The Effect of Mindfulness-Based Breathing Exercises on Dy... | NCT07520799

Status Module

Description Module

Brief Summary

This research is designed to determine the effect of mindfulness-based breathing exercises on dyspnea, symptom control, and quality of life in lung cancer patients undergoing chemotherapy. Lung cancer is a disease with a high mortality rate and a heavy symptom burden, and symptoms such as dyspnea, fatigue, pain, anxiety, and sleep problems are frequently observed during chemotherapy. Dyspnea, in particular, is one of the main symptoms that has both physical and emotional dimensions and significantly negatively affects patients' daily living activities, adherence to treatment, and quality of life. Therefore, integrating non-pharmacological and complementary nursing interventions into the care process in addition to pharmacological approaches is important. Mindfulness-based breathing exercises are a structured application that aims to regulate the respiratory rhythm, increase relaxation, and reduce symptom perception by enabling the individual to focus on their breath and bodily sensations without judgment. The research will be conducted using a pre-test-post-test control group experimental design. The study will be carried out with lung cancer patients receiving chemotherapy at Gazi Yaşargil Training and Research Hospital between April 2026 and September 2026. The study sample will consist of a total of 60 patients (30 experimental, 30 control) who meet the inclusion criteria and voluntarily agree to participate. Randomization will be used to determine the groups. Patients in the intervention group will receive a mindfulness-based breathing exercise program for eight weeks. The first four weeks will consist of 20-30 minute face-to-face individual training sessions once a week, followed by four weeks of 15-20 minute exercises at home twice a week. The control group will receive no intervention other than routine care. Data will be collected before and eight weeks after the intervention using a Personal Information Form, the Edmonton Symptom Assessment Scale, the EORTC QLQ-C30 Quality of Life Scale, and the Dyspnea-12 TR Scale. Frequency, percentage, mean, and standard deviation will be calculated for data analysis; chi-square test, independent samples t-test, and dependent samples t-test will be used for intergroup comparisons. This study is expected to provide evidence-based contributions to nursing care by demonstrating the effectiveness of mindfulness-based breathing exercises in reducing dyspnea and symptom burden and improving quality of life in lung cancer patients undergoing chemotherapy.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mindfulness-Based Breathing Exercises	Experimental	The group where the application was made	Behavioral: Mindfulness-Based Breathing Exercises
Control group	No Intervention	The group where the application was not made

Name	Type	Description	Arm Group Labels	Other Names
Mindfulness-Based Breathing Exercises	Behavioral	Mindfulness-Based Breathing Exercises	Mindfulness-Based Breathing Exercises

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Edmonton Symptom Assessment Scale:	The Edmonton Symptom Assessment Scale was developed by Bruera et al. to assess .nine common symptoms in cancer patients (Çalışkan, Gürhan, and Tekgündüz, 2017). The scale includes nine symptoms: pain, fatigue, nausea, sadness, anxiety, insomnia, loss of appetite, malaise, and shortness of breath. In the Turkish validity and reliability study conducted by Sadırlı (2008), skin and nail changes, mouth sores, and numbness in the hands were added to the original scale. Each symptom is evaluated on a numerical scale from 0 to 10. A score of 0 indicates that the symptom is not experienced at all; a score of 10 indicates that the symptom is experienced at its most severe level. The basic principle of the scale is that the patient makes their own assessment. Patients are asked to indicate the number that they think best reflects the severity of the symptom they are experiencing."Higher scores on the Edmonton Symptom Assessment Scale indicate greater symptom severity."	8 week
EORTC QLQ-C 30 Quality of Life Scale	The EORTC QLQ-C30 Quality of Life Scale was developed in 1987 by the European Organization for Cancer Treatment and Research (EORTC) to assess the quality of life of cancer patients and was later revised by Aaronson et al. (Jameson et al., 2018). The adaptation of the scale to the Turkish population and the validity-reliability study were carried out by Güzelant et al., and the Cronbach alpha coefficient was found to be 0.70.	8 week
DYSPNEA-12 TR SCALE	The Dyspnea-12 scale was developed by Yorke et al. to assess both the physical and emotional dimensions of dyspnea symptoms and was published in 2011 (Yorke et al., 2011). Consisting of 12 items, the scale has a four-point Likert-type response system, with each item scored from 0 to "none", 1 to "mild", 2 to "moderate", and 3 to "severe". The first seven items of the scale are aimed at evaluating the physical symptoms related to dyspnea. Through these items, physical symptoms such as difficulty breathing, insufficient air reaching the lungs, and increased effort required during breathing are investigated. The remaining five items of the scale evaluate the effects of shortness of breath on the individual's emotional state; focusing on emotional responses such as stress, irritability, depressive mood, general distress, and restlessness.Higher scores on the Dyspnea-12 indicate greater severity of breathlessness.

Eligibility Module

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases