Coronary Artery DiseaseNCT07424339
The Effect of Music Played During the Angiography Procedure on Patients' Anxiety Levels and Vital Signs
A study testing Music intervention in people with Coronary Artery Disease, run by Dilara Yıldızoğlu at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study was conducted to determine the effect of music played during the angiography procedure on patients' anxiety levels and vital signs. Patients scheduled for angiography were randomly assigned to either a music intervention group or a control group receiving routine care. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Music intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Jun 2025to 15 Nov 2025
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 65 years
- Literate patients
- Patients who voluntarily agree to participate in the study
Who cannot join
- Clinically unstable patients
- Patients scheduled for emergency angiography
- Patients with hearing impairment
- Patients who have used any analgesic medication prior to the procedure
- Patients unable to communicate in Turkish
- Patients using anxiolytic or sedative medications
- Patients without a psychiatric diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
This randomized controlled study was conducted to determine the effect of music played during the angiography procedure on patients' anxiety levels and vital signs. Patients scheduled for angiography were randomly assigned to either a music intervention group or a control group receiving routine care. Anxiety levels were assessed using validated anxiety measurement tools, and vital signs including blood pressure, heart rate, and oxygen saturation were recorded at multiple time points before, during, and after the procedure. In the intervention group, selected music was played throughout the angiography procedure, while no music intervention was applied to the control group. This study evaluates the role of music as a non-pharmacological intervention for anxiety management during angiography.
Read the detailed description
This study was conducted to determine the effect of music played during the angiography procedure on patients' anxiety levels and vital signs. The study was designed as a quantitative, experimental, pretest-posttest randomized controlled trial. Stratified randomization was applied, and patients were assigned to groups according to risk factors including physician, gender, and age. The randomization process was carried out in accordance with the principle of probabilistic assignment using a computer-assisted randomization method.
The study was conducted between June 2025 and November 2025 with patients who applied to the cardiology outpatient clinic of a private hospital and were scheduled to undergo angiography. Research data were collected using a Personal Information Form, the Hospital Anxiety Subscale of the Hospital Anxiety and Depression Scale, the Distress Thermometer, and a Vital Signs Monitoring Form. All data collection forms were administered together with the informed consent form.
After preoperative electrocardiography recording, patients in both the experimental and control groups who met the inclusion criteria completed the Personal Information Form, the Hospital Anxiety Scale, and the Distress Thermometer. Vital signs were recorded using the Vital Signs Monitoring Form.
For patients in the experimental group, selected music was played via a wireless Bluetooth speaker throughout the angiography procedure after admission to the angiography unit and completion of standard preparations. Patients were informed that they could control the volume of the music, including increasing or decreasing the sound level, stopping the music, or restarting it if desired. Patients in the control group underwent the procedure according to the hospital's routine clinical workflow without any music intervention.
During the intraoperative period, anxiety levels of patients in both groups were assessed using the Distress Thermometer, and vital signs were recorded. Fifteen minutes after completion of the procedure, posttest assessments were performed by re-administering the Hospital Anxiety Scale and the Distress Thermometer, and vital signs were recorded again.
- Conditions
- Coronary Artery Disease
- Being tested
- Music intervention
- Keywords
- Anxiety, Vital Signs, Music, Coronary Angiography
- Medical subject headings
- Coronary Artery Disease, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music interventionBehavioural
This intervention differs from other clinical interventions because it involves passive music listening in the procedure room rather than formal therapy, drugs, or devices. Headphones are not used in order to avoid interfering with communication between the patient and healthcare staff. It is a non-therapeutic, behavioral intervention designed to assess its effect on anxiety and vital signs during angiography.
| Study group | Role | What they receive |
|---|---|---|
| Music Therapy Group | Experimental | Participants in this group will receive music therapy during the angiography procedure. Anxiety levels and vital signs will be measured before and after the procedure. Receives: Behavioral: Music intervention |
| Control Group | No intervention | Participants in this group will receive standard care without music therapy during the angiography procedure. Anxiety levels and vital signs will be measured before and after the procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety levels
Anxiety level assessed using the Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A; score range 0-21) and the Distress Thermometer (score range 0-10). Higher scores indicate greater anxiety/distress.
Measured: Baseline (30 minutes before angiography), during angiography (at the time of catheter insertion), and 15 minutes after completion of the procedure
Secondary outcomes (1)
Vital Sign Level
Heart rate (beats/min), systolic blood pressure (mmHg), diastolic blood pressure (mmHg), respiratory rate (breaths/min), and oxygen saturation (%) recorded using vital signs monitoring form.
Measured: Baseline (30 minutes before angiography), during angiography (at the time of catheter insertion), and 15 minutes after completion of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start13 Jun 2025
- Primary completion13 Nov 2025
- Study completion15 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a randomized controlled interventional study designed to evaluate the effect of music therapy during angiography on patients' anxiety levels and vital signs. Participants who meet the inclusion criteria will be randomly assigned to either the intervention group, which will receive music therapy during the procedure, or the control group, which will receive standard care without music. Baseline measurements of anxiety and vital signs will be taken before the procedure, and post-intervention measurements will be recorded immediately after the procedure. The primary outcome is the change in anxiety levels, while secondary outcomes include changes in heart rate, blood pressure, and other vital signs.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dilara Yıldızoğlu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dilara Yıldızoğlu, Yuksek Ihtisas University
- Investigators
- Dilara Yıldızoğlu, MSc, Principal investigator, Yuksek Ihtısas University Faculty of Health Sciences, Nursing DepartmentArzu Aydoğan, Assistant Professor, Study director, Yuksek Ihtısas University Faculty of Health Sciences, Nursing Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07424339
- Sponsor's protocol ID
- YIU-NURS-ANGIO-MUSIC-2026-01
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared to protect participant privacy and confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music Played During the Angiography Procedure on Patients' Anxiety Levels and Vital Signs
- ClinicalTrials.gov ID
- NCT07424339
- Acronym / sponsor ID
- YIU-NURS-ANGIO-MUSIC-2026-01
- Conditions
- Coronary Artery Disease
- Keywords
- Anxiety, Vital Signs, Music, Coronary Angiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Dilara YıldızoğluUniversity, hospital or other
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- 13 Nov 2025 (actual)
- Study completion
- 15 Nov 2025 (actual)
- First posted
- 20 Feb 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.
