The Effect of Mindfulness-Based Breathing Exercises on Symptom Control

March 11, 2026 updated by: Gui Dural, Firat University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Elâzığ, Turkey (Türkiye)
        • Recruiting
        • Gül DURAL
        • Contact:
        • Principal Investigator:
          • Gül DURAL, pHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients with communication problems • Patients with psychiatric problems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
Breast cancer patients receiving chemotherapy who will receive mindfulness-based breathing exercises in addition to routine care.
Behavioral: Mindfulness-Based Breathing Exercise
Mindfulness-based breathing exercises focusing attention on breathing to promote awareness and support symptom management in breast cancer patients receiving chemotherapy.
No Intervention: Control Group
Breast cancer patients receiving chemotherapy who will receive routine care only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom Severity
Time Frame: 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).
Baseline and after the intervention period (e.g., 8 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Salivary Cortisol Level
Time Frame: Baseline and after the intervention period (e.g., 8 weeks)
Assessment of stress level by measuring salivary cortisol levels in breast cancer patients undergoing chemotherapy.
Baseline and after the intervention period (e.g., 8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Firat University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2026

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

August 15, 2026

Study Registration Dates

First Submitted

March 11, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/15-52

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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