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临床试验/NCT04572672
NCT04572672已完成不适用

Effect of Pursed-Lip Breathing Combined With Number Counting on Blood Pressure and Heart Rate in Hypertensive Urgency Patients: A Randomized Controlled Trial

Khon Kaen University2 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2019年9月1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
112
试验地点
2
主要终点
Change of systolic blood pressure

研究概览

简要总结

Hypertensive urgency (HT urgency) is an alarm sign of uncontrolled hypertension. It can be aggravated by nonadherent to medication and psychosocial stress. Mindfulness is beneficial for reducing stress, while deep and slow breathing is effective for blood pressure (BP) lowering. The objective of the study was to assess the effect of pursed-lip breathing with number counting (PLB with NC) that promotes mindfulness and a deep/slow breathing pattern on BP and heart rate (HR) in the HT urgency patients.

详细描述

This was a single-blinded randomized controlled trial. Patients aged between 18-80 years old, diagnosed with HT urgency, who presented at the emergency room of Srinagarind hospital (a 1000-bed, tertiary-care level university hospital), Khon Kaen University between September 1st, 2019 to June 30th, 2020, were enrolled. Those with cardiac arrhythmias, acute HF, acute coronary syndromes, acute stroke, acute respiratory failure, alteration of consciousness, and pregnant women were excluded. This study was approved by the Khon Kaen University Ethical Review Board in Human Research (HE611586). All patients gave their written informed consent before the enrollment.HT urgency was defined as SBP >180 mmHg and/or DBP >110 mmHg without any signs or symptoms of target organ damages.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-80 years old patients who diagnosed with HT urgency, who presented at the emergency room

排除标准

  • Patients with cardiac arrhythmias,
  • Acute heart failure
  • Acute coronary syndromes
  • Acute stroke
  • Acute respiratory failure
  • Alteration of consciousness
  • Pregnant women

结局指标

主要结局

Change of systolic blood pressure

时间窗: pre-intervention and 3 hours after the intervention

The change of systolic blood pressure level was assessed.

Change of diastolic blood pressure

时间窗: pre-intervention and 3 hours after the intervention

The change of diastolic blood pressure level was assessed.

Change of heart rate

时间窗: pre-intervention and 3 hours after the intervention

The change of heart rate was assessed.

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

Praew Kotruchin

Assistant professor

Khon Kaen University

研究点 (2)

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