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临床试验/NCT06916351
NCT06916351已完成不适用

The Effect of Acupressure Applied Before Coronary Angiography on Pain, Anxiety and Vital Signs in Patients

Bandırma Onyedi Eylül University1 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2024年5月1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
发起方
入组人数
93
试验地点
1
主要终点
State-Trait Anxiety Scale (STAI)

研究概览

简要总结

This randomized controlled experimental study aimed to determine the effects of acupressure applied before the procedure on pain, anxiety and vital signs in patients who applied to Kocaeli City Hospital Angiography Unit and were to undergo planned radial artery coronary angiography.

详细描述

This randomized controlled experimental study was conducted at the Kocaeli City Hospital Angiography Unit to determine the effects of acupressure applied before coronary angiography on pain, anxiety and vital signs of the patients scheduled to undergo coronary angiography. It was conducted at the Kocaeli City Hospital Angiography Unit. The study used a stratified block randomization method and 93 patients who met the inclusion criteria were assigned to two different intervention groups, one of which received acupressure and the other a sham intervention before coronary angiography, and a control group receiving standard care. Data were collected using the 'Personal Information Form', 'State Anxiety Inventory (STAI)', 'Visual Analog Scale (VAS)' and 'Patient Follow-up Form'.

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
Single (Participant)

盲法说明

The participant does not know which group he/she is in.

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

  • •for the study
  • •Over 18 years of age,
  • •Able to understand and speak Turkish,
  • •Open to communication,
  • •First time undergoing radial artery coronary angiography,
  • •Elective patients undergoing planned (non-urgent) coronary angiography,
  • •Patients who did not undergo stent/balloon intervention during angiography,
  • •Awake and conscious during coronary intervention (not having taken sedatives (dormicum/fentanyl))
  • •No deformities or lesions in the areas where acupressure will be applied (hematoma, ecchymosis, etc.)
  • •Having not taken sedatives or painkillers 5 hours before the angiography,
  • •No experience with acupressure,
  • •No history of attending training courses and yoga classes to control stress and anxiety in the last six months
  • •No diagnosis of anxiety disorder and not receiving medical treatment
  • •No diagnosis of depression and not receiving medical treatment
  • •Flat on the back (patients without respiratory distress, etc.),
  • •Hemodynamically stable (no chest pain or arrhythmia),
  • •Patients who volunteer to participate in the study,

排除标准

  • •for the study
  • •Diagnosed with any psychiatric disease
  • •Previously undergone coronary angiography from the radial or femoral artery
  • •Chronic pain
  • •Used opioid medication
  • •CAG procedure to be performed from the femoral artery

研究组 & 干预措施

Sham acupressure

Placebo Comparator

Sham acupressure will be applied to three points parallel to HT7, LI4 and PC6, approximately 1-1.5 cm away from the meridians. To prepare the points for acupressure, these points will be rubbed for approximately 20-30 seconds without applying direct pressure, reducing tissue sensitivity. The researcher will then apply acupressure to these points and symmetrical points using the thumb for three minutes, but will apply less pressure than required levels. Similar to the acupressure group, preparations and acupressure application will take approximately 20 minutes in total for each patient.

干预措施: Sham acupressure (Other)

Control

No Intervention

Patients in the control group will not receive any intervention and will receive routine treatment and care.

Acupressure

Experimental

Acupressure will be applied to a total of three points, namely HT7, LI4, and PC6, determined by the researcher with a certificate according to literature and expert opinion before the CAG procedure for the acupressure group. The "cun" measurement unit will be used to determine the points where the application will be made. Before the application, after approximately 20-30 seconds of heating and rubbing without direct pressure on the acupressure points, the researcher will manually press the determined acupressure points with the thumb for 10 seconds to create a depth of 1-1.5 cm. Pressure will be applied to each acupressure point for three consecutive minutes (in the breathing rhythm) without lifting the finger, allowing for two seconds of relaxation. Since the symmetry of the three different points selected on the other extremity will also be applied, a total of 18 minutes of pressure will be applied to each point, with the condition of three minutes.

干预措施: Acupressure (Other)

结局指标

主要结局

State-Trait Anxiety Scale (STAI)

时间窗: Before acupressure application, 20 minutes after acupressure application (20 minutes after application in the sham acupressure group, 20 min. after the initial measurement in the control group), immediately after the CABG procedure, 2 and 4 hours later

The State-Trait Anxiety Scale (STAI) is a scale developed by Spielberger et al. in 1970. The STAI determines how an individual feels at a certain moment and under a certain condition. The Turkish adaptation of the STAI was made by Öner and Le Compte in 1983 and the Cronbach alpha coefficient was reported as 0.94 (Öner and Le Compte, 1985). The STAI consists of 20 questions on a four-point Likert type. The statements in the STAI are evaluated as not at all 1 point, a little 2 points, a lot 3 points and completely 4 points. In this section, the statements are divided into direct and reversed. The scale score varies between 20-80 and an increase in the score obtained from the scale indicates an increase in the anxiety level. A score of 0-19 indicates no anxiety, a score of 20-39 indicates mild, a score of 40-59 indicates moderate and a score of 60-79 indicates severe anxiety. It is stated that those who score 60 points and above need professional help.

Visual pain scale for pain assessment

时间窗: Before acupressure application, 20 minutes after acupressure application (20 minutes after application in the sham acupressure group, 20 min. after the initial measurement in the control group), immediately after the CABG procedure, 2 and 4 hours later

The scale is a 10 cm vertical or horizontal line on which patients mark their pain, with no pain written on one end and unbearable pain on the other. The distance between where the patient marks their pain and the no pain range is measured and recorded. The scale consists of five parts. Each of the sections is in the range of 2 points. '0' points - no pain, '1-2 points, very mild pain', '3-4 points, mild pain', '5-6 points, moderate pain', '7-8 points, severe pain' means '9-10 points, excruciating pain'.

次要结局

  • The heart rate measurement(Including a total of 5 measurements before the procedure, 20 minutes after the application, immediately after the procedure, 2 hours after the procedure, and 4 hours after the procedure.)
  • The blood pressure measurements(Including a total of 5 measurements before the procedure, 20 minutes after the application, immediately after the procedure, 2 hours after the procedure, and 4 hours after the procedure.)
  • Respiratory rate(Including a total of 5 measurements before the procedure, 20 minutes after the application, immediately after the procedure, 2 hours after the procedure, and 4 hours after the procedure.)
  • Oxygen saturation(Including a total of 5 measurements before the procedure, 20 minutes after the application, immediately after the procedure, 2 hours after the procedure, and 4 hours after the procedure.)

研究者

发起方
Bandırma Onyedi Eylül University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sarenur Ozen

Nurse, graduate student

Bandırma Onyedi Eylül University

研究点 (1)

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