Breast CancerBREATH-RCTNCT07449273
Breathing Interventions for Postoperative Breast Surgery Patients
A study testing Pranayama Breathing Exercise and Pursed-Lip Breathing Exercise in people with Breast Cancer and Breast Surgery, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to evaluate the effects of pranayama and pursed-lip breathing exercises on postoperative pain, anxiety, and vital signs in patients undergoing breast surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Surgery, Postoperative Pain
- What is being tested?
- Pranayama Breathing Exercise and Pursed-Lip Breathing Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 May 2026to 27 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years and older
- Able to communicate effectively
- Patients undergoing elective surgery for the first time, including radical mastectomy, modified radical mastectomy, or simple mastectomy
Who cannot join
- Patients undergoing breast-conserving surgery
- Patients who develop any postoperative complications, such as bleeding or anesthesia-related complications
- Individuals with cognitive or mental impairments
- Patients who wish to withdraw from the study at any stage
- Patients with hearing or speech impairments
- Patients with a psychiatric diagnosis or those using psychiatric medications
- Patients unable to comply with breathing exercises
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
University of Health Sciences Haydarpasa Numune Training and Research Hospital
Istanbul, Istanbul, 34668
Gonca Akbaş, MSc, +90 531 271 6024, akbasgonca0@gmail.com
About this study
Official title: Effects of Pranayama and Pursed-lip Breathing Exercises on Pain, Anxiety and Vital Signs After Breast Surgery
This randomized controlled trial aims to evaluate the effects of pranayama and pursed-lip breathing exercises on postoperative pain, anxiety, and vital signs in patients undergoing breast surgery. Postoperative pain and anxiety are common problems that can negatively affect recovery, physiological stability, and overall well-being. Non-pharmacological interventions such as breathing exercises may help reduce these adverse outcomes and support recovery.
Participants will be randomly assigned to one of three groups: a pranayama breathing exercise group, a pursed-lip breathing exercise group, or a control group receiving routine postoperative care. Breathing exercises will be performed three times daily for five minutes. Outcomes including pain, anxiety, and vital signs will be measured at baseline (pretest), postoperative day 1, and postoperative day 2. The findings of this study are expected to provide evidence on the effectiveness of breathing exercises as supportive nursing interventions in the postoperative care of breast surgery patients.
Read the detailed description
This study is a randomized, controlled, pretest-posttest experimental trial designed to evaluate the effects of pranayama and pursed-lip breathing exercises on postoperative pain, anxiety, and vital signs in patients undergoing breast surgery.
Breast surgery patients frequently experience postoperative pain, anxiety, and alterations in physiological parameters such as blood pressure, heart rate, respiratory rate, and oxygen saturation. Although pharmacological management is commonly used, non-pharmacological complementary interventions may enhance recovery and improve patient comfort. Breathing exercises are low-cost, non-invasive interventions that may activate the parasympathetic nervous system, reduce stress responses, and improve oxygenation.
Participants will be recruited from the General Surgery Department of a tertiary hospital. Eligible patients aged 18 years and older who undergo elective radical mastectomy, modified radical mastectomy, or simple mastectomy will be included. After providing informed consent, participants will be randomly assigned using block randomization into one of three groups:
Pranayama Breathing Group (Nadi Shodhana technique)
Pursed-Lip Breathing Group
Control Group (routine postoperative care)
Intervention groups will receive breathing exercises starting at the 4th postoperative hour. Exercises will be performed three times daily for two consecutive days, each session lasting approximately five minutes. The pranayama group will perform alternate nostril breathing (Nadi Shodhana), while the pursed-lip group will perform controlled inhalation through the nose followed by prolonged exhalation through pursed lips. The control group will receive standard postoperative care without breathing exercises.
Primary and secondary outcomes will be assessed at baseline and after interventions. Pain intensity will be measured using the Visual Analog Scale (VAS). Anxiety levels will be evaluated using the State Anxiety Inventory (STAI-S). Vital signs including systolic and diastolic blood pressure, heart rate, respiratory rate, and oxygen saturation (SpO₂) will be recorded using standard clinical monitoring devices.
