HypotensionBREATHE-CSNCT07494955
"Effect of Pre-Spinal Mindfulness-Based Breathing Exercise on Hemodynamic Response in Elective Cesarean Section"
A study testing Mindfulness-Based Breathing Exercise in people with Hypotension and Cesarean Section, run by Aysenur Dostbil at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Hypotension, Cesarean Section, Hemodynamic Instability
- What is being tested?
- Mindfulness-Based Breathing Exercise
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Atatürk University Research Hospital
Erzurum, 25240
ESRA DILARA AYBER, MD, +905077794216, esraayber@hotmail.com
aysenur dostbil, MD
About this study
Official title: "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"
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.
Read more
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.
Read the detailed description
Background and Rationale Spinal anesthesia-induced hypotension is the most common hemodynamic complication in obstetric anesthesia, with reported incidence rates ranging from 50% to 80% in parturients undergoing elective cesarean section. The underlying pathophysiology involves sympathetic blockade-mediated arteriolar and venous vasodilation, resulting in decreased systemic vascular resistance and reduced venous return, further compounded by aortocaval compression exerted by the gravid uterus.
Current prophylactic strategies including left uterine displacement, fluid co-loading, and vasopressor infusion remain the standard of care. However, these pharmacological approaches may be associated with tachycardia, hypertension, and inter-individual response variability, underscoring the need for complementary non-pharmacological interventions.
Preoperative anxiety exerts measurable effects on autonomic nervous system balance, potentially amplifying sympathetic tone and increasing hemodynamic instability following neuraxial blockade. Slow, controlled breathing exercises have been shown to enhance baroreflex sensitivity and augment parasympathetic vagal activity, suggesting that a brief mindfulness-based breathing intervention may attenuate sympathetic hyperactivity through an "autonomic preconditioning" mechanism.
Randomization and Allocation Concealment Participants will be randomized in a 1:1 ratio using a computer-generated random number sequence. Allocation concealment will be ensured through sequentially numbered, opaque, sealed envelopes (SNOSE), opened only after the patient has been transferred to the operating room and immediately before spinal anesthesia induction.
Intervention Protocol Participants in the intervention arm will receive a 5-minute guided mindfulness-based breathing exercise prior to spinal anesthesia, consisting of slow diaphragmatic breathing at approximately 6 breaths per minute (4-second nasal inhalation, 6-second oral exhalation). During each exhalation, participants silently repeat: "My body is relaxing as I exhale."
Anesthesia Management All participants will receive spinal anesthesia in the sitting position with intrathecal administration of 11.2 mg hyperbaric bupivacaine + 15 mcg fentanyl + 150 mcg morphine. Hypotension will be defined as a decrease in systolic arterial pressure (SAP) exceeding 20% from baseline and treated with norepinephrine or ephedrine. Bradycardia will be defined as heart rate ≤50 bpm and treated with intravenous atropine (1 mg).
Statistical Analysis All analyses will be performed using IBM SPSS Statistics (Statistical Package for the Social Sciences) version 20. Normality will be assessed using Shapiro-Wilk and Kolmogorov-Smirnov tests. Between-group comparisons will be performed using independent samples t-test or Mann-Whitney U test as appropriate. Categorical variables will be compared using chi-square test. Statistical significance will be set at p<0.05.
Sample Size Sample size was calculated using G*Power 3.1.9.7 software. A clinically meaningful difference of 4.5 mmHg in maximum SAP decrease (effect size = 0.48) was determined to require 70 participants per group at 80% power and 95% confidence level. Accounting for potential dropout, 150 participants (75 per group) will be enrolled.
- Being tested
- Mindfulness-Based Breathing Exercise
- 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
- Medical subject headings
- Hypotension, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Breathing ExerciseBehavioural
Also called Slow Breathing Exercise, Controlled Deep Breathing, Mindfulness-Based Relaxation Technique
"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.'"
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 10 minutes following spinal anesthesia induction"
Secondary outcomes (7)
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.
Measured: "Baseline and up to 5 minutes prior to spinal anesthesia induction"
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.
Measured: "Up to 10 minutes following spinal anesthesia induction"
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).
Measured: "Up to 10 minutes following spinal anesthesia induction"
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).
