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Breathing Interventions for Postoperative Breast Surgery Patients

Effects of Pranayama and Pursed-lip Breathing Exercises on Pain, Anxiety and Vital Signs After Breast Surgery

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07449273
Acronym
BREATH-RCT
Enrollment
126
Registered
2026-03-04
Start date
2026-02-27
Completion date
2027-04-27
Last updated
2026-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Brief 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. 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.

Interventions

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.

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.

Sponsors

Ondokuz Mayıs University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

Blinding was not feasible due to the nature of the breathing exercise interventions.

Intervention 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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Pain LevelPostoperative 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.

Secondary

MeasureTime frameDescription
Postoperative Anxiety Levelpostoperative day 1, and postoperative day 2.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.
Changes in Heart Ratepostoperative day 1, and postoperative day 2.Heart rate (beats per minute) will be measured manually by counting the radial pulse for one minute. Higher values indicate increased heart rate.
Changes in Oxygen SaturationPostoperative day 1 and postoperative day 2.Oxygen saturation (SpO₂, %) will be measured using pulse oximetry. Higher values indicate better oxygenation status.
Changes in Blood PressurePostoperative day 1 and postoperative day 2.Systolic and diastolic blood pressure (mmHg) will be measured manually using a sphygmomanometer and stethoscope. Higher systolic and diastolic values indicate increased blood pressure.
Changes in Respiratory RatePostoperative day 1 and postoperative day 2.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.

Contacts

CONTACTGonca AKBAŞ, MSc
akbasgonca0@gmail.com5312716024
CONTACTÖzge İşeri, Assistant Professor
ozgepekiniseri@gmail.com5433997496
PRINCIPAL_INVESTIGATORÖzge İşeri, Assistant Professor

Ondokuz Mayıs University, Faculty of Health Sciences, Department of Nursing, Samsun, Türkiye

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026