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临床试验/NCT06300294
NCT06300294已完成不适用

The Effect of Acupressure on Anxiety And Physiological Parameters in Individuals Diagnosed With Acute Coronary Syndrome: A Randomized Controlled Study

Abant Izzet Baysal University2 个研究点 分布在 2 个国家目标入组 68 人开始时间: 2024年5月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
68
试验地点
2
主要终点
means of blood pressure

研究概览

简要总结

This study aims to examine the effect of acupressure on physiological parameters and anxiety levels in individuals diagnosed with Acute Coronary Syndrome (ACS).

H1-1: Acupressure applied to individuals with ACS has an effect on blood pressure.

H1-2: Acupressure applied to individuals with ACS has an effect on heart rate. H1-3: Acupressure applied to individuals with ACS has an effect on respiratory rate.

H1-4: Acupressure applied to individuals with ACS has an effect on pain levels. H1-5: Acupressure applied to individuals with ACS has an effect on anxiety levels.

H1-6: Acupressure applied to individuals with ACS has an effect on cortisol levels.

H1-7: Acupressure applied to individuals with ACS has an effect on ECG changes.

详细描述

Acute Coronary Syndrome (ACS) affects millions of people every year; It refers to three types of coronary artery disease: unstable angina pectoris, non-ST-elevation myocardial infarction (NSTE MI) and ST-elevation myocardial infarction (STEMI). It is known that 19 million people in the world and 161 thousand people in our country lost their lives due to Cardiovascular Disease (CVD). Approximately 3 million people worldwide die due to STEMI.Individuals experiencing ACS generally; It is observed that he/she experiences burning, stinging and compressive chest pain, tachycardia, sweating, fatigue, dizziness, dyspnea, nausea, anxiety and depression.Management of the disease is combined with pharmacological applications; It is tried to be provided with non-pharmacological applications such as education, acupuncture and acupressure. When the literature is examined, acupressure application; in the physiological parameters of individuals with myocardial infarction; It brings blood pressure, heart rate and respiratory rate to normal limits, and increases oxygen saturation and sleep quality; It appears to reduce anxiety and pain.For all these reasons, this study aims to examine the effect of acupressure on physiological parameters (blood pressure, heart rate, respiratory rate, pain and cortisol) and anxiety levels in individuals diagnosed with ACS.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

The study protocol was developed using SPIRIT guidelines. Research reporting was structured according to the CONSORT checklist. To prevent selection bias in this study, participants were randomly assigned to intervention and control groups using block randomization. Because the researcher was also the administrator, blinding was not possible. However, the use of block randomization maintained balance between groups and prevented the prediction of group information in the early stages of the study. In this context, the researcher and the participants were blinded to their assignment to the group during the initial data collection process. Furthermore, to maintain objectivity during the data analysis process, the data analyst was not informed of the group assignments. All data were entered into the analysis program as "Group 1" and "Group 2," thus preventing any bias based on information.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Volunteer to participate in the study,
  • Those aged 18 and over
  • Able to speak Turkish
  • Diagnosed with ACS for the first time
  • Cardiopulmonary resuscitation not applied
  • No orientation problems (those who score 15 on the Glasgow Coma Scale)
  • Not diagnosed with psychiatric disease
  • No amputation, fistula, lymphedema, neuropathy or hemiplegia in any of the Upper Extremities
  • Those who underwent femoral intervention for CAG procedure
  • Those who have not used any integrative practices based on pressure and stimulation such as acupressure, acupuncture and reflexology in the last month.
  • Vital signs (28) are within normal range:
  • Blood pressure: 90/60-120/80 mmHg Heart rate: 60-100 min Respiratory rate: 12-18 min

排除标准

  • Those with arrhythmia (AF, VT etc.)
  • Patients who have previously undergone Coronary Angiography
  • Diagnosed with myocarditis, pericarditis
  • Those who do not take any speed-breaking drugs (beloc, arlec, etc.).
  • Patients who underwent radial intervention for CAG procedure

研究组 & 干预措施

acupressure

Experimental

acupressure application and Routine care and treatment (filling out the initial hospitalization documents, measuring vital signs, taking an ECG, preparing for the CAG procedure, administering the ordered medications).

干预措施: acupressure (Other)

control

No Intervention

Routine care and treatment (filling out the initial hospitalization documents, measuring vital signs, taking an ECG, preparing for the CAG procedure, administering the ordered medications).

结局指标

主要结局

means of blood pressure

时间窗: up to 30 minutes

In this study, blood pressure was measured using monitors in the intensive care unit.

means of hear rate

时间窗: up to 30 minutes

Heart rate is the pressure exerted on the vessel wall by the blood thrown by the left ventricle from the skin surface to the aorta during systole. In the research, heart rate is measured using a monitor.

means of respiratory rate

时间窗: up to 30 minutes

Respiratory rate is the patient's breaths per minute. In this study, respiratory rate was taken from the monitor.

means of cortisol.

时间窗: up to 60 minutes

The cortisol value in the blood will be measured.

次要结局

  • means of subjective anxiety scores.(up to 30 minutes)
  • means of subjective pain scores.(up to 30 minutes)
  • electrocardiography evaluation(up to 30 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Saadet Can Çiçek

ASSOCIATE PROFESSOR DOCTOR

Abant Izzet Baysal University

研究点 (2)

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