What is the mindfulness-based breathing exercise studying for pregnant women undergoing cesarean section?

This clinical trial is studying whether a short mindfulness-based breathing exercise given before spinal anesthesia can affect blood pressure changes during elective cesarean section. Researchers want to see if this breathing technique can reduce the risk of low blood pressure, a common complication. The study is led by Aysenur Dostbil and conducted under strict medical guidelines.

Who may be eligible for this hypotension clinical trial?

Women aged 18 to 45 who are pregnant with a single baby and scheduled for an elective cesarean section may be eligible. Participants must be able to perform the breathing exercise and not have certain medical conditions like hypertension, heart disease, psychiatric illness, or take specific medications. Please review eligibility criteria for more details.

Is there any cost to participate in this hypotension clinical trial?

Study-related care, including the breathing exercise and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants can expect the study procedures to be provided free of charge during their hospital stay.

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

Research Sites

N/A

Total Duration

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

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

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

Research Team

esra dilara ayber, MD

aysenur dostbil, PROF. DR.

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