Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
FEMALE
NCT07494955

"Effect of Pre-Spinal Mindfulness-Based Breathing Exercise on Hemodynamic Response in Elective Cesarean Section"

Led by Aysenur Dostbil · Updated on 2026-04-01

150

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Spinal anesthesia-induced hypotension is one of the most frequent and clinically significant complications of obstetric anesthesia, occurring in up to 50-80% of parturients undergoing elective cesarean section. Preoperative anxiety has been shown to potentiate hemodynamic instability through autonomic nervous system activation, thereby increasing susceptibility to spinal hypotension. This prospective, randomized, controlled trial aims to evaluate the effect of a standardized 5-minute mindfulness-based breathing exercise administered immediately prior to spinal anesthesia on the hemodynamic response in pregnant women scheduled for elective cesarean section. Eligible participants will be randomized in a 1:1 ratio into two parallel groups: the Mindfulness-Based Breathing Exercise Group and the Control Group receiving standard preoperative care. The breathing intervention consists of slow diaphragmatic breathing at a rate of approximately 6 breaths per minute (4-second inhalation through the nose, 6-second exhalation through the mouth), guided by a standardized script delivered by a trained anesthesiologist or nurse. Participants in the intervention group will be instructed to silently repeat the phrase "My body is relaxing as I exhale" with each exhalation, incorporating a mindfulness component. The primary outcome is the maximum decrease in systolic arterial pressure (SAP) within the first 10 minutes following spinal anesthesia induction. Secondary outcomes include preoperative state anxiety scores (STAI-5), early spinal hypotension incidence, heart rate changes, and vasopressor requirements. The study will be conducted at Atatürk University Faculty of Medicine, Department of Anesthesiology and Reanimation, Erzurum, Turkey, in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines.

CONDITIONS

Official Title

"Effect of Pre-Spinal Mindfulness-Based Breathing Exercise on Hemodynamic Response in Elective Cesarean Section"

Who Can Participate

Age: 18Years - 45Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant women aged 18 to 45 years
  • Singleton pregnancy
  • Gestational age of 37 weeks or greater
  • American Society of Anesthesiologists (ASA) physical status classification II
  • Scheduled for elective cesarean section under spinal anesthesia
  • Body mass index (BMI) of 35 kg/m2 or less
  • Ability to understand verbal instructions and perform the breathing exercise
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • Emergency cesarean section
  • Hypertensive disorders of pregnancy including gestational hypertension, preeclampsia, eclampsia, HELLP syndrome
  • Placenta previa, placental abruption, or active antepartum hemorrhage
  • Multiple pregnancy
  • Contraindications to spinal anesthesia
  • Failed spinal anesthesia requiring conversion to general anesthesia
  • Chronic hypertension or chronic hypotension
  • Known cardiac diseases such as arrhythmia, valvular disease, or cardiomyopathy
  • Diabetes mellitus with autonomic neuropathy
  • Thyroid dysfunction
  • Chronic pulmonary disease affecting breathing pattern
  • Body mass index greater than 35 kg/m2
  • Regular use of beta-blockers, calcium channel blockers, alpha-agonists, or alpha-antagonists
  • Regular use of anxiolytics, antidepressants, sedatives, or chronic opioids
  • Diagnosed anxiety disorder, panic disorder, major depressive disorder, or other psychiatric illness
  • Regular use of psychiatric medications
  • Cognitive impairment or communication difficulties
  • Attention or compliance problems preventing proper performance of the breathing exercise
  • Prior regular practice of meditation, yoga, or mindfulness-based training

AI-Screening

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Trial Site Locations

Total: 1 location

1

Atatürk University Research Hospital

Erzurum, Turkey (Türkiye), 25240

Actively Recruiting

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Research Team

E

esra dilara ayber, MD

CONTACT

A

aysenur dostbil, PROF. DR.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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