Measured: "During surgery, up to approximately 60 minutes following spinal anesthesia induction"
Proportion of Participants Requiring Vasopressor Therapy
Proportion of participants in each group requiring administration of norepinephrine or ephedrine for the treatment of spinal anesthesia-induced hypotension within the first 10 minutes following spinal induction. Reported as percentage of patients per group.
Measured: "Up to 10 minutes following spinal anesthesia induction"
Total Vasopressor Dose Administered
Total cumulative dose (in micrograms for norepinephrine; in milligrams for ephedrine) of vasopressor agents administered within the first 10 minutes following spinal anesthesia induction for the treatment of hypotension.
Measured: "Up to 10 minutes following spinal anesthesia induction"
Lowest Systolic Arterial Pressure (SAP_min) Following Spinal Anesthesia
The lowest systolic arterial pressure value (mmHg) recorded within the first 10 minutes following spinal anesthesia induction, measured by non-invasive blood pressure monitoring at 1-minute intervals.
Measured: "Up to 10 minutes following spinal anesthesia induction"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Mar 2026
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aysenur Dostbil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aysenur Dostbil, Ataturk University
- Investigators
- kamber kaşali, Study director, Atatürk University Faculty of Medicine, Department of Biostatistics, Erzurum, Turkeygamze nur cimilli şenocak, MD, Study director, Atatürk University Faculty of Medicine, Department of Obstetrics and Gynecology, Erzurum, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07494955
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/127
- Acronym
- BREATHE-CS
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: "Individual participant data will not be shared, as this is an academic thesis study conducted at a single center. Patient confidentiality will be maintained in accordance with applicable data protection regulations. Anonymized aggregate results will be reported in the final publication."
Publications
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.
PubMed 29110312Teixeira 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.
PubMed 20626361Russo 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.
PubMed 29209423Shaffer 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.
PubMed 29034226
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "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"
- ClinicalTrials.gov ID
- NCT07494955
- Acronym / sponsor ID
- BREATHE-CS / B.30.2.ATA.0.01.00/127
- Keywords
- Spinal anesthesia, Hypotension, Cesarean section, Mindfulness, Breathing exercise, Hemodynamic response, Preoperative anxiety, Autonomic nervous system
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Aysenur DostbilUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background and Rationale Spinal anesthesia-induced hypotension is the most common hemodynamic complication in obstetric anesthesia, with reported incidence rates ranging from 50% to 80% in parturients undergoing elective cesarean section. The underlying pathophysiology involves sympathetic blockade-mediated arteriolar and venous vasodilation, resulting in decreased systemic vascular resistance and reduced venous return, further compounded by aortocaval compression exerted by the gravid uterus.
Current prophylactic strategies including left uterine displacement, fluid co-loading, and vasopressor infusion remain the standard of care. However, these pharmacological approaches may be associated with tachycardia, hypertension, and inter-individual response variability, underscoring the need for complementary non-pharmacological interventions.
Preoperative anxiety exerts measurable effects on autonomic nervous system balance, potentially amplifying sympathetic tone and increasing hemodynamic instability following neuraxial blockade. Slow, controlled breathing exercises have been shown to enhance baroreflex sensitivity and augment parasympathetic vagal activity, suggesting that a brief mindfulness-based breathing intervention may attenuate sympathetic hyperactivity through an "autonomic preconditioning" mechanism.
Randomization and Allocation Concealment Participants will be randomized in a 1:1 ratio using a computer-generated random number sequence. Allocation concealment will be ensured through sequentially numbered, opaque, sealed envelopes (SNOSE), opened only after the patient has been transferred to the operating room and immediately before spinal anesthesia induction.
Intervention Protocol Participants in the intervention arm will receive a 5-minute guided mindfulness-based breathing exercise prior to spinal anesthesia, consisting of slow diaphragmatic breathing at approximately 6 breaths per minute (4-second nasal inhalation, 6-second oral exhalation). During each exhalation, participants silently repeat: "My body is relaxing as I exhale."
Anesthesia Management All participants will receive spinal anesthesia in the sitting position with intrathecal administration of 11.2 mg hyperbaric bupivacaine + 15 mcg fentanyl + 150 mcg morphine. Hypotension will be defined as a decrease in systolic arterial pressure (SAP) exceeding 20% from baseline and treated with norepinephrine or ephedrine. Bradycardia will be defined as heart rate ≤50 bpm and treated with intravenous atropine (1 mg).
