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临床试验/NCT07449273
NCT07449273尚未招募不适用

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

Ondokuz Mayıs University0 个研究点目标入组 126 人开始时间: 2026年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
126
主要终点
Postoperative Pain Level

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Pranayama Breathing Exercise (Behavioral)

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.

干预措施: Pursed-Lip Breathing Exercise (Behavioral)

Control Group

No Intervention

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

结局指标

主要结局

Postoperative Pain Level

时间窗: 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.

次要结局

  • 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.)

研究者

发起方
Ondokuz Mayıs University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Özge İşeri

Assistant Professor of Surgical Nursing

Ondokuz Mayıs University

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