Data will be analyzed using appropriate statistical tests depending on distribution characteristics, including repeated measures ANOVA or non-parametric equivalents. The study aims to determine whether pranayama and pursed-lip breathing exercises significantly reduce postoperative pain and anxiety and improve physiological stability compared to routine care.
This trial is expected to contribute evidence regarding the effectiveness of structured breathing exercises as supportive nursing interventions in postoperative breast surgery care.
- Conditions
- Breast Cancer, Breast Surgery, Postoperative Pain, Anxiety
- Being tested
- Pranayama Breathing Exercise, Pursed-Lip Breathing Exercise
- Keywords
- Pranayama, Pursed-lip breathing, Breathing exercises, Non-pharmacological intervention, Postoperative care, Randomized controlled trial, Nursing intervention
- Medical subject headings
- Breast Neoplasms, Pain, Postoperative, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pranayama Breathing ExerciseBehavioural
Participants perform pranayama breathing exercises (Nadi Shodhana technique) starting at the 4th postoperative hour. The exercise is performed three times daily for two consecutive days. Each session lasts approximately five minutes and is administered in addition to routine postoperative care. The breathing technique involves slow, controlled inhalation and exhalation through alternate nostrils to improve respiratory function and relaxation.
Pursed-Lip Breathing ExerciseBehavioural
Participants perform pursed-lip breathing exercises starting at the 4th postoperative hour. The exercise is performed three times daily for two consecutive days, with each session lasting approximately five minutes. Participants inhale slowly through the nose and exhale through pursed lips to prolong exhalation and improve ventilation, in addition to routine postoperative care.
| Study group | Role | What they receive |
|---|---|---|
| Pranayama Breathing Group | Experimental | Participants in this group will perform pranayama breathing exercises (Nadi Shodhana technique) starting at the 4th postoperative hour. The exercises will be performed three times daily for two consecutive days, with each session lasting approximately five minutes, in addition to routine postoperative care. Receives: Behavioral: Pranayama Breathing Exercise |
| Pursed-Lip Breathing Group | Experimental | Participants in this group will perform pursed-lip breathing exercises starting at the 4th postoperative hour. The exercises will be performed three times daily for two consecutive days, with each session lasting approximately five minutes, in addition to routine postoperative care. Receives: Behavioral: Pursed-Lip Breathing Exercise |
| Control Group | No intervention | Participants in this group will receive routine postoperative care without any breathing exercise intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Level
Pain intensity will be assessed using the Visual Analog Scale (VAS), a 10-centimeter scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain." Higher scores represent greater pain intensity. The scale will be administered on postoperative day 1 and postoperative day 2.
Measured: Postoperative day 1, and postoperative day 2.
Secondary outcomes (5)
Postoperative Anxiety Level
Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI-State Form), a 20-item self-report questionnaire with total scores ranging from 20 to 80. Higher scores indicate greater levels of anxiety. The scale will be administered on postoperative day 1 and postoperative day 2.
Measured: postoperative day 1, and postoperative day 2.
Changes in Heart Rate
Heart rate (beats per minute) will be measured manually by counting the radial pulse for one minute. Higher values indicate increased heart rate.
Measured: postoperative day 1, and postoperative day 2.
Changes in Oxygen Saturation
Oxygen saturation (SpO₂, %) will be measured using pulse oximetry. Higher values indicate better oxygenation status.
Measured: Postoperative day 1 and postoperative day 2.
Changes in Blood Pressure
Systolic and diastolic blood pressure (mmHg) will be measured manually using a sphygmomanometer and stethoscope. Higher systolic and diastolic values indicate increased blood pressure.
Measured: Postoperative day 1 and postoperative day 2.
Changes in Respiratory Rate
Respiratory rate (breaths per minute) will be measured manually by observing chest movements and counting respirations for one minute. Higher values indicate increased respiratory rate.
Measured: Postoperative day 1 and postoperative day 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start13 May 2026
- Primary completion27 Feb 2027 (estimated)
- Study completion27 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to three parallel groups: a pranayama breathing exercise group, a pursed-lip breathing exercise group, and a control group receiving routine postoperative care.
