryem Yesil, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07454434
- Sponsor's protocol ID
- MersinUniversit
- Other IDs
- Gülay Altun Ugras
- Acronym
- Anxiety Sleep
- Status last verified
- Mar 2026
- First submitted
- 10 Dec 2025
- Last updated
- 6 Mar 2026
- 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 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music on Anxiety Levels and Sleep Quality During the First Night in the Coronary Care Unit in Patients Who Have a Myocardial Infarction
- ClinicalTrials.gov ID
- NCT07454434
- Acronym / sponsor ID
- Anxiety Sleep / MersinUniversit
- Conditions
- Sleep Quality, Anxiety
- Keywords
- music listening, nursing, sleep, anxiety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 23 Feb 2026 (estimated)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 6 Mar 2026 (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.
Music therapy is a non-invasive method with no side effects and can be administered independently by a nurse. Nevertheless, it should be noted that music therapy can be discontinued if any adverse effects are experienced by patients during the research process. After completing the music listening session, eye masks and earplugs, which are effective in reducing sleep problems in patients, will be applied from 11:00 p.m. to 7:00 a.m.
All patients will be asked to complete the DAÖ at 10:00 PM and 10:30 PM. The RCUÖ will be requested to be completed by all patients between 8:00 AM and 9:00 AM the following morning.
Detailed description
Control Group: Patients in the control group will receive routine treatment and care in the coronary care unit (CCU). Patients presenting with MI are admitted to the coronary care unit from the emergency department and the cardiology outpatient clinic. In patients admitted to the CCU, preparations are made for percutaneous coronary intervention (PCI) and admission procedures by evaluating electrocardiography (ECG), blood parameters (CK-MB and troponin), and pain symptoms. These preparations include obtaining the patient's medical history and necessary consent, establishing an intravenous line, measuring and monitoring vital signs, and recording the ECG and adding it to the file. In patients undergoing PCI, the femoral sheath is not removed for four hours due to the heparin infusion administered. After the femoral sheath is removed by the physician, pressure dressing is applied to the procedure site and a sandbag is placed to control bleeding for six hours. During this time, patients are placed in a supine position. Depending on the clinical condition and hematological values of the patients, they are monitored in the coronary care unit for one or two days and then transferred to the cardiology clinic.
In the coronary care unit, in order to control patients' anxiety levels or improve their sleep quality, after care, treatment, and daily blood sampling procedures are completed, lighting is reduced after midnight, except in emergencies, to facilitate patients' transition to sleep. However, eye masks or earplugs are not routinely used for patients.
Study Group: In addition to the clinic's routine treatment and care practices, patients in the study group will listen to music for 30 minutes at 10:00 p.m. on their first night in the coronary care unit using wireless Bluetooth headphones (JBL TUNE 520BT, Harman International Industries, USA) provided by the researcher (MY). The volume of the music will be adjusted according to the patient's preference. Patients in the study will listen to the CD "Music and Health Series: Tümata-Receptive \& Meditative Uşşak Mode" prepared by the Turkish Music Research and Promotion Association (TÜMATA), which is said to provide calmness and relaxation and has previously been shown to be effective in reducing preoperative anxiety. The Uşşak mode has a tempo of 60-80 beats per minute and provides relaxation by calming the heart. The CD used contains an instrumental piece without lyrics in the Uşşak mode, which fits the definition of "sedative music". The piece features improvisation based on rhythm and the sound of water, performed with the ney, rebab, çeng, ud, dombra, and rubab. In addition to evoking a sense of peace and tranquility, the Uşşak mode supports feelings of self-confidence and determination thanks to its hidden pentatonic structure . The Uşşak mode is reported to give individuals a desire to laugh, a feeling of relaxation, joy, strength, and heroism; it is also reported to be beneficial for sleep and rest processes. Its effect is said to be particularly pronounced from dawn to noon, at sunset, and on Thursdays; it is also said to be beneficial in alleviating pain associated with heart and foot disorders and gout. Furthermore, it is known as one of the oldest modes used to express deep love and mystical feelings .
