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Completed

NCT Number: NCT04614220

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

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.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Faculty of medicine.Beni-suef university

Cairo, 62511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Presence of Family member

Behavioral

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

Primary outcomes

  1. Acceptance rate to spinal anaethesia during CS

    Time frame: Preoperative .

    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.

  2. Anxiety score by the visual analogue score (VAS).

    Time frame: Preoperative

    the visual analog score (VAS) from 0- 10, where 10 is the maximum anxiety level

  3. Satisfaction rating scale

    Time frame: 6 hours Postoperative

    Scale ( 1 - 10 )

    1is the lowest satisfaction 10 is the best satisfaction

Secondary outcomes

  1. AGE

    Time frame: Preoperative

    age per years

  2. heart rate (beat/min)

    Time frame: Preoperative

    heart rate (beat/min)

  3. Mean arterial blood pressure MAP (mmHg)

    Time frame: Preoperative

    Mean arterial blood pressure MAP (mmHg)

  4. peripheral oxygen saturation (Spo2)

    Time frame: Preoperative

    peripheral oxygen saturation (Spo2)

  5. WEIGHT

    Time frame: Preoperative

    weight per kilograms

  6. Height

    Time frame: Preoperative

    Height per centimeter

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

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

Acronym: BSU

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 3, 2020
Registry last updated
Sep 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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