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
Phase: NA
Conditions: Palliative Patients, Terminal Malignant Tumors, Breathing Techniques
Sponsor: Atlas University

  
Study Protocol and Statistical Analysis Plan on Palliative Study 
 
Official Study Title: 
The Effect of Structured Breathing Exercises on Pain, Dyspnea, and Functionality in Terminal 
Stage Cancer Patients Receiving Palliative Care 
NCT Number: 
Pending 
Document Type: 
[Study Protocol and Statiscal Analysis]  
Principal Investigator: 
Fatma Nur Yildiz Yildirim, PT, MSc 
Department of Physiotherapy and Rehabilitation 
Istanbul Atlas University, Turkey 
  https://orcid.org/0009-0009-7607-7446 
 
Date of the Document: 
August 07, 2025 
Study Site: 
  Eyupsultan State Hospital, Istanbul, Turkey 
 
Study Design: 
- Interventional, randomized controlled trial (RCT) 
- Two-arm parallel design (Intervention vs. Control) 
- Single-blinded (evaluator) 
 
Study Population: 
- Total of 39 terminal-stage cancer patients receiving palliative care 
- Intervention group (n = 22), Control group (n = 17) 
 
 

  
Study Protocol and Statistical Analysis Plan on Palliative Study 
 
Inclusion Criteria: 
- Age >18 years 
- Terminal stage cancer diagnosis 
- Receiving inpatient palliative care 
- Able to provide consent or have a legal representative 
 
 
Exclusion Criteria: 
- Cognitive impairment preventing exercise compliance 
- Severe respiratory instability 
 
 
Intervention Description: 
-The intervention group received structured breathing exercises consisting of pursed-lip breathing, diaphragmatic breathing, respiratory 
control, relaxation breathing exercises, and slow, deep breathing, once a day for 5 days, for an average of 15 minutes. 
Exercises administered by a physiotherapist. Conducted once daily for 5 consecutive days 
 
Control Group: 
- Receives standard palliative care and an informational booklet that describing breathing exercises. 
 
Primary Outcomes: 
1. Pain level (measured by Visual Analog Scale - VAS) 
2. Dyspnea (measured by Cancer Dyspnea Scale - CDS) 
3. Functionality (measured by ESAS-r functional subscale) 
 
Secondary Outcomes: 
- SpO2, pulse rate, hemoglobin, leukocyte, platelet, CRP levels 

  
Study Protocol and Statistical Analysis Plan on Palliative Study 
 
 
 
Data Collection Time Points: 
- Baseline (Day 0) 
- Post-intervention (Day 5) 
 
 
Data Analysis: 
- Data analyzed using SPSS Statistics v27 
- Kolmogorov-Smirnov test for normality 
- t-tests, Wilcoxon signed-rank test, and Mann-Whitney U test as appropriate 
- Effect size reported using Cohen's d 
 
 
Ethical Considerations: 
- Study approved by local ethics committee (IRB) 
 -Informed consent was obtained from all participants or their legal representatives. 
-University Ethics Committee was approved this study (# 44948; July 4, 2024). 
 
Study Timeline: 
- Start Date: October 2024 
- Completion Date: May 2025