Cesarean DeliveryNCT06795321
Personality and Anesthesia Preferences in Cesarean Delivery
An observational study of Cesarean Delivery and Personality Beliefs, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
Cesarean deliveries (CD) under general anesthesia are still common despite higher risks. Clinical guidelines recommend neuraxial anesthesia, but many patients refuse it due to fear and anxiety. This study aims to compare the personality traits of mothers who chose general versus spinal anesthesia for CD. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Delivery, Personality Beliefs
- What is being tested?
- Spinal anesthesia and General anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 Nov 2024
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients aged 18-45 years, classified as ASA II or III, admitted to the Gynecology and Obstetrics Clinic of Ondokuz Mayıs University Hospital and planned for elective cesarean delivery (CD) were included. The anesthesia method (general or spinal) was chosen at the patient's discretion.
Who may be able to join
- Patients aged between 18 and 45 years,
- American Society of Anesthesiologists (ASA) classification of II-III,
- Who were planned to undergo elective cesarean delivery (CD)
Who cannot join
- Patients who did not agree to participate in the study
- Patients requiring emergency cesarean delivery (CD)
- Patients with an absolute contraindication to general or regional anesthesia
- Patients lacking the educational or mental capacity to complete the evaluation scales
- Patients who were not informed about the study during the preoperative visit or did not provide written consent to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patients' Anesthesia Preferences for Cesarean Delivery: Exploring the Role of Personality Beliefs in Spinal vs. General Anesthesia
Cesarean deliveries (CD) under general anesthesia are still common despite higher risks. Clinical guidelines recommend neuraxial anesthesia, but many patients refuse it due to fear and anxiety. This study aims to compare the personality traits of mothers who chose general versus spinal anesthesia for CD.
Read the detailed description
Cesarean deliveries (CD) under general anesthesia continue to be common in many countries, though the practice varies in frequency. In the United States, about 5.8% of CDs are performed under general anesthesia. In Europe, the rate is higher in some countries, with 10% in Germany, 30% in Spain, and 34% in the Czech Republic. The exact rate in the study's country is not known but is assumed to be high. Clinical guidelines suggest that neuraxial anesthesia (spinal or epidural) should be the preferred choice for CD unless there are specific contraindications. This recommendation stems from the increased risks of general anesthesia, which include airway complications, aspiration risks, significant blood loss, and the potential for intraoperative awareness.
General anesthesia may still be a suitable option when spinal anesthesia is contraindicated or in cases with severe complications such as fetal bradycardia, uterine rupture, heavy bleeding, or placental abruption. Despite these risks, many patients still choose or are administered general anesthesia, often rejecting neuraxial anesthesia. The use of general anesthesia for CD carries higher risks of anesthesia-related complications, surgical site infections, and venous thromboembolism. This highlights the need to minimize the unnecessary use of general anesthesia by better understanding the factors that influence patients' anesthesia preferences.
One of the most common reasons patients refuse regional anesthesia (spinal or epidural) is the fear of spinal injury, concerns about the pain from the needle insertion, or anxiety about witnessing the surgical procedure. On the other hand, those who opt for regional anesthesia often cite the fear of not waking up from general anesthesia and the desire to remain conscious during childbirth. Research also suggests that anxiety levels are linked to the choice of anesthesia, though previous studies have yielded conflicting results.
Study Hypothesis and Aim: The study hypothesizes that patients' anesthesia preferences during CD might be influenced by their personality traits. While no prior studies have examined the relationship between personality traits and anesthesia preferences specifically in CD patients, some studies have explored the impact of personality on maternal delivery preferences (whether a woman chooses CD or vaginal delivery). The primary aim of this study is to compare the personality belief scores of expecting mothers who undergo CD with either general or spinal anesthesia, according to their preferred anesthesia type.
- Conditions
- Cesarean Delivery, Personality Beliefs
- Being tested
- Spinal anesthesia, General anesthesia
- Keywords
- Cesarean delivery, Spielberger State Anxiety Inventory (STAI II), Personality Belief Questionnaire Short Form (PBQ-SF)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal anesthesiaProcedure or surgery
Patients who preferred spinal anesthesia were included in this group.
