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

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

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.

Study Overview

• Status: Completed
• Conditions: Acceptability of Health Care
• Intervention / Treatment: Behavioral: Presence of Family member

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 62511
    • Faculty of medicine.Beni-suef university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

110 primi gravida Patients aging 20_40 years, ASA physical status I undergoing elective CS •

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Investigators: Study Director: Amira F Elgamel, Lecturer, Faculty of medicine.Beni-suef university

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: October 27, 2020
• First Submitted That Met QC Criteria: November 2, 2020
• First Posted (Actual): November 3, 2020

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Caesarean Section; Regional anaesthesia; Consent
• Other Study ID Numbers: FMBSUREC/04102020/ Bahr

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan 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.

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. 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 .

• IPD Sharing Time Frame: 3 months
• IPD Sharing Access Criteria: drmahmoudbahr@gmail.com
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No