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临床试验/NCT07164352
NCT07164352已完成不适用

Effect of Breathing Exercises on Pain, Dyspnea, and Functionality in Terminal-Stage Cancer Patients Receiving Palliative Care - Master's Thesis, İstanbul Atlas University, Graduate School, Dept. of Physical Medicine and Rehabilitation

Atlas University2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2024年8月4日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
58
试验地点
2
主要终点
dyspnea

研究概览

简要总结

This study aims to evaluate the effects of supervised breathing exercises on pain, dyspnea, and functionality in terminal-stage cancer patients receiving palliative care. Participants in the intervention group receive diaphragmatic and pursed-lip breathing exercises under the guidance of a physiotherapist, while the control group receives only an educational brochure. The study compares pre- and post-intervention outcomes between both groups.

详细描述

This randomized controlled trial aims to investigate the effects of diaphragmatic and pursed-lip breathing exercises on pain, dyspnea, and functional status in terminal-stage cancer patients receiving palliative care. Participants are divided into two groups: the intervention group receives supervised breathing exercises by a physiotherapist, while the control group is given an informational brochure without any physical guidance.

The primary objective is to determine whether supervised breathing exercises provide significant improvements in symptom control and functionality compared to usual care. Assessments are made before and after the intervention using validated tools including the Edmonton Symptom Assessment System (ESAS-r), the Cancer Dyspnea Scale (CDS), and the Visual Analog Scale (VAS) for pain.

The study aims to contribute to the clinical evidence supporting non-pharmacological interventions in palliative care and to offer practical approaches for improving quality of life in terminally ill cancer patients.

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

入选标准

  • Patients receiving palliative care, who are part of this treatment process and considered eligible for the study.
  • Patients diagnosed with Stage 4 cancer, included in the study due to their advanced cancer stage.
  • Patients with oxygen saturation levels below 95% in room air, who are deemed appropriate for monitoring respiratory function due to this condition.
  • Participants must be able to effectively communicate during the study period.
  • Individuals who agree to participate in the study must provide written or verbal consent, which is a mandatory criterion for ethical compliance.

排除标准

  • Patients who are unconscious and unable to participate in the study. Individuals under the age of
  • Patients dependent on a ventilator.
  • Patients with serious health issues, such as uncontrolled hypertension and dyspnea.
  • Patients with other significant health problems that prevent participation in the research program.
  • Patients with medical conditions requiring drainage treatment.

结局指标

主要结局

dyspnea

时间窗: From enrollment to the end of treatment at 1 weeks

Dyspnea severity will be assessed using the Edmonton Symptom Assessment System - revised (ESAS-r) dyspnea item. This is a numeric rating scale ranging from 0 to 10, where 0 indicates no shortness of breath and 10 indicates the worst possible shortness of breath. The outcome will evaluate changes in dyspnea severity following a structured breathing exercise intervention.

Functionality

时间窗: From enrollment to the end of treatment at 1 weeks

Functionality will be measured using the Edmonton Symptom Assessment System - revised (ESAS-r) physical well-being domain. The ESAS-r is a validated self-report instrument in which patients rate symptom severity on a scale from 0 to 10, with 0 indicating no impairment and 10 indicating the worst possible level of functional impairment. This outcome assesses changes in participants' ability to perform daily activities such as walking, dressing, and self-care.

次要结局

未报告次要终点

研究者

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

Fatma Nur Yildiz

Physiotherapist

Atlas University

研究点 (2)

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