NCT07449273

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
10mo left

Started May 2026

Shorter than P25 for not_applicable breast-cancer

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress13%
May 2026Apr 2027

First Submitted

Initial submission to the registry

February 25, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2027

Last Updated

May 11, 2026

Status Verified

May 1, 2026

Enrollment Period

10 months

First QC Date

February 25, 2026

Last Update Submit

May 7, 2026

Conditions

Keywords

PranayamaPursed-lip breathingBreathing exercisesNon-pharmacological interventionPostoperative careRandomized controlled trialNursing intervention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Postoperative Anxiety Level

    postoperative day 1, and postoperative day 2.

  • Changes in Heart Rate

    postoperative day 1, and postoperative day 2.

  • Changes in Oxygen Saturation

    Postoperative day 1 and postoperative day 2.

  • Changes in Blood Pressure

    Postoperative day 1 and postoperative day 2.

  • Changes in Respiratory Rate

    Postoperative day 1 and postoperative day 2.

Study Arms (3)

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.

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.

Behavioral: Pursed-Lip Breathing Exercise

Control Group

NO INTERVENTION

Participants in this group will receive routine postoperative care without any breathing exercise intervention.

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.

Pranayama Breathing Group

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.

Pursed-Lip Breathing Group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly female participants are eligible for this study, as the research focuses on women undergoing breast surgery.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast NeoplasmsPain, PostoperativeAnxiety Disorders

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsMental Disorders

Study Officials

  • Özge İşeri, Assistant Professor

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gonca AKBAŞ, MSc

CONTACT

Özge İşeri, Assistant Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Blinding was not feasible due to the nature of the breathing exercise interventions.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Surgical Nursing

Study Record Dates

First Submitted

February 25, 2026

First Posted

March 4, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

February 27, 2027

Study Completion (Estimated)

April 27, 2027

Last Updated

May 11, 2026

Record last verified: 2026-05