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临床试验/NCT05930587
NCT05930587尚未招募不适用

Effect of Lower Extremities Cold Immersion Applied to Patients With Varicose Veins on Quality of Life, Anxiety and Symptoms

Gazi University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年9月25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
60
试验地点
2
主要终点
The Patient Questionnaire

研究概览

简要总结

In the literature, it is stated that cold water immersion to lower extremities is effective on the symptoms of the disease. Studies have shown that cold water immersion, which is one of the cold application methods, has effects on increasing joint mobility, reducing pain, reducing stress, anxiety, depression, and increasing quality of life etc.

For this reason, the study is planned as a randomized controlled interventional study to determine the effect of cold water immersion directly to the lower extremity in the preoperative period of patients with varicose veins on quality of life, anxiety and symptoms experienced.

详细描述

The experimental group will be informed about the lower extremity cold immersion bath during the outpatient clinic controls and will be given a liquid meter digital thermometer that will allow them to check the cold water temperature at home. Patients will then be asked to do the lower extremity cold water immersion bath every day in their own home, for a total of four weeks, lasting 20 minutes in the evening before going to sleep.

It is recommended that the cold water immersion for 20 minutes and the temperature of the water should be 15 0C for it to be effective on the symptoms.

At the end of four weeks, patients will be informed that they should come to the outpatient clinic again. When the patients come to the outpatient clinic, information about the application will be repeated and data collection forms will be applied by face-to-face interview method.

To the patients in the control group; during the research process, routine outpatient controls will be made and no attempt will be made during the research.

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 (Investigator, Outcomes Assessor)

盲法说明

The patients in the experimental and control groups in the study will be assigned to the groups by a statistician using a computer program, and the list of patients in the experimental and control groups will be submitted to the head nurse of the cardiovascular surgery clinic.Researchers will not be informed about which group the patients are in.

In the research, the application of cold immersion to the patients in the experimental group will be explained by the nurse in charge, and data collection forms will be applied to both the experimental and control groups by the head nurse.

As the patients will do the application directly themselves, blinding will not be possible.

In addition, codes in the form of x and y will be given to the experimental and control groups and support will be received from another statistical expert.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Those between the ages of 18-65
  • Those who have been diagnosed with lower extremity varicose disease for at least 1 year
  • Those who have not had previous surgery due to varicose veins
  • No visual, hearing and sensory impairment/neurosensor disorder problem
  • No mental status disorder
  • With intact skin integrity and no open wounds
  • No circulatory disorder

排除标准

  • The patient has a known cold allergy or hypersensitivity to cold
  • Patient having surgery during the study
  • The patient's desire to withdraw from the study

结局指标

主要结局

The Patient Questionnaire

时间窗: four weeks

This form was created by the researcher based on the literature. This form consists of questions which sociodemographic characteristics (age, gender, body mass index, marital status, living people, educational status, employment status, economic status), characteristics of health status (presence of chronic diseases, drugs used regularly, smoking and alcohol use), characteristics of varicose disease (how many years have varicose veins, which leg has varicose veins, family history of varicose veins, previous surgery for varicose veins and use of varicose stockings), and physical symptoms experienced due to varicose veins (expected to score according to 0-10 evaluation scale). according to the characteristics (how many years have varicose disease, which leg has varicose veins, family history of varicose veins, previous surgery for varicose veins and using varicose stockings).

次要结局

  • VEINES-QOL/Sym(four weeks)

研究者

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

Nevra KALKAN

Res. Asst. PhD NEVRA KALKAN, Faculty of Nursing, Department of Surgical Nursing

Gazi University

研究点 (2)

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