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single blind
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control Group: Patients in the control group will receive routine treatment and care in the coronary care unit (CCU). Patients with MI are admitted to the coronary care unit from the emergency department and the cardiology outpatient clinic. In patients admitted to the care unit, preparations are made for percutaneous coronary intervention (PCI) and admission procedures by evaluating electrocardiography (ECG), blood parameters (CK-MB and Troponin), and pain symptoms. These preparations include obtaining the patient's medical history and necessary consent, establishing an intravenous line, measuring and monitoring vital signs, and recording the ECG and adding it to the file. In patients undergoing PCI, the femoral sheath is not removed for four hours due to the heparin infusion administered. After the femoral sheath is removed by the physician, pressure dressing is applied to the procedure site and a sandbag is placed to control bleeding for six hours. During this time, patients are pl |
| Music Group | Experimental | Other: Music interventionPatients included in the study group will be played music at 10:00 PM on their first night in the Coronary Care Unit (CCU) for 30 minutes using wireless Bluetooth headphones (JBL TUNE 520BT, Harman International Industries, USA) by the researcher (MY), in addition to the clinic's routine treatment and care practices. The volume of the music will be adjusted according to the patient's preference. Patients in the study will listen to the CD "Music and Health Series: Tümata-Receptive \& Meditative Uşşak Mode" from the Turkish Music Research and Promotion Association (TÜMATA), which is said to provide calmness and relaxation and has previously been shown to be effective in reducing preoperative anxiety . The Uşşak mode has a tempo of 60-80 beats per minute and provides relaxation by calming the heart . The CD used contains an instrumental piece without lyrics in the Uşşak mode, which fits the definition of "sedative music" . The piece features improvisation based on rhythm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Admitted to the coronary care unit with a diagnosis of MI,
- Aged 18 years or older,
- Conscious, oriented, and cooperative,
- Able to read and understand Turkish,
- Agreeing to participate in the study,
Key exclusion criteria (13 listed)
- Admitted to the coronary care unit (CCU) for reasons other than MI diagnosis,
- Under 18 years of age,
- Unconscious, disoriented, and uncooperative,
- Unable to read and understand Turkish,
- Refusing to participate in the study,
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 |
|---|---|---|
| Music interventionMusic therapy is a non-invasive method with no side effects and can be administered independently by a nurse. However, it should be noted that music therapy may be discontinued if any adverse effects are observed in patients during the research process. After completing the music therapy, eye masks and earplugs , which are effective in reducing sleep problems in patients, will be applied from 11:00 p.m. to 7:00 a.m. | Other | Music Group |
Primary outcome
Participants' anxiety levels
Time frame: Within the State Anxiety Scale framework, the study group will receive 30 minutes of music at 22:00 on their first night in the Coronary Intensive Care Unit, alongside routine care, via wireless Bluetooth headphones under researcher supervision.
In this study, the State-Trait Anxiety Inventory (STAI) developed by Spielberger and colleagues will be used to measure feelings experienced at the moment. The adaptation of the State-Trait Anxiety Inventory into Turkish, as well as its validity and reliability studies, were conducted by Öner and Le Comte. The scale consists of the SSI, which determines how an individual feels at a particular moment and under specific conditions, and the State Anxiety Scale (SAS), which determines how an individual feels regardless of their current situation and conditions. State anxiety is the fear felt by an individual due to stressful situations they are in and is an indicator of the individual's feelings of tension and unease . The response options in the SSI are grouped into four classes: (1) Not at all, (2) A little, (3) Very much, and (4) Completely. There are two types of statements in the SAD. These are (1) direct or straightforward and (2) reverse statements.
1 secondary outcome
Sleep Quality
Time frame: The Richard-Campbell Sleep Questionnaire will be administered to all patients between 08:00 and 09:00 on the morning following their first night of hospitalization.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Music intervention in people with Sleep Quality and Anxiety, run by Mersin University.
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 14 inclusion and 13 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: opening soon, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meryem YEŞİL, Master Degree (05074373163, meryemsag@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants' anxiety levels (time frame: Within the State Anxiety Scale framework, the study group will receive 30 minutes of music at 22:00 on their first night in the Coronary Intensive Care Unit, alongside routine care, via wireless Bluetooth headphones under researcher supervision.). 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 6 Mar 2026.