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临床试验/NCT07474337
NCT07474337招募中不适用

The Effect of Mindfulness-Based Breathing Exercises on Symptom Control and Salivary Cortisol Levels in Breast Cancer Patients Undergoing Chemotherapy

Firat University1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2026年3月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
72
试验地点
1
主要终点
Symptom Severity

研究概览

简要总结

This randomized controlled experimental study aims to evaluate the effect of mindfulness-based breathing exercises on symptom management and salivary cortisol levels in breast cancer patients receiving chemotherapy. The study population will consist of breast cancer patients undergoing chemotherapy treatment in the Oncology Department of Fırat University Hospital. A total of 72 patients who meet the inclusion criteria and volunteer to participate will be included in the study, with 36 patients in the experimental group and 36 in the control group. Data will be collected using the Personal Information Form and the Edmonton Symptom Assessment Scale. The findings of this study are expected to provide evidence regarding the effectiveness of mindfulness-based breathing exercises in improving symptom management and reducing stress levels in breast cancer patients receiving chemotherapy.

详细描述

Cancer is a disease caused by the combined effect of various genetic and environmental factors that lead to the uncontrolled division and proliferation of cells. From the diagnosis stage, cancer affects the quality of life due to various symptoms associated with the disease and its treatment. This causes cancer patients to experience physiological and psychological stress. Today, many patients use non-pharmacological methods to manage these symptoms. As a result of the increasing interest of individuals in society in non-pharmacological methods, it has become a necessity for healthcare professionals, whose aim is to meet the health needs of the community, and nurses as members of the healthcare team, to play a role in these methods. One of the practices that nurses can offer patients for symptom management is mindfulness-based breathing exercises. In this body-mind-based practice, all attention is brought to the breath, enabling individuals to create awareness about their negative thoughts and feelings. This research is planned as a randomized controlled experimental study to evaluate the effect of mindfulness-based breathing exercises applied to breast cancer patients receiving chemotherapy on symptom management and salivary cortisol levels. The population of the study will consist of breast cancer patients receiving chemotherapy treatment in the Oncology Department of Fırat University Hospital. The sample will consist of patients who meet the research criteria and volunteer to participate in the study. A power analysis was conducted to determine the sample size, with a 0.05 error margin, a 0.95 confidence interval, an effect size of 0.5, and a population representation of 0.80, resulting in 72 patients for both the experimental and control groups. The total sample size for the study will be 36 patients in each group. The Personal Information Form and the Edmonton Symptom Assessment Scale will be used as data collection tools. The SPPS (Statistical Programme for Social Sciences) software package will be used to analyze the data obtained from the research. This study aims to determine the effect of mindfulness-based breathing exercises on symptom management and salivary cortisol levels in breast cancer patients undergoing chemotherapy.

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 (Participant)

入排标准

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

入选标准

  • Being over 18 years of age
  • Knowing their diagnosis
  • Receiving chemotherapy for the first time due to a breast cancer diagnosis
  • Having breast cancer stages I, II, or III (stage 4 patients were not included in the study as metastatic spread would increase symptoms and make communication with the patient difficult),
  • Not receiving treatment for another cancer,
  • Not having a physical disability that would prevent telephone interviews (hearing, speech),
  • Not having any psychiatric disorder that would impair comprehension and understanding,
  • Patients who have verbally and in writing consented to participate in the study will be included in the research.

排除标准

  • Patients with communication problems • Patients with psychiatric problems

研究组 & 干预措施

Control Group

No Intervention

Breast cancer patients receiving chemotherapy who will receive routine care only.

Experimental Group

Experimental

Breast cancer patients receiving chemotherapy who will receive mindfulness-based breathing exercises in addition to routine care.

干预措施: Mindfulness-Based Breathing Exercise (Behavioral)

结局指标

主要结局

Symptom Severity

时间窗: Baseline and after the intervention period (e.g., 8 weeks)

Evaluation of symptom severity in breast cancer patients receiving chemotherapy using the Edmonton Symptom Assessment Scale (ESAS).

次要结局

  • Salivary Cortisol Level(Baseline and after the intervention period (e.g., 8 weeks))

研究者

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

Gui Dural

Assistant professor

Firat University

研究点 (1)

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