ExerciseNCT06613061
Effects of Breathing Exercises on Pain, Fatigue, and Anxiety Levels in Women Receiving Brachytherapy
A study testing Breathing exercise in people with Exercise, run by Amasya University at 1 site in Turkey (Türkiye).
Trial summary
Breathing exercises are one of the most useful techniques to reduce stress and anxiety. The aim of this study is to determine the effects of breathing exercises on pain, anxiety and fatigue in patients receiving brachytherapy treatment. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Exercise
- What is being tested?
- Breathing exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Aug 2024to 11 May 2025
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being over 18 years old
- Being willing to participate in the study
- Being able to speak and understand Turkish
Who cannot join
- Having a malignancy related to the respiratory system (bronchus or lung)
- Having chest pain
- Having done box breathing and diaphragm breathing exercises/receiving training before
- Having cognitive dysfunction
- Not giving consent to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Breathing Exercise Women Receiving Brachytherapy
Breathing exercises are one of the most useful techniques to reduce stress and anxiety. The aim of this study is to determine the effects of breathing exercises on pain, anxiety and fatigue in patients receiving brachytherapy treatment.
Read the detailed description
Introduction: Breathing exercises are one of the most useful techniques to reduce stress and anxiety.
Objective: The aim of this study is to determine the effects of breathing exercises on pain, anxiety and fatigue in patients receiving brachytherapy treatment.
Method: The sample of the study will consist of 56 women who applied to the Brachytherapy Unit of a training and research hospital. The research data will be collected using the Introductory Information Form, Numerical Pain Scale, Beck Anxiety Inventory and Piper Fatigue Scale. Although studies have been conducted in different areas regarding breathing exercises, no study has been found in our country regarding the effects of breathing exercises on patients receiving brachytherapy. Therefore, this study will determine the effects of breathing exercises on pain, anxiety and fatigue in patients receiving brachytherapy treatment and contribute to the literature.
Conclusion: It is thought that breathing exercises will be beneficial in reducing physical and psychological symptoms.
- Conditions
- Exercise
- Being tested
- Breathing exercise
- Keywords
- radiothreapy
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing exerciseOther
The researcher has a breathing exercise certificate. In our study, the breathing exercise application consists of three stages: box breathing, sigh breathing and diaphragm breathing.
Patients will be asked to continue the breathing exercise application for 2 weeks and will be reminded to do the breathing exercises. Box and sigh breathing will be done 3 times a day (morning, noon and evening) every day for 2 weeks. Diaphragm breathing exercise will be applied for 2 minutes in the first week and 4 minutes in the second week.
| Study group | Role | What they receive |
|---|---|---|
| Experimental (breathing exercise) | Experimental | The researcher has a breathing exercise certificate. In our study, the breathing exercise application consists of three stages: box breathing, sigh breathing and diaphragm breathing.
Patients will be asked to continue the breathing exercise application for 2 weeks and will be reminded to do the breathing exercises. Box and sigh breathing will be done 3 times a day (morning, noon and evening) every day for 2 weeks. Diaphragm breathing exercise will be applied for 2 minutes in the first week and 4 minutes in the second week. Receives: Other: Breathing exercise |
| Control | No intervention | The control group will receive standard care. No intervention will be applied to these patients during the follow-up period, only data collection forms will be applied. Data collection forms will be collected in the same time period as the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical pain scale
Numerical pain scale: The numerical pain scale is a one-dimensional scale and the expressions "no pain" and "unbearable pain" are located at both ends of the figure. There are values between 0-10 on the scale at equal intervals and the patient marks them according to the level of pain.The scale scores between 0-10. The high total score indicates the high pain level experienced by the person.
Measured: Two week
Beck Anxiety Inventory
The Beck Anxiety Inventory (BAI) is a Likert-type assessment scale consisting of 21 items and scored between 0-3, designed to measure the frequency of anxiety symptoms experienced by the individual. Individuals rate each item by giving a score between 0-3 to determine how uncomfortable they have felt "over the past week, including the day of the application". The scale scores between 0-63. The high total score indicates the high level of anxiety experienced by the person
Measured: Two week
Piper Fatigue Scale
Piper Fatigue Scale (PFS): The PFS consists of 22 questions and evaluates fatigue perception subjectively. It has four sub-dimensions: the behavior/severity sub-dimension, which evaluates the effect and severity of fatigue on daily life activities; the affective sub-dimension, which covers the emotional meaning attributed to fatigue; the sensory sub-dimension, which reflects the mental, physical and emotional symptoms of fatigue; and the cognitive/spiritual sub-dimension, which reflects the degree to which fatigue affects cognitive functions and mood. The total score of the scale varies between 0 and 10. A score of 0 indicates no fatigue, 1-3 indicates mild fatigue, 4-6 indicates moderate fatigue, and 7-10 indicates severe fatigue.
