The Effect of Music Played During the Angiography Procedure on Patients' Anxiety Levels and Vital Signs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Anxiety levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 65 years
- •Literate patients
- •Patients who voluntarily agree to participate in the study
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Music intervention (Behavioral)
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.
结局指标
主要结局
Anxiety levels
时间窗: 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.
次要结局
- Vital Sign Level(Baseline (30 minutes before angiography), during angiography (at the time of catheter insertion), and 15 minutes after completion of the procedure)
研究者
Dilara Yıldızoğlu
Research Assistant
Yuksek Ihtisas University