- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07424339
The Effect of Music Played During the Angiography Procedure on Patients' Anxiety Levels and Vital Signs
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey (Türkiye), 06790
- Yuksek Ihtısas University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged between 18 and 65 years
- Literate patients
- Patients who voluntarily agree to participate in the study
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Music Therapy Group
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.
|
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.
|
|
No Intervention: Control Group
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline (30 minutes before angiography), during angiography (at the time of catheter insertion), and 15 minutes after completion of the procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dilara Yıldızoğlu, MSc, Yuksek Ihtısas University Faculty of Health Sciences, Nursing Department
- Study Director: Arzu Aydoğan, Assistant Professor, Yuksek Ihtısas University Faculty of Health Sciences, Nursing Department
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- YIU-NURS-ANGIO-MUSIC-2026-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coronary Artery Disease
-
Infirmerie Protestante de LyonRecruitingCoronary Artery Bypass | Coronary Artery Disease(CAD) | Off Pump Coronary Artery Bypass Surgery | Hemodynamic Optimization | Hemodynamic Management | Off Pump Coronary Artery Bypass Graft | Coronary Artery Disease With Need for Bypass Surgery | NoradrenalineFrance
-
Shanghai Bluesail Boyuan Medical Technology Co....Not yet recruitingCoronary Artery Disease | Coronary Artery Calcification | Severe Coronary Artery DiseaseChina
-
I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioCompletedCoronary Artery Disease (CAD) | Atherosclerosis of Coronary ArteryItaly
-
Scitech Produtos Medicos SANot yet recruitingCoronary Artery Disease (CAD) | Multivessel Coronary Artery Disease | Complex Coronary Lesions | Calcific Coronary Arteriosclerosis | Small Vessel Ischemic Disease | Stenosis CoronaryBrazil
-
Istanbul Mehmet Akif Ersoy Educational and Training...Bakirkoy Dr. Sadi Konuk Research and Training Hospital; Ege University; Istanbul... and other collaboratorsActive, not recruitingCoronary Artery Disease (CAD) | Coronary Bifurcation Lesion | Left Main Coronary Artery StenosisTurkey (Türkiye)
-
University Medical Centre LjubljanaRecruitingCoronary Artery Disease With Myocardial InfarctionSlovenia
-
EBI Anti Sepsis BVCR2O B.V.Not yet recruitingCoronary Artery Disease (CAD) | Coronary Artery Bypass Graft Surgery(CABG)United States, Netherlands, Belgium, United Kingdom
-
Mahidol UniversityThe Princess Mantarop Kamalas Foundation, The Nurses' Association of Thailand and other collaboratorsActive, not recruitingCoronary Artery Disease (CAD) | Postoperative Recovery | Coronary Artery Bypass Graft (CABG)Thailand
-
Fundación EPICActive, not recruitingCoronary Artery Disease | Left Main Coronary Artery Disease | Left Main Coronary Artery Stenosis | Restenosis, CoronarySpain
-
Elixir Medical CorporationIstituto Clinico HumanitasActive, not recruitingCoronary Artery Disease | Chronic Total Occlusion of Coronary Artery | Multi Vessel Coronary Artery Disease | Bifurcation of Coronary Artery | Long Lesions Coronary Artery DiseaseItaly
Clinical Trials on Music intervention
-
Da-Yeh UniversityNot yet recruitingAnxiety | Blood Pressure | Heart Rate | Heart Rate Variability (HRV)
-
Guangzhou First People's HospitalActive, not recruiting
-
Nigde Omer Halisdemir UniversityCompletedDental Anxiety | Pain Perception | Fissure Sealant | Dental Procedures | Pediatric Dental PatientsTurkey (Türkiye)
-
Universidade da MadeiraRecruitingHealth People | Survivors of StrokePortugal
-
Toronto Metropolitan UniversityMitacsActive, not recruitingStress, Psychological | Loneliness | Emotion Regulation | Well Being | Executive Functions | Functional AbilitiesCanada
-
Alanya Alaaddin Keykubat UniversityAnkara UniversityCompleted
-
Universidad Miguel Hernandez de ElcheCompletedCardiovascular Diseases | Emergencies | Critical Care | Music Therapy
-
University of Alabama at BirminghamCompleted
-
University Diego PortalesRecruiting
-
Azienda Unita Sanitaria Locale di PiacenzaNot yet recruitingPain | Blood Pressure | Music Therapy | Heart Rate | NursingItaly