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özge İşeri, Ondokuz Mayıs University
- Investigators
- Özge İşeri, Assistant Professor, Principal investigator, Ondokuz Mayıs University, Faculty of Health Sciences, Department of Nursing, Samsun, Türkiye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449273
- Sponsor's protocol ID
- 2025/899
- Acronym
- BREATH-RCT
- Status last verified
- Oct 2026
- First submitted
- 25 Feb 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan for sharing individual participant data has not yet been determined. Data sharing decisions will be made after study completion in accordance with institutional policies and ethical considerations.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pranayama and Pursed-lip Breathing Exercises on Pain, Anxiety and Vital Signs After Breast Surgery
- ClinicalTrials.gov ID
- NCT07449273
- Acronym / sponsor ID
- BREATH-RCT / 2025/899
- Conditions
- Breast Cancer, Breast Surgery, Postoperative Pain, Anxiety
- Keywords
- Pranayama, Pursed-lip breathing, Breathing exercises, Non-pharmacological intervention, Postoperative care, Randomized controlled trial, Nursing intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 13 May 2026 (actual)
- Primary completion
- 27 Feb 2027 (estimated)
- Study completion
- 27 Apr 2027 (estimated)
- First posted
- 4 Mar 2026 (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.
This randomized controlled trial aims to evaluate the effects of pranayama and pursed-lip breathing exercises on postoperative pain, anxiety, and vital signs in patients undergoing breast surgery. Postoperative pain and anxiety are common problems that can negatively affect recovery, physiological stability, and overall well-being. Non-pharmacological interventions such as breathing exercises may help reduce these adverse outcomes and support recovery.
Participants will be randomly assigned to one of three groups: a pranayama breathing exercise group, a pursed-lip breathing exercise group, or a control group receiving routine postoperative care. Breathing exercises will be performed three times daily for five minutes. Outcomes including pain, anxiety, and vital signs will be measured at baseline (pretest), postoperative day 1, and postoperative day 2. The findings of this study are expected to provide evidence on the effectiveness of breathing exercises as supportive nursing interventions in the postoperative care of breast surgery patients.
Detailed description
This study is a randomized, controlled, pretest-posttest experimental trial designed to evaluate the effects of pranayama and pursed-lip breathing exercises on postoperative pain, anxiety, and vital signs in patients undergoing breast surgery.
Breast surgery patients frequently experience postoperative pain, anxiety, and alterations in physiological parameters such as blood pressure, heart rate, respiratory rate, and oxygen saturation. Although pharmacological management is commonly used, non-pharmacological complementary interventions may enhance recovery and improve patient comfort. Breathing exercises are low-cost, non-invasive interventions that may activate the parasympathetic nervous system, reduce stress responses, and improve oxygenation.
Participants will be recruited from the General Surgery Department of a tertiary hospital. Eligible patients aged 18 years and older who undergo elective radical mastectomy, modified radical mastectomy, or simple mastectomy will be included. After providing informed consent, participants will be randomly assigned using block randomization into one of three groups:
Pranayama Breathing Group (Nadi Shodhana technique)
Pursed-Lip Breathing Group
Control Group (routine postoperative care)
Intervention groups will receive breathing exercises starting at the 4th postoperative hour. Exercises will be performed three times daily for two consecutive days, each session lasting approximately five minutes. The pranayama group will perform alternate nostril breathing (Nadi Shodhana), while the pursed-lip group will perform controlled inhalation through the nose followed by prolonged exhalation through pursed lips. The control group will receive standard postoperative care without breathing exercises.
Primary and secondary outcomes will be assessed at baseline and after interventions. Pain intensity will be measured using the Visual Analog Scale (VAS). Anxiety levels will be evaluated using the State Anxiety Inventory (STAI-S). Vital signs including systolic and diastolic blood pressure, heart rate, respiratory rate, and oxygen saturation (SpO₂) will be recorded using standard clinical monitoring devices.
