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NCT Number: NCT07449273

Breathing Interventions for Postoperative Breast Surgery Patients

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pranayama Breathing Exercise

Behavioral

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 Exercise

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Postoperative Anxiety Level

    Time frame: postoperative 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.

  2. Changes in Heart Rate

    Time frame: postoperative 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.

  3. Changes in Oxygen Saturation

    Time frame: Postoperative day 1 and postoperative day 2.

    Oxygen saturation (SpO₂, %) will be measured using pulse oximetry. Higher values indicate better oxygenation status.

  4. Changes in Blood Pressure

    Time frame: Postoperative 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.

  5. Changes in Respiratory Rate

    Time frame: Postoperative 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gonca AKBAŞ, MSc

CONTACT

[email protected]

5312716024 ext. (216) 5472600

Özge İşeri, Assistant Professor

CONTACT

[email protected]

5433997496 ext. 3623121919

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

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

Acronym: BREATH-RCT

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 4, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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