Menu
Not yet recruiting NCT07449273

Breathing Interventions for Postoperative Breast Surgery Patients

No phase Interventional Breast Cancer Breast Surgery Postoperative Pain Anxiety

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pranayama Breathing Exercise, Pursed-Lip Breathing Exercise.
Who it may be relevant to
Registry conditions: Breast Cancer, Breast Surgery, Postoperative Pain, Anxiety. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • 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.
  • 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.

Primary outcome measures

  • Postoperative Pain Level [Time frame: Postoperative day 1, and postoperative day 2.]
Secondary outcome measures (5)
  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07449273 · 2025/899

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