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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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Turkey
Atatürk University Research Hospital
RECRUITING
Erzurum
Contact Information
Primary
esra dilara ayber, MD
esraayber@hotmail.com
+905077794216
Backup
aysenur dostbil, PROF. DR.
adostbil@hotmail.com
+905333676696
Time Frame
Start Date: 2026-03-01
Estimated Completion Date: 2028-03-01
Participants
Target number of participants: 150
Treatments
Experimental: Arm 1 Title: Mindfulness-Based Breathing Exercise Group
Participants allocated to this arm will receive a standardized 5-minute mindfulness-based breathing exercise immediately prior to spinal anesthesia induction. The intervention will be administered by a trained anesthesiologist or nurse using a standardized script. The breathing protocol consists of slow diaphragmatic breathing at approximately 6 breaths per minute, with a 4-second nasal inhalation followed by a 6-second oral exhalation. During each exhalation, participants will be instructed to silently repeat the phrase My body is relaxing as I exhale, incorporating a mindfulness-based cognitive component. The exercise will be performed in a comfortable position in the operating room following establishment of standard monitoring (ECG, non-invasive blood pressure, SpO₂).
No_intervention: Arm 2 Title: Control Group
Participants allocated to this arm will receive standard preoperative care without any breathing exercise, relaxation technique, or mindfulness-based intervention. Following establishment of standard monitoring (ECG, non-invasive blood pressure, SpO₂) in the operating room, participants will wait for the equivalent duration before spinal anesthesia induction, consistent with routine clinical practice at the study center.
Related Therapeutic Areas
Sponsors
Leads: Aysenur Dostbil

This content was sourced from clinicaltrials.gov