RecruitingNot ApplicableNCT07494955

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

"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"


Sponsor

Aysenur Dostbil

Enrollment

150 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called Mindfulness-Based Breathing Exercise for people with anxiety, anticipatory, cesarean section, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALMindfulness-Based Breathing Exercise

"A standardized 5-minute mindfulness-based breathing exercise at approximately 6 breaths per minute (4-second nasal inhalation, 6-second oral exhalation), guided by a trained anesthesiologist or nurse using a standardized verbal script. During each exhalation, participants silently repeat: 'My body is relaxing as I exhale.'"


Locations(1)

Atatürk University Research Hospital

Erzurum, Turkey (Türkiye)

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NCT07494955


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