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

NCT07494955 | Recruiting

• 1 other identifier: B.30.2.ATA.0.01.00/127
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Spinal anesthesia; Hypotension; Cesarean section; Mindfulness; Breathing exercise; Hemodynamic response; Preoperative anxiety; Autonomic nervous system; Obstetric anesthesia; Vasopressor; Systolic blood pressure; Heart rate variability; Non-pharmacological intervention; Randomized controlled trial; Baroreflex sensitivity

Outcome Measures

Primary Outcomes (1)

• Maximum Decrease in Systolic Arterial Pressure (ΔSAP_max) Following Spinal Anesthesia

  he primary outcome is the maximum decrease in systolic arterial pressure (SAP) within the first 10 minutes following spinal anesthesia induction, calculated as the difference between the SAP value measured immediately prior to spinal anesthesia (T1, reference value) and the lowest SAP value recorded during the first 10 minutes post-spinal (SAP\_min). Formula: ΔSAP\_max = SAP\_T1 - SAP\_min (mmHg). SAP will be measured non-invasively at 1-minute intervals during the first 10 minutes following spinal induction.

  Up to 10 minutes following spinal anesthesia induction"

Secondary Outcomes (7)

• Change in Preoperative State Anxiety Score (ΔSTAI-S5)

  "Baseline and up to 5 minutes prior to spinal anesthesia induction"

• Incidence of Early Spinal Hypotension

  "Up to 10 minutes following spinal anesthesia induction"

• Maximum Heart Rate Decrease (ΔHR_max) Following Spinal Anesthesia

  "Up to 10 minutes following spinal anesthesia induction"

• Time to First Hypotensive Episode

  "During surgery, up to approximately 60 minutes following spinal anesthesia induction"

• Proportion of Participants Requiring Vasopressor Therapy

  "Up to 10 minutes following spinal anesthesia induction"

Study Arms (2)

Arm 1 Title: Mindfulness-Based Breathing Exercise Group

EXPERIMENTAL

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).

Behavioral: Mindfulness-Based Breathing Exercise

Arm 2 Title: Control Group

NO INTERVENTION

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.

Interventions

Mindfulness-Based Breathing Exercise BEHAVIORAL

"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.'"

Also known as: Slow Breathing Exercise, Controlled Deep Breathing, Mindfulness-Based Relaxation Technique

Arm 1 Title: Mindfulness-Based Breathing Exercise Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aysenur Dostbil: lead

Study Sites (1)

Atatürk University Research Hospital

Erzurum, 25240, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• Walker AP, McCormack ML, Messier J, Myers-Smith IH, Wullschleger SD. Trait covariance: the functional warp of plant diversity? New Phytol. 2017 Dec;216(4):976-980. doi: 10.1111/nph.14853. No abstract available.

  PMID: 29110312 BACKGROUND

• Teixeira AG, Silva AS, Lin FL, Velletri R, Bavia L, Belfort R Jr, Isaac L. Association of complement factor H Y402H polymorphism and age-related macular degeneration in Brazilian patients. Acta Ophthalmol. 2010 Aug;88(5):e165-9. doi: 10.1111/j.1755-3768.2010.01932.x. Epub 2010 Jul 6.

  PMID: 20626361 BACKGROUND

• Russo MA, Santarelli DM, O'Rourke D. The physiological effects of slow breathing in the healthy human. Breathe (Sheff). 2017 Dec;13(4):298-309. doi: 10.1183/20734735.009817.

  PMID: 29209423 BACKGROUND

• Shaffer F, Ginsberg JP. An Overview of Heart Rate Variability Metrics and Norms. Front Public Health. 2017 Sep 28;5:258. doi: 10.3389/fpubh.2017.00258. eCollection 2017.

  PMID: 29034226 BACKGROUND

MeSH Terms

Conditions

Hypotension; Anxiety Disorders

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Mental Disorders

Study Officials

• kamber kaşali

  Atatürk University Faculty of Medicine, Department of Biostatistics, Erzurum, Turkey

  STUDY DIRECTOR

• gamze nur cimilli şenocak, MD

  Atatürk University Faculty of Medicine, Department of Obstetrics and Gynecology, Erzurum, Turkey

  STUDY DIRECTOR

Central Study Contacts

esra dilara ayber, MD

CONTACT

+905077794216; esraayber@hotmail.com

aysenur dostbil, PROF. DR.

CONTACT

+905333676696; adostbil@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, blinding of participants and care providers is not feasible in this trial. However, outcome assessor blinding will be implemented to minimize measurement bias. Hemodynamic data (systolic arterial pressure, heart rate, and peripheral oxygen saturation) will be recorded prospectively by a designated investigator who is blinded to group allocation and has no involvement in the administration of the breathing exercise or the randomization process. This single-blind design ensures that primary and secondary hemodynamic outcome measurements are obtained independently of treatment assignment, thereby reducing the risk of assessment bias.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Anesthesiology and Reanimation

Model Details: This study employs a two-arm parallel-group design in which eligible participants are randomly assigned in a 1:1 ratio to either the Mindfulness-Based Breathing Exercise Group or the Control Group. Participants in the intervention arm receive a standardized 5-minute mindfulness-based breathing exercise immediately prior to spinal anesthesia induction, while participants in the control arm receive standard preoperative care without any breathing or relaxation intervention. Each participant is assigned to one group only, with no crossover between arms. Randomization is performed using a computer-generated random number sequence with allocation concealment ensured through sequentially numbered, opaque, sealed envelopes (SNOSE).

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 27, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)