Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT04614220
Status:
COMPLETED
Last Update Posted:
2023-09-08
First Post:
2020-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Correlation Between Family Member Presence and The Consent for Regional Anaesthesia for Caesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}], 'ancestors': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-06', 'studyFirstSubmitDate': '2020-10-27', 'studyFirstSubmitQcDate': '2020-11-02', 'lastUpdatePostDateStruct': {'date': '2023-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptance rate to spinal anaethesia during CS', 'timeFrame': 'Preoperative .', 'description': 'Questionnaire : The first decision for anesthesia, either spinal or general, will be recorded.\n\nThen, patients who refuse SA and prefer general anesthesia (GA) will be consulted again as regards SA with presence of close relative for comfortable spinal procedure. Their last choice is the second decision that determines the final type of anesthesia to be implemented.'}, {'measure': 'Anxiety score by the visual analogue score (VAS).', 'timeFrame': 'Preoperative', 'description': 'the visual analog score (VAS) from 0- 10, where 10 is the maximum anxiety level'}, {'measure': 'Satisfaction rating scale', 'timeFrame': '6 hours Postoperative', 'description': 'Scale ( 1 - 10 )\n\n1is the lowest satisfaction 10 is the best satisfaction'}], 'secondaryOutcomes': [{'measure': 'AGE', 'timeFrame': 'Preoperative', 'description': 'age per years'}, {'measure': 'heart rate (beat/min)', 'timeFrame': 'Preoperative', 'description': 'heart rate (beat/min)'}, {'measure': 'Mean arterial blood pressure MAP (mmHg)', 'timeFrame': 'Preoperative', 'description': 'Mean arterial blood pressure MAP (mmHg)'}, {'measure': 'peripheral oxygen saturation (Spo2)', 'timeFrame': 'Preoperative', 'description': 'peripheral oxygen saturation (Spo2)'}, {'measure': 'WEIGHT', 'timeFrame': 'Preoperative', 'description': 'weight per kilograms'}, {'measure': 'Height', 'timeFrame': 'Preoperative', 'description': 'Height per centimeter'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Caesarean Section', 'Regional anaesthesia', 'Consent'], 'conditions': ['Acceptability of Health Care']}, 'descriptionModule': {'briefSummary': "Patient's safety and satisfaction are major concerns of anesthesiologists and obstetricians. According to evidence guidelines, and quality markers, regional anesthesia is preferred over general in obstetric surgery. Already a high level of anxiety is present in obstetric patients preoperatively.", 'detailedDescription': "Hospital anxiety is commonly encountered, and it is reported to be seen in 60%-80% of patients who undergo surgery. There are many causes of preoperative anxiety including fear of death due to anesthesia or surgical procedure and fear of preoperative or postoperative pain.\n\nPreoperative anxiety varies according to the patient's age, gender, educational status, history of previous operations, and medical status as well as the type of surgery and type of anesthesia. Patient's safety and satisfaction are major concerns of anesthesiologists and obstetricians. According to evidence guidelines, and quality markers, regional anesthesia is preferred over general in obstetric surgery. Already a high level of anxiety is present in obstetric patients preoperatively.\n\nThe anxious patients tend to prefer general anesthesia (GA) for cesarean section (CS). The patient refusal is the main contraindication for applying spinal anesthesia (SA) during CS. The anxiety can be reduced variably by non-pharmacologic and pharmacologic methods including preoperative visit, information, and music, listening to Holy Quran recitation, hypnosis, nitrous oxide, and benzodiazepines. Intravenous sedation can control the anxiety in 90% of patients subjected to spinal procedures. While the evidence supports the benefits of procedural sedation for distressed, anxious pregnant women."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '110 primi gravida Patients aging 20\\_40 years, ASA physical status I undergoing elective CS •', 'genderDescription': 'Caesarean Section', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primi gravida Patients aging 20\\_40 years, ASA physical status I undergoing elective CS •\n\nExclusion criteria:\n\nHigh risk pregnancy eg: pre eclampsia Absolute contra indiction for SA eg: severe anaemia Emergent CS. Patients with previous exposure to anaesthesia ( spinal or general ). Patients with educational level more than high school.'}, 'identificationModule': {'nctId': 'NCT04614220', 'acronym': 'BSU', 'briefTitle': 'The Correlation Between Family Member Presence and The Consent for Regional Anaesthesia for Caesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Beni-Suef University'}, 'officialTitle': 'The Correlation Between Family Member Presence and The Consent for Regional Anaesthesia for Cesarean Section of Primigravida: A Prospective Observational Study', 'orgStudyIdInfo': {'id': 'FMBSUREC/04102020/ Bahr'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Presence of Family member', 'type': 'BEHAVIORAL', 'description': 'The correlation between presence of the Family member and the consent for regional anaesthesia for Caesarean Section'}]}, 'contactsLocationsModule': {'locations': [{'zip': '62511', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of medicine.Beni-suef university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Amira F Elgamel, Lecturer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of medicine.Beni-suef university'}]}, 'ipdSharingStatementModule': {'url': 'https://www.bsu.edu.eg/home.aspx?lang=en', 'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': '3 months', 'ipdSharing': 'YES', 'description': 'The surgeon and the anesthetist will discuss the exclusion criteria, and then discuss the information about spinal and general anesthesia with the illegible patients. The first decision for anesthesia, either spinal or general, will be recorded.\n\nThen, patients who refuse SA and prefer general anesthesia (GA) will be consulted again as regards SA with presence of close relative for comfortable spinal procedure. Their last choice is the second decision that determines the final type of anesthesia to be implemented. The acceptance rate of SA with presence of close relative will be the primary outcome. A written consent will be taken. The number of crying patients and anxiety causes will be documented just before SA. The anxiety score will be assessed by the visual analog score (VAS) from 0- 10, where 10 is the maximum anxiety level .', 'accessCriteria': 'drmahmoudbahr@gmail.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beni-Suef University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer in Department of Anaesthesia , surgical ICU and pain management (Faculty of medicine)', 'investigatorFullName': 'Mahmoud Hussein Bahr', 'investigatorAffiliation': 'Beni-Suef University'}}}}