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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (30 minutes before angiography), during angiography (at the time of catheter insertion), and 15 minutes after completion of the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (30 minutes before angiography), during angiography (at the time of catheter insertion), and 15 minutes after completion of the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dilara Yıldızoğlu, MSc | Yuksek Ihtısas University Faculty of Health Sciences, Nursing Department | Principal Investigator |
| Arzu Aydoğan, Assistant Professor | Yuksek Ihtısas University Faculty of Health Sciences, Nursing Department | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yuksek Ihtısas University | Ankara | 06790 | Turkey (Türkiye) |
IPD will not be shared to protect participant privacy and confidentiality.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 25, 2025 | Feb 6, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 3, 2025 | Feb 6, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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.
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No parties are masked in this study. Both the participants and the investigators are aware of the intervention. The study is conducted as an open-label trial.
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|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D001523 | Mental Disorders |