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临床试验/NCT04998526
NCT04998526Unknown不适用

The Effect of Local Cold Application on Hypertension

Ataturk University1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2021年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
72
试验地点
1
主要终点
Blood pressure

研究概览

简要总结

This study will be conducted to evaluate the effect of local cold application to the nape of the neck on systolic blood pressure, diastolic blood pressure, heart rate, heart rate pressure and headache.

详细描述

Aim: This study will be conducted to evaluate the effect of local cold application to the nape of the neck on systolic blood pressure, diastolic blood pressure, heart rate, heart rate pressure and headache.

Material and method: This study, which is planned as a randomized controlled and experimental study, will be conducted with type 2 (systolic blood pressure between 160 and 179 mmHg, diastolic blood pressure between 100 and 109 mmHg) essential hypertension patients who refer to Van Yüzüncü Yıl University Dursun Odabaş Medical Centre Emergency Service. The patients will be distributed as 24 in experimental group, 24 in placebo group and 24 in control group based on block randomization (gender and age) method and a total of 72 patients will be included. Patient information form, blood pressure and heart rate monitoring form and VAS pain scale will be used to collect study data. Patients in all groups will be measured in 90 minutes for a total of 8 times, as pre-test (pre-application) and post-test (minutes 3, 10, 15, 20, 30, 60 and 90). After routine medication therapy is given to all three groups, the cold gel pack which has been kept at least for four hours in the freezer will be applied to the nape of the patients in the experimental group, while gel pack at room temperature will be applied to the placebo group and no application will be made to the control group. Variance analysis, Friedman analysis, t test, Wilcoxon test and Kruskal Wallis analysis will be used in data assessment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

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

  • •25 mg sublingual ACE inhibitor given as a treatment protocol,
  • •No wound on the nape,
  • •Does not develop cold intolerance,
  • •Not taking any hypertension medication and pain medication in the last 6 hours,
  • •Without heart diseases, peripheral arterial circulation disorders, sensory disorders and edema,
  • •Not pregnant,
  • •Agreeing to participate in the study,
  • •Essential hypertension patients with systolic blood pressure 160 - 179 mmHg, diastolic blood pressure 100 - 109 mmHg.

排除标准

  • •Developing cold intolerance,
  • •Changes in the treatment regimen,
  • •Panic attack, allergic reaction and any similar situation develops,
  • •Those who want to withdraw from the research

研究组 & 干预措施

Experimental group

Experimental

After routine drug treatment is given to hypertension patients, the cold gel pack will be applied to the nape for 3 minutes.

干预措施: Experimental group (Other)

Placebo group

Placebo Comparator

After routine drug therapy is given to hypertension patients, the gel pack kept at room temperature will be applied to the nape for 3 minutes.

干预措施: Placebo group (Other)

Control group

No Intervention

Routine drug treatment will be given to hypertension patients and no application will be made.

结局指标

主要结局

Blood pressure

时间窗: 90 minute

Lowering blood pressure

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

YAVUZ ÜREN

PhD Student

Ataturk University

研究点 (1)

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