Women Receiving ChemotherapyNCT06318455
The Effect of Breathing Exercise on Sleep and Stress Levels in Women With Breast Cancer Receiving Chemotherapy Treatment
A study testing Breathing exercise in people with Women Receiving Chemotherapy and Poor Quality Sleep, run by University of Yalova at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Women Receiving Chemotherapy, Poor Quality Sleep, Breast Cancer Stage II
- What is being tested?
- Breathing exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women receiving chemotherapy women with poor sleep quality 18 years of age and above women with high stress levels
Who cannot join
- who do not want to participate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of İstanbul-cerrahpaşa (IUC)
Istanbul
About this study
Official title: 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.
Read the 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.
- Being tested
- Breathing exercise
- Keywords
- chemotherapy, sleep quality, breathing exercise
- Medical subject headings
- Breast Neoplasms, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing exerciseOther
Also called breathing and control group
For 12 weeks they will do kumbaka breathing exercise for 5 minutes twice a day in the morning and evening
| Study group | Role | What they receive |
|---|---|---|
| breathing exercise group | Experimental | breathing exercise group: make breathing exercise for 12 weeks Receives: Other: Breathing exercise |
| control group | No intervention | control group: continue standart treartment |
What is being measured
The primary outcome is the main question the study is designed to answer.
anxiety state scale
anxiety state scale point min:0 max:63)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start1 Nov 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women Receiving ChemotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Yalova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gürcan Solmaz, University of Yalova
- Investigators
- Gürcan Solmaz, PhD, Study chair, İstanbulUniversity-CerrahpaşaGürcan Solmaz, PhD, Study chair, İstanbul University-Cerrahpaşa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318455
- Sponsor's protocol ID
- İstanbul University-Cerrahpaşa
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2024
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- İstanbul University-Cerrahpaşa
- ClinicalTrials.gov ID
- NCT06318455
- Acronym / sponsor ID
- İstanbul University-Cerrahpaşa
- Keywords
- chemotherapy, sleep quality, breathing exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of YalovaUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| breathing exercise group | Experimental | Other: Breathing exercisebreathing exercise group: make breathing exercise for 12 weeks |
| control group | No intervention | –control group: continue standart treartment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- women receiving chemotherapy women with poor sleep quality 18 years of age and above women with high stress levels
Key exclusion criteria (1 listed)
- who do not want to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathing exerciseAlso: breathing and control groupFor 12 weeks they will do kumbaka breathing exercise for 5 minutes twice a day in the morning and evening | Other | breathing exercise group |
Primary outcome
anxiety state scale
Time frame: 12 weeks
anxiety state scale point min:0 max:63)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gürcan Solmaz, PhD study chair
İstanbulUniversity-Cerrahpaşa
Gürcan Solmaz, PhD study chair
İstanbul University-Cerrahpaşa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing exercise in people with Women Receiving Chemotherapy and Poor Quality Sleep, run by University of Yalova at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anxiety state scale (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.