The Correlation Between Family Member Presence and The Consent for Regional Anaesthesia for Caesarean Section

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Preoperative 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. The 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.

Official Title
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The Correlation Between Family Member Presence and The Consent for Regional Anaesthesia for Cesarean Section of Primigravida: A Prospective Observational Study

Conditions
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Acceptability of Health Care

Intervention / Treatment
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* Behavioral: Presence of Family member


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primi gravida Patients aging 20_40 years, ASA physical status I undergoing elective CS • Exclusion criteria: High 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Presence of Family member|The correlation between presence of the Family member and the consent for regional anaesthesia for Caesarean Section|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptance rate to spinal anaethesia during CS | Questionnaire : The first decision for anesthesia, either spinal or general, will be recorded. Then, 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. | Preoperative . | 
| Anxiety score by the visual analogue score (VAS). | the visual analog score (VAS) from 0- 10, where 10 is the maximum anxiety level | Preoperative | 
| Satisfaction rating scale | Scale ( 1 - 10 ) 1is the lowest satisfaction 10 is the best satisfaction | 6 hours Postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AGE | age per years | Preoperative | 
| heart rate (beat/min) | heart rate (beat/min) | Preoperative | 
| Mean arterial blood pressure MAP (mmHg) | Mean arterial blood pressure MAP (mmHg) | Preoperative | 
| peripheral oxygen saturation (Spo2) | peripheral oxygen saturation (Spo2) | Preoperative | 
| WEIGHT | weight per kilograms | Preoperative | 
| Height | Height per centimeter | Preoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caesarean Section, Regional anaesthesia, Consent