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

NCT07494955 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-04-01

No results posted yet for this study

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.

Conditions

  • Hypotension
  • Cesarean Section
  • Hemodynamic Instability
  • Anxiety, Anticipatory

Interventions

BEHAVIORAL

Mindfulness-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.'"

Sponsors & Collaborators

  • Aysenur Dostbil

    lead OTHER

Principal Investigators

  • kamber kaşali · Atatürk University Faculty of Medicine, Department of Biostatistics, Erzurum, Turkey

  • gamze nur cimilli şenocak, MD · Atatürk University Faculty of Medicine, Department of Obstetrics and Gynecology, Erzurum, Turkey

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2028-03-01
Completion
2028-03-01

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07494955 on ClinicalTrials.gov