Mindfulness-based breathing before spinal anesthesia for elective cesarean delivery

"The Effect of a 5-Minute Mindfulness-Based Breathing Exercise Administered Prior to Spinal Anesthesia on Hemodynamic Response in Patients Undergoing Elective Cesarean Section: A Prospective Randomized Controlled Trial"

This trial will test whether a 5-minute mindfulness slow-breathing exercise just before spinal anesthesia can reduce blood pressure drops and anxiety in pregnant women having elective cesarean delivery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: Ataturk University (other)
• Locations: 1 site (Erzurum)
• Trial ID: NCT07494955 on ClinicalTrials.gov

What this trial studies

This is a prospective, randomized, parallel-group trial comparing a standardized 5-minute mindfulness-based slow-breathing exercise to standard preoperative care in women scheduled for elective cesarean under spinal anesthesia. Participants are randomized 1:1 and the breathing intervention targets approximately six breaths per minute with diaphragmatic technique delivered immediately before spinal placement. The study will monitor hemodynamic responses intraoperatively, including incidence and severity of spinal anesthesia–induced hypotension, vasopressor use, and perioperative anxiety measures. Data will be used to determine whether a brief autonomic-modulating intervention can alter physiologic responses to neuraxial blockade in this population.

Who should consider this trial

Good fit: Ideal candidates are pregnant women aged 18–45 years with a singleton pregnancy at ≥37 weeks, ASA physical status II, BMI ≤35 kg/m2, able to follow verbal instructions, and scheduled for elective cesarean under spinal anesthesia who can provide informed consent.

Not a fit: Patients with emergency cesarean sections, hypertensive disorders of pregnancy, multiple gestation, significant cardiac or pulmonary disease, chronic autonomic dysfunction, or contraindications to spinal anesthesia are unlikely to be eligible or to benefit from this intervention.

Why it matters

Potential benefit: If successful, this low-cost, nonpharmacologic intervention could reduce the frequency or severity of spinal anesthesia–related hypotension and lower vasopressor requirements during elective cesarean deliveries.

How similar studies have performed: Small prior studies of paced breathing and brief mindfulness have shown reductions in anxiety and favorable autonomic changes, but evidence specifically demonstrating prevention of spinal anesthesia–induced hypotension during cesarean is limited.

Eligibility criteria

Inclusion Criteria:

Pregnant women aged 18-45 years Singleton pregnancy Gestational age 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) 35 kg/m2 or less Ability to comprehend verbal instructions and perform the breathing exercise Provision of written informed consent

Exclusion Criteria:

Emergency cesarean section Hypertensive disorders of pregnancy (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 disease (arrhythmia, valvular disease, cardiomyopathy) Diabetes mellitus with autonomic neuropathy Thyroid dysfunction Chronic pulmonary disease potentially affecting respiratory 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 precluding adequate performance of the breathing exercise Prior regular practice of meditation, yoga, or mindfulness-based training

Where this trial is running

Erzurum

• Atatürk University Research Hospital — Erzurum, Turkey (Türkiye) (RECRUITING)

Study contacts

• Study coordinator: esra dilara ayber, MD

Conditions: Hypotension, Cesarean Section, Hemodynamic Instability, Anxiety, Anticipatory, Spinal anesthesia, Cesarean section, Mindfulness, Breathing exercise