跳至主要内容
临床试验/NCT07752706
NCT07752706进行中(未招募)不适用

The Effect of Breathing Exercises on Dyspnea and Anxiety in Patients Presenting to the Emergency Department Due to Heart Failure

Istanbul University - Cerrahpasa1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2025年3月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
112
试验地点
1
主要终点
Change in psychological distress measured by the Distress Thermometer

研究概览

简要总结

Heart failure is a leading cause of emergency department admissions, with dyspnea and psychological distress being among the most common presenting symptoms. This randomized controlled trial aims to evaluate the effect of nurse-guided diaphragmatic breathing and pursed-lip breathing exercises on dyspnea and psychological distress in patients presenting to the emergency department with heart failure. A total of 112 eligible participants will be randomly assigned in a 1:1 ratio to either an intervention group receiving breathing exercises in addition to standard care or a control group receiving standard care alone. Dyspnea severity will be assessed using the Modified Borg Dyspnea Scale, and psychological distress will be assessed using the Distress Thermometer at predefined time points. The findings are expected to provide evidence for the effectiveness of a simple, low-cost, nurse-led non-pharmacological intervention in improving symptom management in patients with heart failure.

详细描述

Heart failure is a major public health problem associated with frequent emergency department admissions due to symptoms such as dyspnea and anxiety. Dyspnea is one of the most distressing symptoms experienced by patients with heart failure and is often accompanied by increased anxiety, which may further worsen respiratory distress. Although pharmacological treatment remains the cornerstone of acute management, non-pharmacological interventions, including breathing exercises, may provide additional symptom relief.

The aim of this randomized controlled trial is to evaluate the effect of diaphragmatic breathing and pursed-lip breathing exercises on dyspnea and anxiety in patients presenting to the emergency department with heart failure.

A total of 112 eligible patients will be randomly assigned to either an intervention group or a control group. Participants in the intervention group will receive standard emergency department care in addition to nurse-guided diaphragmatic breathing and pursed-lip breathing exercises. The control group will receive standard emergency department care alone.

Clinical parameters, including pulse rate, blood pressure, respiratory rate, oxygen saturation, and distress level, will be assessed according to the study protocol. Dyspnea severity will be evaluated using the Modified Borg Dyspnea Scale, and anxiety-related distress will be assessed using the Distress Thermometer. Outcome measurements will be obtained at baseline and at predefined time points following the intervention.

The primary objective is to determine whether breathing exercises reduce dyspnea severity and anxiety compared with standard care. The findings of this study are expected to provide evidence regarding the effectiveness of a simple, low-cost, and nurse-led non-pharmacological intervention that may improve symptom management in patients with heart failure treated in emergency departments.

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
Single (Outcomes Assessor)

盲法说明

Due to the nature of the breathing exercise intervention, participants and the investigator delivering the intervention could not be blinded. To minimize bias, data were coded as Group A and Group B, and statistical analyses were performed by an independent statistician who was blinded to group allocation.

入排标准

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

入选标准

  • Applicants must be 18 years of age or older. Volunteer to participate in the study. Present to the emergency department of the hospital where the study is planned to be conducted.
  • Having been diagnosed with NYHA stage III-IV heart failure by a physician. Being able to understand and speak Turkish.

排除标准

  • Being under 18 years of age Not being a volunteer to participate in the study Using narcotic analgesics to a degree that affects understanding questions and communication, Having a diagnosis of serious mental illness Not having been diagnosed with NYHA stage III-IV heart failure by a physician

研究组 & 干预措施

Control

No Intervention

No Intervention

Experimental

Experimental

Behavioral: Diaphragmatic and Pursed-Lip Breathing Exercises

干预措施: Diaphragmatic and Pursed-Lip Breathing Exercises (Other)

结局指标

主要结局

Change in psychological distress measured by the Distress Thermometer

时间窗: Baseline (before intervention), and at 5, 10, 15, 30, 45, and 60 minutes after initiation of the intervention.

Psychological distress will be assessed using the Distress Thermometer

Change in dyspnea severity measured by the Modified Borg Dyspnea Scale

时间窗: Baseline (before intervention), and at 5, 10, 15, 30, 45, and 60 minutes after initiation of the intervention.

Dyspnea severity will be assessed using the Modified Borg Dyspnea Scale

次要结局

未报告次要终点

研究者

发起方
Istanbul University - Cerrahpasa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayşe Ağca

phd student

Istanbul University - Cerrahpasa

研究点 (1)

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