[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630998":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":37,"locations":47,"responsibleParty":72,"collaborators":18,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":18,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":99,"overallStatus":50,"whyStopped":18,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Ataturk University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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).",[13],"Behavioral: Mindfulness-Based Breathing Exercise",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"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.'\"",[9],[26,27,28],"Slow Breathing Exercise","Controlled Deep Breathing","Mindfulness-Based Relaxation Technique",[30,34],{"name":31,"affiliation":32,"role":33},"kamber kaşali","Atatürk University Faculty of Medicine, Department of Biostatistics, Erzurum, Turkey","STUDY_DIRECTOR",{"name":35,"affiliation":36,"role":33},"gamze nur cimilli şenocak, MD","Atatürk University Faculty of Medicine, Department of Obstetrics and Gynecology, Erzurum, Turkey",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":18,"email":42},"esra dilara ayber, MD","CONTACT","+905077794216","esraayber@hotmail.com",{"name":44,"role":40,"phone":45,"phoneExt":18,"email":46},"aysenur dostbil, PROF. DR.","+905333676696","adostbil@hotmail.com",[48],{"facility":49,"status":50,"city":51,"state":18,"zip":52,"country":53,"countryCode":18,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Atatürk University Research Hospital","RECRUITING","Erzurum","25240","Turkey (Türkiye)",{"type":55,"coordinates":56},"Point",[57,58],41.27694,39.90861,{"lat":58,"lon":57},[61,63,66,68,70],{"name":62,"role":40,"phone":41,"phoneExt":18,"email":42},"ESRA DILARA AYBER, MD",{"name":64,"role":65,"phone":18,"phoneExt":18,"email":18},"aysenur dostbil, MD","PRINCIPAL_INVESTIGATOR",{"name":39,"role":67,"phone":18,"phoneExt":18,"email":18},"SUB_INVESTIGATOR",{"name":69,"role":67,"phone":18,"phoneExt":18,"email":18},"gamze nur cimilli senocak, MD",{"name":71,"role":67,"phone":18,"phoneExt":18,"email":18},"kamber kaseli",{"type":73,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Aysenur Dostbil","Professor of Anesthesiology and Reanimation","100630998","effect-of-pre-spinal-mindfulness-based-breathing-exercise-on-hemodynamic-response-in-elective-cesarean-section-100630998",false,"NCT07494955","\"Effect of Pre-Spinal Mindfulness-Based Breathing Exercise on Hemodynamic Response in Elective Cesarean Section\"","\"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\"","BREATHE-CS","Inclusion Criteria:\n\nPregnant 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\u002Fm2 or less Ability to comprehend verbal instructions and perform the breathing exercise Provision of written informed consent\n\nExclusion Criteria:\n\nEmergency 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\u002Fm2 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","FEMALE","18 Years","45 Years",{"count":88,"type":89},150,"ESTIMATED","INTERVENTIONAL",[92],"NA","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.\n\nThis 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.\n\nThe 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.\n\nThe 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.\n\nThe 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.",[95,96,97,98],"Hypotension","Cesarean Section","Hemodynamic Instability","Anxiety, Anticipatory",[100,95,101,102,103,104,105,106,107,108,109,110,111,112,113],"Spinal anesthesia","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","2026-03-27",{"date":116,"type":117},"2026-04-01","ACTUAL",{"date":119,"type":117},"2026-03-01",{"date":121,"type":89},"2028-03-01",{"name":74,"class":6},1]