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临床试验/NCT06602128
NCT06602128已完成不适用

The Effect of Breathing Exercise on Anxiety, Pain and Vital Signs in Patients Undergoing Coronary Angiography: A Randomised Controlled Study

Kahramanmaraş İstiklal University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年9月18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
90
试验地点
1
主要终点
Vital Signs Recording Form-Blood pressure values

研究概览

简要总结

This randomised controlled trial will be conducted to evaluate the effect of breathing exercise on anxiety, pain and vital signs in patients undergoing coronary angiography before angiography.

Hypotheses of the study; H11: The anxiety level of the patients who underwent breathing exercise is lower than the patients in the control group.

H12: The pain level of the patients who underwent breathing exercise is lower than the control group H13: The vital signs of the patients who underwent breathing exercises are within normal limits compared to the control group.

In the study, there will be an intervention group in which breathing exercise will be applied and a control group in which no intervention will be applied.

Data will be collected with the pre-test data collection form half an hour before the angiography procedure in patients in the intervention and control groups. Patients in the intervention group will be given breathing exercises, while patients in the control group will not be subjected to any intervention. After the angioplasty procedure, data will be collected from the intervention and control groups with post-test data collection forms.

详细描述

In determining the groups; simple randomisation method will be used in order to form the sample in a way to ensure equal number and random distribution of the two groups. Randomisation will be done by using the website (https://www.randomizer.org). In line with the randomisation list; patients who meet the inclusion criteria will be included in the intervention and control groups. Inclusion in the intervention and control groups will be made by the researchers in line with the randomisation list. In order for the responsible researcher to apply breathing exercises; he/she has a breathing techniques coaching certificate. In the research; triple breathing technique (full yogic breathing) and square breathing technique will be used. Patients will be informed about the research and their written and verbal consent will be obtained. Data will be collected with the pre-test data collection form half an hour before the angiography procedure in patients in the intervention and control groups. Patients in the intervention group will be given breathing exercises, while patients in the control group will not be subjected to any intervention. The breathing exercise will be performed as a single session and will last approximately 15-20 minutes. After the angioplasty procedure, data will be collected from the intervention and control groups with post-test data collection forms.

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 (Outcomes Assessor)

盲法说明

The post-test measurements will be collected by a nurse working in the angiography ward who is not connected with the study.

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

  • Patients undergoing coronary angiography for the first time
  • Over 18 years of age
  • No respiratory distress
  • No problems with communication
  • Volunteering to be included in the study.

排除标准

  • Taking any medication to suppress anxiety symptoms
  • Patients undergoing emergency coronary angiography and/or patients complaining of chest pain
  • Patients on antihypertensive treatment before the procedure due to hypertension
  • Patients who underwent emergency intervention during coronary angiography, surgical procedure and intensive care unit for follow-up were excluded from the study.

结局指标

主要结局

Vital Signs Recording Form-Blood pressure values

时间窗: Within 15 minutes after the angiography procedure is completed and the patient is taken to bed

It is a form created by the researcher in which the blood pressure values of the patients are recorded.

Vital Signs Recording Form- Saturation

时间窗: Within 15 minutes after the angiography procedure is completed and the patient is taken to bed

It is a form created by the researcher in which the saturation values of the patients are recorded.

Vital Signs Recording Form- Pulse values

时间窗: Within 15 minutes after the angiography procedure is completed and the patient is taken to bed

It is a form created by the researcher in which the pulse rates of the patients are recorded.

Visual Analogy Scale (VAS)

时间窗: Within 15 minutes after the angiography procedure is completed and the patient is taken to bed

It is a 10 cm ruler that reflects the minimum and maximum state of pain by using it horizontally or vertically. '0' indicates painlessness and "10" indicates the most severe pain. The patient marks the intensity of pain felt on this ruler.

State-Trait Anxiety Inventory (STAI-I)

时间窗: Within 15 minutes after the angiography procedure is completed and the patient is taken to bed

The scale developed by Spielberg et al. (1964) was adapted into Turkish by Öner and Le Compte (1974-1977). The reliability of the scale is determined between 0.83 and 0.92 and it requires the person to understand his/her situation at certain times and conditions and to mark one of the preferences '1 (Not at all), 2 (A little), 3 (Very), 4 (Completely)' according to its severity. The total score obtained from the scale varies between 20-80 and 20-39 indicates mild anxiety level, 40-59 indicates moderate anxiety level, 60-79 indicates high anxiety level and 80 points indicates panic anxiety level.

次要结局

未报告次要终点

研究者

发起方
Kahramanmaraş İstiklal University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yasemin Sazak

Assistant Professor

Kahramanmaraş İstiklal University

研究点 (1)

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