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临床试验/NCT06643182
NCT06643182尚未招募不适用

Effect of Back Support on Vital Signs and Comfort After Transfemoral Angiography

Inonu University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
试验地点
1
主要终点
Effect of back support use on pulse

研究概览

简要总结

In the routine treatment procedure after coronary angiography (CAG), the patients remain in the supine position for a long time, which leads to decreased venous return and back pain. In addition, lying in the same position for 2 hours or more in the back area causes an increase in pressure. Increased pressure disrupts cell and tissue blood supply. The resulting pain may increase sympathetic stimulation. Therefore, sympathetic stimulation increases heart rate, blood pressure, myocardial oxygen consumption and cardiac workload. After the transfemoral coronary angiography (CAG) procedure, which is frequently applied to adults for both diagnosis and treatment, the back support to be applied to ensure that the vital signs (pulse, blood pressure, respiratory rate and blood oxygen saturation) of the patients remain stable and to increase their comfort level can prevent the deviation of the vital signs of the patients from normal and contribute to the treatment process with patient satisfaction.

详细描述

In the routine treatment procedure after coronary angiography (CAG), the patients remain in the supine position for a long time, which leads to decreased venous return and back pain. In addition, lying in the same position for 2 hours or more in the back area causes an increase in pressure. Increased pressure disrupts cell and tissue blood supply. The resulting pain may increase sympathetic stimulation. Therefore, sympathetic stimulation increases heart rate, blood pressure, myocardial oxygen consumption and cardiac workload. After the transfemoral coronary angiography (CAG) procedure, which is frequently applied to adults for both diagnosis and treatment, the back support to be applied to ensure that the vital signs (pulse, blood pressure, respiratory rate and blood oxygen saturation) of the patients remain stable and to increase their comfort level can prevent the deviation of the vital signs of the patients from normal and contribute to the treatment process with patient satisfaction.

This study will be conducted to evaluate the effect of back support on patients undergoing transfemoral angiography on the patients' vital signs, which are defined as pulse, blood pressure, respiratory rate and blood oxygen saturation (SPO2), as well as comfort levels indicating satisfaction levels.

The study is planned to be completed between September 1, 2024 and April 1, 2025. The universe of the study, which was conducted as a randomized controlled trial model, consisted of patients who underwent angiography in the cardiovascular surgery intensive care units of Tunceli State Hospital. Randomization of the participants was planned to be assigned to the experimental and control groups via random.org (Back support group=40, Control group=40). "Patient Information Form", "Visual Analog Scale (VAS)" and "Immobilization Comfort Scale (IMC)" will be used in data collection. General linear model and mixed ANOVA analysis will be performed according to the characteristics of the data.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients over the age of 18 who underwent femoral coronary angiography,
  • Patients who did not have verbal communication problems,
  • Patients who consented to participate in the study were determined as patients.

排除标准

  • Patients who underwent radial angiography,
  • Have chronic low back pain,
  • Have had previous back surgery/herniated disc,
  • Have coagulation problems (PLT<50000 mm3),
  • Did not consent to participate in the study,
  • Have communication problems.

结局指标

主要结局

Effect of back support use on pulse

时间窗: 6 hour (Data collection time for each patient)

Patients will be monitored for 6 hours in a supported supine position and Pulse will be recorded at 3-hour intervals.

Effect of back support use on blood pressure

时间窗: 6 hour (Data collection time for each patient)

Patients will be monitored for 6 hours in a supported supine position and blood pressure will be recorded at 3-hour intervals.m

Effect of back support use on respiratory rate

时间窗: 6 hour (Data collection time for each patient)

Patients will be monitored for 6 hours in a supported supine position and respiratory rate will be recorded at 3-hour intervals.m

Effect of back support use on partial oxygen saturation

时间窗: 6 hour (Data collection time for each patient)

Patients will be monitored for 6 hours in a supported supine position and partial oxygen saturation will be recorded at 3-hour intervals.m

Effect of back support use on comfort

时间窗: 6 hour

The immobilization comfort scale consists of 20 items and 6 statements. The total score is between 20 and 120. Scoring was done before and after back support.

次要结局

  • Effect of back support use on pain(6 hour)

研究者

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

Zeliha CENGİZ

associate proffesor

Inonu University

研究点 (1)

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