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

Acceptability of Health Care Clinical Trial

— BSU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04614220
• Other study ID #: FMBSUREC/04102020/ Bahr
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: September 1, 2021

Study information

• Verified date: September 2023
• Source: Beni-Suef University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acceptability of Health Care

Intervention

Behavioral:
• Presence of Family member
The correlation between presence of the Family member and the consent for regional anaesthesia for Caesarean Section

Locations

Country	Name	City	State
Egypt	Faculty of medicine.Beni-suef university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 .
Primary	Anxiety score by the visual analogue score (VAS).	the visual analog score (VAS) from 0- 10, where 10 is the maximum anxiety level	Preoperative
Primary	Satisfaction rating scale	Scale ( 1 - 10 ); 1is the lowest satisfaction 10 is the best satisfaction	6 hours Postoperative
Secondary	AGE	age per years	Preoperative
Secondary	heart rate (beat/min)	heart rate (beat/min)	Preoperative
Secondary	Mean arterial blood pressure MAP (mmHg)	Mean arterial blood pressure MAP (mmHg)	Preoperative
Secondary	peripheral oxygen saturation (Spo2)	peripheral oxygen saturation (Spo2)	Preoperative
Secondary	WEIGHT	weight per kilograms	Preoperative
Secondary	Height	Height per centimeter	Preoperative