Acceptability of Health CareBSUNCT04614220
The Correlation Between Family Member Presence and The Consent for Regional Anaesthesia for Caesarean Section
An observational study of Acceptability of Health Care, run by Beni-Suef University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Acceptability of Health Care
- What is being tested?
- Presence of Family member
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2021to 1 Sep 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: 110 primi gravida Patients aging 20_40 years, ASA physical status I undergoing elective CS •
Who may be able to join
- primi gravida Patients aging 20_40 years, ASA physical status I undergoing elective CS •
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Acceptability of Health Care
- Being tested
- Presence of Family member
- Keywords
- Caesarean Section, Regional anaesthesia, Consent
- Medical subject headings
- Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Presence of Family memberBehavioural
The correlation between presence of the Family member and the consent for regional anaesthesia for Caesarean Section
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Preoperative .
Anxiety score by the visual analogue score (VAS).
the visual analog score (VAS) from 0- 10, where 10 is the maximum anxiety level
Measured: Preoperative
Satisfaction rating scale
Scale ( 1 - 10 )
1is the lowest satisfaction 10 is the best satisfaction
Measured: 6 hours Postoperative
Secondary outcomes (6)
AGE
age per years
Measured: Preoperative
heart rate (beat/min)
heart rate (beat/min)
Measured: Preoperative
Mean arterial blood pressure MAP (mmHg)
Mean arterial blood pressure MAP (mmHg)
Measured: Preoperative
peripheral oxygen saturation (Spo2)
peripheral oxygen saturation (Spo2)
Measured: Preoperative
WEIGHT
weight per kilograms
Measured: Preoperative
Height
Height per centimeter
Measured: Preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start1 Mar 2021
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acceptability of Health CareStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Hussein Bahr, Beni-Suef University
- Investigators
- Amira F Elgamel, Lecturer, Study director, Faculty of medicine.Beni-suef university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614220
- Sponsor's protocol ID
- FMBSUREC/04102020/ Bahr
- Acronym
- BSU
- Status last verified
- Sep 2023
- First submitted
- 27 Oct 2020
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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 .
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between Family Member Presence and The Consent for Regional Anaesthesia for Cesarean Section of Primigravida: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04614220
- Acronym / sponsor ID
- BSU / FMBSUREC/04102020/ Bahr
- Conditions
- Acceptability of Health Care
- Keywords
- Caesarean Section, Regional anaesthesia, Consent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 3 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 110 primi gravida Patients aging 20_40 years, ASA physical status I undergoing elective CS •
Key inclusion criteria (1 listed)
- primi gravida Patients aging 20_40 years, ASA physical status I undergoing elective CS •
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Presence of Family memberThe correlation between presence of the Family member and the consent for regional anaesthesia for Caesarean Section | Behavioural | – |
Primary outcome
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.
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
Satisfaction rating scale
Time frame: 6 hours Postoperative
Scale ( 1 - 10 ) 1is the lowest satisfaction 10 is the best satisfaction
6 secondary outcomes
AGE
Time frame: Preoperative
heart rate (beat/min)
Time frame: Preoperative
Mean arterial blood pressure MAP (mmHg)
Time frame: Preoperative
peripheral oxygen saturation (Spo2)
Time frame: Preoperative
WEIGHT
Time frame: Preoperative
Height
Time frame: Preoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Individual participant dataSharing planned: Yes. 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 .
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amira F Elgamel, Lecturer study director
Faculty of medicine.Beni-suef university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acceptability of Health Care, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptance rate to spinal anaethesia during CS (time frame: Preoperative .). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.