- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06318455
The Effect of Breathing Exercise on Sleep and Stress Levels in Women With Breast Cancer Receiving Chemotherapy Treatment
March 4, 2025 updated by: Gürcan Solmaz, University of Yalova
İstanbul University-Cerrahpaşa
Women receiving chemotherapy have poor sleep quality and high stress levels.
With a method such as breathing exercise, which can be applied at any time without side effects, positive improvements in women's sleep and stress levels can be recorded.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Women receiving chemotherapy have poor sleep quality and high stress levels.
With a method such as breathing exercise, which can be applied at any time without side effects, positive improvements in women's sleep and stress levels can be recorded.
Study Type
Interventional
Enrollment (Actual)
65
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
-
-
-
Istanbul, Turkey
- University of İstanbul-cerrahpaşa (IUC)
-
-
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:
- women receiving chemotherapy women with poor sleep quality 18 years of age and above women with high stress levels
Exclusion Criteria:
- who do not want to participate
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: breathing exercise group
breathing exercise group: make breathing exercise for 12 weeks
|
For 12 weeks they will do kumbaka breathing exercise for 5 minutes twice a day in the morning and evening
Other Names:
|
|
No Intervention: control group
control group: continue standart treartment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
anxiety state scale
Time Frame: 12 weeks
|
anxiety state scale point min:0 max:63)
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Gürcan Solmaz, PhD, İstanbulUniversity-Cerrahpaşa
- Study Chair: Gürcan Solmaz, PhD, Istanbul University-Cerrahpasa
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)
November 1, 2023
Primary Completion (Actual)
April 30, 2024
Study Completion (Actual)
April 30, 2024
Study Registration Dates
First Submitted
March 12, 2024
First Submitted That Met QC Criteria
March 12, 2024
First Posted (Actual)
March 19, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 4, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Istanbul University-Cerrahpaşa
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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