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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04614220
Acronym
BSU
Enrollment
110
Registered
2020-11-03
Start date
2021-03-01
Completion date
2021-09-01
Last updated
2023-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acceptability of Health Care

Keywords

Caesarean Section, Regional anaesthesia, Consent

Brief 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.

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.

Interventions

BEHAVIORALPresence of Family member

The correlation between presence of the Family member and the consent for regional anaesthesia for Caesarean Section

Sponsors

Beni-Suef University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Acceptance rate to spinal anaethesia during CSPreoperative .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.
Anxiety score by the visual analogue score (VAS).Preoperativethe visual analog score (VAS) from 0- 10, where 10 is the maximum anxiety level
Satisfaction rating scale6 hours PostoperativeScale ( 1 - 10 ) 1is the lowest satisfaction 10 is the best satisfaction

Secondary

MeasureTime frameDescription
peripheral oxygen saturation (Spo2)Preoperativeperipheral oxygen saturation (Spo2)
AGEPreoperativeage per years
HeightPreoperativeHeight per centimeter
WEIGHTPreoperativeweight per kilograms
heart rate (beat/min)Preoperativeheart rate (beat/min)
Mean arterial blood pressure MAP (mmHg)PreoperativeMean arterial blood pressure MAP (mmHg)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026