NCT05514574已完成不适用
The Effect of Listening to Music and Stress Ball Application on Patients' Anxiety Level and Hemodynamic Parameters During Percutaneous Coronary Intervention
Keriman Yildiz2 个研究点 分布在 1 个国家目标入组 183 人开始时间: 2022年8月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 183
- 试验地点
- 2
- 主要终点
- State Anxiety Score
研究概览
简要总结
In this study, it was aimed to determine the effects of listening to music and applying a stress ball on patients' anxiety level and hemodynamic parameters during percutaneous coronary intervention (PCI).
详细描述
Percutaneous coronary intervention causes patients to experience anxiety and change their hemodynamic parameters. In this study, it was aimed to determine the effects of listening to music and applying a stress ball on patients' anxiety level and hemodynamic parameters during percutaneous coronary intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Patients and their relatives, clinical staff, will be blinded to the group assignment. Evaluation of the data will be done by a blinded technique by a biostatistician not involved in the study and blinded to group assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years and older,
- •Literate,
- •Able to communicate verbally,
- •Turkish speaking,
- •No hearing or vision loss,
- •No sensory or motor deficits in the hand or arm,
- •Percutaneous coronary intervention will be applied,
- •intervention from the femoral artery,
- •Voluntarily participated in the research,
- •Patients signing the informed consent form will be included.
排除标准
- •Under the age of 18,
- •Not signing the informed consent form,
- •Illiterate,
- •Unable to speak Turkish,
- •Unable to communicate verbally
- •Those who have a neurological or psychiatric disease that prevents communication,
- •Hearing and sight impaired,
- •Those who have had a mastectomy
- •Those with arterio-venous fistula
- •Percutaneous coronary intervention has been performed in the last 2 years,
- •Restricted special groups (pregnant women, criminal convicts, etc.),
- •Emergency cases where communication cannot be established,
- •Those with equipment problems such as monitors and cuffs,
- •Those who will be given sedatives during the procedure,
- •Those who will be taking cardiovascular system medications other than routine practices during the procedure,
- •Those who will be given oxygen during the procedure,
- •Patients who are treated from a different artery other than the femoral artery will not be accepted.
- •Criteria for exclusion from follow-up:
- •Those who want to quit working,
- •Those who give up listening to music,
- •Those who give up using the stress ball,
- •Those who were given cardiovascular system medications other than routine practices during the procedure,
- •Those who underwent intervention from a different artery instead of the femoral artery,
- •Those who do not want to wear headphones because they cannot hear the doctor's questions
- •Those whose second measurements could not be taken because they were quickly removed from the interventional room,
- •Those who underwent carotid artery angiography in addition to coronary artery,
- •Those who give incorrect PCI history,
- •Those who cannot listen to music or whose music is interrupted due to connection problems,
- •Those whose intervention cannot be performed at the planned time due to urgent patient arrival,
结局指标
主要结局
State Anxiety Score
时间窗: Each participant's State Anxiety score will be measured before and after admission to (twice-daily) the percutaneous coronary intervention room will be followed for 1 day (day of the attempt) will be recorded in the data collection form.
Change in State Anxiety Score after intervention.
次要结局
- Systolic Blood Pressure Value (mmHg)(Systolic Blood Pressure value of each participant will be measured in the pre- and post-procedure (twice-daily) in percutaneous coronary intervention room will be followed for 1 day (day of the attempt) will be recorded in the data collection form)
- Diastolic Blood Pressure Value (mmHg)(Diastolic Blood Pressure value of each participant will be measured in the pre- and post-procedure (twice-daily) in percutaneous coronary intervention room will be followed for 1 day (day of the attempt) will be recorded in the data collection form.)
- Heart Rate/Minute Value(Heart Rate/Minute value of each participant will be measured in the pre- and post-procedure (twice-daily) in percutaneous coronary intervention room will be followed for 1 day (day of the attempt) will be recorded in the data collection form.)
- Respiratory Rate/Minute Value(Respiratory Rate/Minute value of each participant will be measured in the pre- and post-procedure (twice-daily) in percutaneous coronary intervention room will be followed for 1 day (day of the attempt) will be recorded in the data collection form.)
- Peripheral Oxygen Saturation (SpO2) Value(Peripheral Oxygen Saturation value of each participant will be measured in the pre- and post-procedure (twice-daily) in percutaneous coronary intervention room will be followed for 1 day (day of the attempt) will be recorded in the data collection form.)
- Mean Arterial Pressure Value (mmHg)(Mean Arterial Pressure value of each participant will be measured in the pre- and post-procedure (twice-daily) in percutaneous coronary intervention room will be followed for 1 day (day of the attempt) will be recorded in the data collection form.)
研究者
Keriman Yildiz
Study Director
Necmettin Erbakan University
研究点 (2)
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