Breathing Interventions for Postoperative Breast Surgery Patients (BREATH-RCT)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Surgery; Breast Cancer; Postoperative Pain; Anxiety
• Intervention / Treatment: Behavioral: Pranayama Breathing Exercise; Behavioral: Pursed-Lip Breathing Exercise

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 Type: Interventional
• Enrollment (Estimated): 126
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gonca AKBAŞ, MSc; Phone Number: (216) 5472600 5312716024; Email: akbasgonca0@gmail.com
• Study Contact Backup: Name: Özge İşeri, Assistant Professor; Phone Number: 3623121919 5433997496; Email: ozgepekiniseri@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pranayama Breathing Group; 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.	Behavioral: Pranayama Breathing Exercise; 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.
Experimental: Pursed-Lip Breathing Group; 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.	Behavioral: Pursed-Lip Breathing Exercise; 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.
No Intervention: Control Group; Participants in this group will receive routine postoperative care without any breathing exercise intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Postoperative day 1, and postoperative day 2.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Postoperative day 1 and postoperative day 2.

Collaborators and Investigators

• Sponsor: Ondokuz Mayıs University
• Investigators: Principal Investigator: Özge İşeri, Assistant Professor, Ondokuz Mayıs University, Faculty of Health Sciences, Department of Nursing, Samsun, Türkiye

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): February 27, 2027
• Study Completion (Estimated): April 27, 2027

Study Registration Dates

• First Submitted: February 25, 2026
• First Submitted That Met QC Criteria: March 3, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Postoperative care; Pranayama; Breathing exercises; Non-pharmacological intervention; Nursing intervention; Pursed-lip breathing
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Mental Disorders; Postoperative Complications; Pathologic Processes; Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Signs and Symptoms; Pain, Postoperative; Anxiety Disorders; Breast Neoplasms
• Other Study ID Numbers: 2025/899

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No