General anesthesiaProcedure or surgery
Patients who preferred spinal anesthesia were included in this group
| Study group | Role | What they receive |
|---|---|---|
| Group S | spinal anesthesia Receives: Procedure: Spinal anesthesia | |
| Group G | general anesthesia Receives: Procedure: General anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personality belief scores of patients who preferred general or spinal anesthesia
The personality belief was assessed using The Personality Belief Questionnaire Short Form (PBQ-SF). The Personality Belief Questionnaire Short Form (PBQ-SF) is a 65-item self-reported questionnaire designed to assess an individual's personality. The PBQ-SF was created by selecting the seven highest-scoring items for each personality trait from the original PBQ.12 The form contained statements related to ten different personality disorders/features (avoidant, dependent, passive-aggressive, obsessive-compulsive, antisocial, narcissistic, histrionic, schizoid, paranoid, and borderline). The patients were asked to rate the extent to which they agreed with these statements on a 0-4 scale (0 = not at all, 1 = slightly agree, 2 = moderately agree, 3 = very much agree, and 4 = totally agree). Personality traits were examined based on the scores generated by the responses. The PBQ-SF has been translated into Turkish and its validity.
Measured: The time when the patients were in the preoperative waiting room before surgery.
Secondary outcomes (3)
Patient satisfaction
The patient were asked to evaluate their satisfaction with their anesthesia experience using a 4-point Likert scale (1 = poor, 2 = average, 3 = good, and 4 = very good).
Measured: postoperative day 1
Sociodemographic datas
patients' name, surname, age, education level, employment status, income level, previous pregnancy and anesthesia experiences, smoking habits, history of psychiatric illness, medication use, and factors influencing their anesthesia preference.
Measured: preoperative 30 minutes ago
Spielberger State Anxiety Inventory (STAI I-II)
STAI is a 40-item self-report questionnaire that measures both state anxiety (how a person feels at the moment) and trait anxiety (how a person generally feels). It consists of two 20-item subscales, each scored on a 4-point scale, with scores ranging from 20 to 80. State anxiety is measured from "not at all" to "very much so," and trait anxiety from "almost never" to "almost always." The Turkish version was adapted in 1985, with higher scores indicating greater anxiety.
Measured: The time when the patients were in the preoperative waiting room before surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start1 Jan 2024
- Primary completion1 Sep 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cesarean DeliveryStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Turunc, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795321
- Sponsor's protocol ID
- PAPCD
- Status last verified
- Jan 2025
- First submitted
- 18 Jan 2025
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Turunc E, Bilgin S, Akdeniz S, Komurcu O, Tomak L, Ustun YB, Koksal E, Dost B. Patients' anesthesia preferences for Cesarean delivery: exploring the role of personality beliefs in spinal vs. General anesthesia. BMC Anesthesiol. 2025 Jul 1;25(1):313. doi: 10.1186/s12871-025-03185-w.
PubMed 40597644
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients' Anesthesia Preferences for Cesarean Delivery: Exploring the Role of Personality Beliefs in Spinal vs. General Anesthesia
- ClinicalTrials.gov ID
- NCT06795321
- Acronym / sponsor ID
- PAPCD
- Conditions
- Cesarean Delivery, Personality Beliefs
- Keywords
- Cesarean delivery, Spielberger State Anxiety Inventory (STAI II), Personality Belief Questionnaire Short Form (PBQ-SF)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 28 Jan 2025 (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.
Cesarean deliveries (CD) under general anesthesia are still common despite higher risks. Clinical guidelines recommend neuraxial anesthesia, but many patients refuse it due to fear and anxiety. This study aims to compare the personality traits of mothers who chose general versus spinal anesthesia for CD.