Measured: Two week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start19 Aug 2024
- Primary completion10 May 2025
- Study completion11 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neşe Uysal, Amasya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613061
- Sponsor's protocol ID
- AmasyaU-NU-689
- Status last verified
- May 2025
- First submitted
- 23 Sep 2024
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breathing Exercise Women Receiving Brachytherapy
- ClinicalTrials.gov ID
- NCT06613061
- Acronym / sponsor ID
- AmasyaU-NU-689
- Conditions
- Exercise
- Keywords
- radiothreapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 10 May 2025 (actual)
- Study completion
- 11 May 2025 (actual)
- First posted
- 25 Sep 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.
Breathing exercises are one of the most useful techniques to reduce stress and anxiety. The aim of this study is to determine the effects of breathing exercises on pain, anxiety and fatigue in patients receiving brachytherapy treatment.
Detailed description
Introduction: Breathing exercises are one of the most useful techniques to reduce stress and anxiety.
Objective: The aim of this study is to determine the effects of breathing exercises on pain, anxiety and fatigue in patients receiving brachytherapy treatment.
Method: The sample of the study will consist of 56 women who applied to the Brachytherapy Unit of a training and research hospital. The research data will be collected using the Introductory Information Form, Numerical Pain Scale, Beck Anxiety Inventory and Piper Fatigue Scale. Although studies have been conducted in different areas regarding breathing exercises, no study has been found in our country regarding the effects of breathing exercises on patients receiving brachytherapy. Therefore, this study will determine the effects of breathing exercises on pain, anxiety and fatigue in patients receiving brachytherapy treatment and contribute to the literature.
Conclusion: It is thought that breathing exercises will be beneficial in reducing physical and psychological symptoms.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental (breathing exercise) | Experimental | Other: Breathing exerciseThe researcher has a breathing exercise certificate. In our study, the breathing exercise application consists of three stages: box breathing, sigh breathing and diaphragm breathing. Patients will be asked to continue the breathing exercise application for 2 weeks and will be reminded to do the breathing exercises. Box and sigh breathing will be done 3 times a day (morning, noon and evening) every day for 2 weeks. Diaphragm breathing exercise will be applied for 2 minutes in the first week and 4 minutes in the second week. |
| Control | No intervention | –The control group will receive standard care. No intervention will be applied to these patients during the follow-up period, only data collection forms will be applied. Data collection forms will be collected in the same time period as the intervention group. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being over 18 years old
- Being willing to participate in the study
- Being able to speak and understand Turkish
Key exclusion criteria (5 listed)
- Having a malignancy related to the respiratory system (bronchus or lung)
- Having chest pain
- Having done box breathing and diaphragm breathing exercises/receiving training before
- Having cognitive dysfunction
- Not giving consent to participate in the study
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 exerciseThe researcher has a breathing exercise certificate. In our study, the breathing exercise application consists of three stages: box breathing, sigh breathing and diaphragm breathing. Patients will be asked to continue the breathing exercise application for 2 weeks and will be reminded to do the breathing exercises. Box and sigh breathing will be done 3 times a day (morning, noon and evening) every day for 2 weeks. Diaphragm breathing exercise will be applied for 2 minutes in the first week and 4 minutes in the second week. | Other | Experimental (breathing exercise) |
Primary outcome
Numerical pain scale
Time frame: Two week
Numerical pain scale: The numerical pain scale is a one-dimensional scale and the expressions "no pain" and "unbearable pain" are located at both ends of the figure. There are values between 0-10 on the scale at equal intervals and the patient marks them according to the level of pain.The scale scores between 0-10. The high total score indicates the high pain level experienced by the person.
Beck Anxiety Inventory
Time frame: Two week
The Beck Anxiety Inventory (BAI) is a Likert-type assessment scale consisting of 21 items and scored between 0-3, designed to measure the frequency of anxiety symptoms experienced by the individual. Individuals rate each item by giving a score between 0-3 to determine how uncomfortable they have felt "over the past week, including the day of the application". The scale scores between 0-63. The high total score indicates the high level of anxiety experienced by the person
Piper Fatigue Scale
Time frame: Two week
Piper Fatigue Scale (PFS): The PFS consists of 22 questions and evaluates fatigue perception subjectively. It has four sub-dimensions: the behavior/severity sub-dimension, which evaluates the effect and severity of fatigue on daily life activities; the affective sub-dimension, which covers the emotional meaning attributed to fatigue; the sensory sub-dimension, which reflects the mental, physical and emotional symptoms of fatigue; and the cognitive/spiritual sub-dimension, which reflects the degree to which fatigue affects cognitive functions and mood. The total score of the scale varies between 0 and 10. A score of 0 indicates no fatigue, 1-3 indicates mild fatigue, 4-6 indicates moderate fatigue, and 7-10 indicates severe fatigue.
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 14 May 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Exercise, run by Amasya University 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 3 inclusion and 5 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 14 May 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?
Numerical pain scale (time frame: Two week). The study lists 3 primary outcomes in all. 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 14 May 2025.