NCT04614220

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 3, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

September 8, 2023

Status Verified

September 1, 2023

Enrollment Period

6 months

First QC Date

October 27, 2020

Last Update Submit

September 6, 2023

Conditions

Acceptability of Health Care

Keywords

Caesarean SectionRegional anaesthesiaConsent

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (6)

  • AGE

    Preoperative

  • heart rate (beat/min)

    Preoperative

  • Mean arterial blood pressure MAP (mmHg)

    Preoperative

  • peripheral oxygen saturation (Spo2)

    Preoperative

  • WEIGHT

    Preoperative

  • +1 more secondary outcomes

Interventions

Presence of Family memberBEHAVIORAL

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

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsCaesarean Section
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine.Beni-suef university

Cairo, 62511, Egypt

Location

MeSH Terms

Conditions

Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Amira F Elgamel, Lecturer

    Faculty of medicine.Beni-suef university

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in Department of Anaesthesia , surgical ICU and pain management (Faculty of medicine)

Study Record Dates

First Submitted

October 27, 2020

First Posted

November 3, 2020

Study Start

March 1, 2021

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

September 8, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

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 .

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
3 months
Access Criteria
drmahmoudbahr@gmail.com
More information

Locations

EG(1)