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临床试验/NCT06534294
NCT06534294已完成不适用

Effect of Non-pharmacological Anti-anxiety Exercises on Perceived Stress and Cortisol Level Before Elective Per Cutaneous Transluminal Coronary Angioplasty

October 6 University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Cortisol Levels

研究概览

简要总结

Effect of non-pharmacological anti-anxiety exercises on Perceived Stress and cortisol level before elective percutaneous transluminal coronary angioplasty

详细描述

patients will be selected from national heart institute their age from 30 -50 years old. Patients will be assigned randomly into 4 groups 15 in each group, reflexology group, deep breathing group, combined group (reflexology and deep breathing) and control group. Before procedure two tools will used to collect data (demographic characteristics format the beginning once and Distress Thermometer scale before and 30 minutes after application in all groups ) in addition blood samples (5 mL) will take from all the patients on an empty stomach between 08:30 and 10:00 in the morning and 30 minutes after the application to determine the cortisol level in all groups

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
30 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Fully conscious patients, aged from 30 to 50 years.
  • will do percutaneous transluminal coronary angioplasty for the first time without any problem of communication.
  • accepting to give Blood samples available between 08:30 and 10:00 in the morning (to avoid differences in cortisol levels), and agreeing to participate in the study

排除标准

  • having myocardial infarction symptoms,
  • unconscious, having a surgery in the last 6 weeks,
  • previously diagnosed with a psychiatric disorder or still having a psychiatric disease, using anxiety medication (psychotropic), corticosteroid, using estrogen or amphetamine derivative drugs,
  • infection of the lower extremities, having varicose veins, having peripheral neuropathy and deep vein thrombosis or risk of development, high fever,

结局指标

主要结局

Cortisol Levels

时间窗: At subject enrollment "single session"

2 tubes of blood samples (5 mL) will take from the patients in all groups on an empty stomach between 08:30 and 10:00 in the morning and 30 minutes after the application to determine the cortisol level

Distress Thermometer

时间窗: At subject enrollment "single session"

It is a visual analog scale consisting of only 1 question that patients can apply on their own. On the scale, there is a thermometer with numbers from 0 to 10. A score of 0 indicates that the individual has no distress, and a score of 10 indicates distress at the highest limit.

次要结局

未报告次要终点

研究者

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

Amira Mohamed Afify

Associate professor

October 6 University

研究点 (2)

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