Data will be analyzed using appropriate statistical tests depending on distribution characteristics, including repeated measures ANOVA or non-parametric equivalents. The study aims to determine whether pranayama and pursed-lip breathing exercises significantly reduce postoperative pain and anxiety and improve physiological stability compared to routine care.
This trial is expected to contribute evidence regarding the effectiveness of structured breathing exercises as supportive nursing interventions in postoperative breast surgery care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to three parallel groups: a pranayama breathing exercise group, a pursed-lip breathing exercise group, and a control group receiving routine postoperative care.
| Arm | Type | Receives |
|---|---|---|
| Pranayama Breathing Group | Experimental | Behavioral: Pranayama Breathing ExerciseParticipants in this group will perform pranayama breathing exercises (Nadi Shodhana technique) starting at the 4th postoperative hour. The exercises will be performed three times daily for two consecutive days, with each session lasting approximately five minutes, in addition to routine postoperative care. |
| Pursed-Lip Breathing Group | Experimental | Behavioral: Pursed-Lip Breathing ExerciseParticipants in this group will perform pursed-lip breathing exercises starting at the 4th postoperative hour. The exercises will be performed three times daily for two consecutive days, with each session lasting approximately five minutes, in addition to routine postoperative care. |
| Control Group | No intervention | –Participants in this group will receive routine postoperative care without any breathing exercise intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 years and older
- Able to communicate effectively
- Patients undergoing elective surgery for the first time, including radical mastectomy, modified radical mastectomy, or simple mastectomy
Key exclusion criteria (7 listed)
- Patients undergoing breast-conserving surgery
- Patients who develop any postoperative complications, such as bleeding or anesthesia-related complications
- Individuals with cognitive or mental impairments
- Patients who wish to withdraw from the study at any stage
- Patients with hearing or speech impairments
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 |
|---|---|---|
| Pranayama Breathing ExerciseParticipants perform pranayama breathing exercises (Nadi Shodhana technique) starting at the 4th postoperative hour. The exercise is performed three times daily for two consecutive days. Each session lasts approximately five minutes and is administered in addition to routine postoperative care. The breathing technique involves slow, controlled inhalation and exhalation through alternate nostrils to improve respiratory function and relaxation. | Behavioural | Pranayama Breathing Group |
| Pursed-Lip Breathing ExerciseParticipants perform pursed-lip breathing exercises starting at the 4th postoperative hour. The exercise is performed three times daily for two consecutive days, with each session lasting approximately five minutes. Participants inhale slowly through the nose and exhale through pursed lips to prolong exhalation and improve ventilation, in addition to routine postoperative care. | Behavioural | Pursed-Lip Breathing Group |
Primary outcome
Postoperative Pain Level
Time frame: Postoperative day 1, and postoperative day 2.
Pain intensity will be assessed using the Visual Analog Scale (VAS), a 10-centimeter scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain." Higher scores represent greater pain intensity. The scale will be administered on postoperative day 1 and postoperative day 2.
5 secondary outcomes
Postoperative Anxiety Level
Time frame: postoperative day 1, and postoperative day 2.
Changes in Heart Rate
Time frame: postoperative day 1, and postoperative day 2.
Changes in Oxygen Saturation
Time frame: Postoperative day 1 and postoperative day 2.
Changes in Blood Pressure
Time frame: Postoperative day 1 and postoperative day 2.
Changes in Respiratory Rate
Time frame: Postoperative day 1 and postoperative day 2.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: Undecided. The plan for sharing individual participant data has not yet been determined. Data sharing decisions will be made after study completion in accordance with institutional policies and ethical considerations.
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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.
Özge İşeri, Assistant Professor principal investigator
Ondokuz Mayıs University, Faculty of Health Sciences, Department of Nursing, Samsun, Türkiye
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pranayama Breathing Exercise and Pursed-Lip Breathing Exercise in people with Breast Cancer and Breast Surgery, run by Ondokuz Mayıs 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 7 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: looking for participants now, as of the sponsor's last update on 5 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gonca AKBAŞ, MSc (5312716024 ext. (216) 5472600, akbasgonca0@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Level (time frame: Postoperative day 1, and postoperative day 2.). 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 5 Oct 2026.