Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
FEMALE
ID07494955

Effect of a 5-Minute Mindfulness-Based Breathing Exercise Before Spinal Anesthesia on Hemodynamic Response in Elective Cesarean Section: A Prospective Randomized Controlled Trial

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

150

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Spinal anesthesia-induced hypotension is a common and significant complication affecting up to 50-80% of pregnant women undergoing elective cesarean section. This trial evaluates whether a brief 5-minute mindfulness-based breathing exercise given just before spinal anesthesia can influence blood pressure changes during surgery. The study compares this breathing technique to standard care in pregnant women aged 18 to 45 years scheduled for elective cesarean delivery. Participants will be randomly assigned to either perform the mindfulness-based breathing exercise or receive standard preoperative care. The breathing exercise involves slow diaphragmatic breathing at about six breaths per minute, guided by a trained anesthesiologist or nurse, with mindful repetition of the phrase "My body is relaxing as I exhale." Both groups receive spinal anesthesia with specific medications, and careful monitoring of heart rate and blood pressure is performed. During the study, participants will be closely observed for changes in systolic blood pressure and heart rate within 10 minutes after spinal anesthesia. Anxiety levels, incidence of early hypotension, and medication use to support blood pressure will also be measured. The trial includes standard monitoring such as ECG and oxygen saturation, with safety and response data collected throughout the procedure. Participants' involvement includes a short breathing exercise or equivalent wait time before anesthesia, with follow-up assessments during surgery.

CONDITIONS

Brief 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 more
  • American Society of Anesthesiologists (ASA) physical status II
  • Scheduled for elective cesarean section under spinal anesthesia
  • Body mass index (BMI) of 35 kg/m2 or less
  • Ability to understand 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 (e.g., gestational hypertension, preeclampsia, eclampsia, HELLP syndrome)
  • Placenta previa, placental abruption, or active antepartum bleeding
  • Multiple pregnancy
  • Contraindications to spinal anesthesia
  • Failed spinal anesthesia requiring general anesthesia
  • Chronic hypertension or hypotension
  • Known cardiac diseases such as arrhythmia, valvular disease, or cardiomyopathy
  • Diabetes with autonomic neuropathy
  • Thyroid dysfunction
  • Chronic lung disease affecting breathing
  • BMI 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 opioids
  • Diagnosed psychiatric illnesses including anxiety, panic disorder, or major depression
  • Regular use of psychiatric medications
  • Cognitive or communication impairments
  • Difficulty following or performing the breathing exercise
  • Prior regular practice of meditation, yoga, or mindfulness training

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Day of surgery

Participants receive either a 5-minute mindfulness-based breathing exercise immediately before spinal anesthesia or standard preoperative care without breathing exercises. All participants undergo spinal anesthesia for elective cesarean section.

1 visit in the operating room

Post-operative Follow-up

Duration - Up to 10 minutes following spinal anesthesia induction

Participants are monitored for hemodynamic responses and safety outcomes up to 10 minutes after spinal anesthesia induction, including blood pressure and heart rate changes.

Monitoring during the surgery visit

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

A

aysenur dostbil, PROF. DR.

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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