This randomized controlled study was conducted to determine the effect of music played during the angiography procedure on patients' anxiety levels and vital signs. Patients scheduled for angiography were randomly assigned to either a music intervention group or a control group receiving routine care. Anxiety levels were assessed using validated anxiety measurement tools, and vital signs including blood pressure, heart rate, and oxygen saturation were recorded at multiple time points before, during, and after the procedure. In the intervention group, selected music was played throughout the angiography procedure, while no music intervention was applied to the control group. This study evaluates the role of music as a non-pharmacological intervention for anxiety management during angiography.
Detailed description
This study was conducted to determine the effect of music played during the angiography procedure on patients' anxiety levels and vital signs. The study was designed as a quantitative, experimental, pretest-posttest randomized controlled trial. Stratified randomization was applied, and patients were assigned to groups according to risk factors including physician, gender, and age. The randomization process was carried out in accordance with the principle of probabilistic assignment using a computer-assisted randomization method.
The study was conducted between June 2025 and November 2025 with patients who applied to the cardiology outpatient clinic of a private hospital and were scheduled to undergo angiography. Research data were collected using a Personal Information Form, the Hospital Anxiety Subscale of the Hospital Anxiety and Depression Scale, the Distress Thermometer, and a Vital Signs Monitoring Form. All data collection forms were administered together with the informed consent form.
After preoperative electrocardiography recording, patients in both the experimental and control groups who met the inclusion criteria completed the Personal Information Form, the Hospital Anxiety Scale, and the Distress Thermometer. Vital signs were recorded using the Vital Signs Monitoring Form.
For patients in the experimental group, selected music was played via a wireless Bluetooth speaker throughout the angiography procedure after admission to the angiography unit and completion of standard preparations. Patients were informed that they could control the volume of the music, including increasing or decreasing the sound level, stopping the music, or restarting it if desired. Patients in the control group underwent the procedure according to the hospital's routine clinical workflow without any music intervention.
During the intraoperative period, anxiety levels of patients in both groups were assessed using the Distress Thermometer, and vital signs were recorded. Fifteen minutes after completion of the procedure, posttest assessments were performed by re-administering the Hospital Anxiety Scale and the Distress Thermometer, and vital signs were recorded again.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a randomized controlled interventional study designed to evaluate the effect of music therapy during angiography on patients' anxiety levels and vital signs. Participants who meet the inclusion criteria will be randomly assigned to either the intervention group, which will receive music therapy during the procedure, or the control group, which will receive standard care without music. Baseline measurements of anxiety and vital signs will be taken before the procedure, and post-intervention measurements will be recorded immediately after the procedure. The primary outcome is the change in anxiety levels, while secondary outcomes include changes in heart rate, blood pressure, and other vital signs.
| Arm | Type | Receives |
|---|---|---|
| Music Therapy Group | Experimental | Behavioral: Music interventionParticipants in this group will receive music therapy during the angiography procedure. Anxiety levels and vital signs will be measured before and after the procedure. |
| Control Group | No intervention | –Participants in this group will receive standard care without music therapy during the angiography procedure. Anxiety levels and vital signs will be measured before and after the procedure. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged between 18 and 65 years
- Literate patients
- Patients who voluntarily agree to participate in the study
Key exclusion criteria (7 listed)
- Clinically unstable patients
- Patients scheduled for emergency angiography
- Patients with hearing impairment
- Patients who have used any analgesic medication prior to the procedure
- Patients unable to communicate in Turkish
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 interventionThis intervention differs from other clinical interventions because it involves passive music listening in the procedure room rather than formal therapy, drugs, or devices. Headphones are not used in order to avoid interfering with communication between the patient and healthcare staff. It is a non-therapeutic, behavioral intervention designed to assess its effect on anxiety and vital signs during angiography. | Behavioural | Music Therapy Group |
Primary outcome
Anxiety levels
Time frame: Baseline (30 minutes before angiography), during angiography (at the time of catheter insertion), and 15 minutes after completion of the procedure
Anxiety level assessed using the Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A; score range 0-21) and the Distress Thermometer (score range 0-10). Higher scores indicate greater anxiety/distress.
1 secondary outcome
Vital Sign Level
Time frame: Baseline (30 minutes before angiography), during angiography (at the time of catheter insertion), and 15 minutes after completion of the procedure
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 20 Feb 2026.
- Individual participant dataSharing planned: No. IPD will not be shared to protect participant privacy and confidentiality.
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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.
Dilara Yıldızoğlu, MSc principal investigator
Yuksek Ihtısas University Faculty of Health Sciences, Nursing Department
Arzu Aydoğan, Assistant Professor study director
Yuksek Ihtısas University Faculty of Health Sciences, Nursing Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music intervention in people with Coronary Artery Disease, run by Dilara Yıldızoğlu 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 3 inclusion and 7 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 20 Feb 2026. 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?
Anxiety levels (time frame: Baseline (30 minutes before angiography), during angiography (at the time of catheter insertion), and 15 minutes after completion of the procedure). 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 20 Feb 2026.