Statistical Analysis All analyses will be performed using IBM SPSS Statistics (Statistical Package for the Social Sciences) version 20. Normality will be assessed using Shapiro-Wilk and Kolmogorov-Smirnov tests. Between-group comparisons will be performed using independent samples t-test or Mann-Whitney U test as appropriate. Categorical variables will be compared using chi-square test. Statistical significance will be set at p<0.05.
Sample Size Sample size was calculated using G*Power 3.1.9.7 software. A clinically meaningful difference of 4.5 mmHg in maximum SAP decrease (effect size = 0.48) was determined to require 70 participants per group at 80% power and 95% confidence level. Accounting for potential dropout, 150 participants (75 per group) will be enrolled.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Title: Mindfulness-Based Breathing Exercise Group | Experimental | Behavioral: Mindfulness-Based Breathing ExerciseParticipants 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). |
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Breathing ExerciseAlso: Slow Breathing Exercise, Controlled Deep Breathing, Mindfulness-Based Relaxation Technique"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.'" | Behavioural | Arm 1 Title: Mindfulness-Based Breathing Exercise Group |
Primary outcome
Maximum Decrease in Systolic Arterial Pressure (ΔSAP_max) Following Spinal Anesthesia
Time frame: Up to 10 minutes following spinal anesthesia induction"
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.
7 secondary outcomes
Change in Preoperative State Anxiety Score (ΔSTAI-S5)
Time frame: "Baseline and up to 5 minutes prior to spinal anesthesia induction"
Incidence of Early Spinal Hypotension
Time frame: "Up to 10 minutes following spinal anesthesia induction"
Maximum Heart Rate Decrease (ΔHR_max) Following Spinal Anesthesia
Time frame: "Up to 10 minutes following spinal anesthesia induction"
Time to First Hypotensive Episode
Time frame: "During surgery, up to approximately 60 minutes following spinal anesthesia induction"
Proportion of Participants Requiring Vasopressor Therapy
Time frame: "Up to 10 minutes following spinal anesthesia induction"
Total Vasopressor Dose Administered
Time frame: "Up to 10 minutes following spinal anesthesia induction"
Lowest Systolic Arterial Pressure (SAP_min) Following Spinal Anesthesia
Time frame: "Up to 10 minutes following spinal anesthesia induction"
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Background: PubMed 29110312Walker 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.
- Background: PubMed 20626361Teixeira 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.
- Background: PubMed 29209423Russo 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.
- Background: PubMed 29034226Shaffer 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.
- Individual participant dataSharing planned: No. "Individual participant data will not be shared, as this is an academic thesis study conducted at a single center. Patient confidentiality will be maintained in accordance with applicable data protection regulations. Anonymized aggregate results will be reported in the final publication."
Related trials for Hypotension
Recruiting
Individualised Blood Pressure Targets Versus Standard Care Among Critically Ill Patients With Shock
Critical Illness, Shock
Not yet recruiting
ED90 of Norepinephrine and Phenylephrine Infusion in Patients of Advanced Maternal Age
Adverse Event, Hypotension (MeSH: D007022)
Active, not recruitingObservational study
Effects of Transitional Circulation in ELBW Infants
Neonatal Prematurity, Hypotension
Enrolling by invitationPhase 4
Synthetic Angiotensin II/Giapreza in Pediatric Patients With Refractory Hypotension
Vasodilatory Shock
Active, not recruitingPhase 2
A Study in Subjects With Neurogenic Orthostatic Hypotension
Neurogenic Orthostatic Hypotension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
kamber kaşali study director
Atatürk University Faculty of Medicine, Department of Biostatistics, Erzurum, Turkey
gamze nur cimilli şenocak, MD study director
Atatürk University Faculty of Medicine, Department of Obstetrics and Gynecology, Erzurum, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Breathing Exercise in people with Hypotension and Cesarean Section, run by Aysenur Dostbil at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact esra dilara ayber, MD (+905077794216, esraayber@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Decrease in Systolic Arterial Pressure (ΔSAP_max) Following Spinal Anesthesia (time frame: Up to 10 minutes following spinal anesthesia induction"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07494955, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.