"Effect of Pre-Spinal Mindfulness-Based Breathing Exercise on Hemodynamic Response in Elective Cesarean Section"
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorAysenur Dostbil
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
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.'"
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Arm 1 Title: Mindfulness-Based Breathing Exercise GroupExperimental treatment 1 intervention
Group B: Arm 2 Title: Control GroupNo intervention 0 interventions
Trial outcomes
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.
Time frame
Up to 10 minutes following spinal anesthesia induction"Secondary outcomes
1
Change in Preoperative State Anxiety Score (ΔSTAI-S5)
Change in state anxiety level assessed using the validated Turkish short form of the Spielberger State-Trait Anxiety Inventory (STAI-S5), a 5-item scale scored on a 4-point Likert scale (total score range: 5-20; higher scores indicate greater anxiety). The change score will be calculated as the difference between STAI-S5 scores measured immediately before (T0) and immediately after (T1) the 5-minute breathing exercise.
Time frame
"Baseline and up to 5 minutes prior to spinal anesthesia induction"2
Incidence of Early Spinal Hypotension
Proportion of participants developing hypotension, defined as a decrease in systolic arterial pressure exceeding 20% from baseline, within the first 5 minutes and within the first 10 minutes following spinal anesthesia induction. Reported as the ratio of patients experiencing hypotension to the total number of patients per group.
Time frame
"Up to 10 minutes following spinal anesthesia induction"3
Maximum Heart Rate Decrease (ΔHR_max) Following Spinal Anesthesia
: Maximum decrease in heart rate within the first 10 minutes following spinal anesthesia induction, calculated as the difference between the heart rate measured immediately prior to spinal anesthesia (T1, reference value) and the lowest heart rate recorded during the first 10 minutes post-spinal (HR\_min). Formula: ΔHR\_max = HR\_T1 - HR\_min (beats per minute).
Time frame
"Up to 10 minutes following spinal anesthesia induction"4
Time to First Hypotensive Episode
Time elapsed (in minutes) from spinal anesthesia induction to the first recorded hypotensive episode, defined as a decrease in systolic arterial pressure exceeding 20% from baseline value (T1).
Time frame
"During surgery, up to approximately 60 minutes following spinal anesthesia induction"Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Aysenur Dostbil
Lead sponsor
Ataturk University
Sponsor institution
Source ClinicalTrials.gov