Detailed description
Cesarean deliveries (CD) under general anesthesia continue to be common in many countries, though the practice varies in frequency. In the United States, about 5.8% of CDs are performed under general anesthesia. In Europe, the rate is higher in some countries, with 10% in Germany, 30% in Spain, and 34% in the Czech Republic. The exact rate in the study's country is not known but is assumed to be high. Clinical guidelines suggest that neuraxial anesthesia (spinal or epidural) should be the preferred choice for CD unless there are specific contraindications. This recommendation stems from the increased risks of general anesthesia, which include airway complications, aspiration risks, significant blood loss, and the potential for intraoperative awareness.
General anesthesia may still be a suitable option when spinal anesthesia is contraindicated or in cases with severe complications such as fetal bradycardia, uterine rupture, heavy bleeding, or placental abruption. Despite these risks, many patients still choose or are administered general anesthesia, often rejecting neuraxial anesthesia. The use of general anesthesia for CD carries higher risks of anesthesia-related complications, surgical site infections, and venous thromboembolism. This highlights the need to minimize the unnecessary use of general anesthesia by better understanding the factors that influence patients' anesthesia preferences.
One of the most common reasons patients refuse regional anesthesia (spinal or epidural) is the fear of spinal injury, concerns about the pain from the needle insertion, or anxiety about witnessing the surgical procedure. On the other hand, those who opt for regional anesthesia often cite the fear of not waking up from general anesthesia and the desire to remain conscious during childbirth. Research also suggests that anxiety levels are linked to the choice of anesthesia, though previous studies have yielded conflicting results.
Study Hypothesis and Aim: The study hypothesizes that patients' anesthesia preferences during CD might be influenced by their personality traits. While no prior studies have examined the relationship between personality traits and anesthesia preferences specifically in CD patients, some studies have explored the impact of personality on maternal delivery preferences (whether a woman chooses CD or vaginal delivery). The primary aim of this study is to compare the personality belief scores of expecting mothers who undergo CD with either general or spinal anesthesia, according to their preferred anesthesia type.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group S | – | Procedure: Spinal anesthesiaspinal anesthesia |
| Group G | – | Procedure: General anesthesiageneral anesthesia |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients aged 18-45 years, classified as ASA II or III, admitted to the Gynecology and Obstetrics Clinic of Ondokuz Mayıs University Hospital and planned for elective cesarean delivery (CD) were included. The anesthesia method (general or spinal) was chosen at the patient's discretion.
Key inclusion criteria (3 listed)
- Patients aged between 18 and 45 years,
- American Society of Anesthesiologists (ASA) classification of II-III,
- Who were planned to undergo elective cesarean delivery (CD)
Key exclusion criteria (5 listed)
- Patients who did not agree to participate in the study
- Patients requiring emergency cesarean delivery (CD)
- Patients with an absolute contraindication to general or regional anesthesia
- Patients lacking the educational or mental capacity to complete the evaluation scales
- Patients who were not informed about the study during the preoperative visit or did not provide written consent to participate
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 |
|---|---|---|
| Spinal anesthesiaPatients who preferred spinal anesthesia were included in this group. | Procedure or surgery | Group S |
| General anesthesiaPatients who preferred spinal anesthesia were included in this group | Procedure or surgery | Group G |
Primary outcome
Personality belief scores of patients who preferred general or spinal anesthesia
Time frame: The time when the patients were in the preoperative waiting room before surgery.
The personality belief was assessed using The Personality Belief Questionnaire Short Form (PBQ-SF). The Personality Belief Questionnaire Short Form (PBQ-SF) is a 65-item self-reported questionnaire designed to assess an individual's personality. The PBQ-SF was created by selecting the seven highest-scoring items for each personality trait from the original PBQ.12 The form contained statements related to ten different personality disorders/features (avoidant, dependent, passive-aggressive, obsessive-compulsive, antisocial, narcissistic, histrionic, schizoid, paranoid, and borderline). The patients were asked to rate the extent to which they agreed with these statements on a 0-4 scale (0 = not at all, 1 = slightly agree, 2 = moderately agree, 3 = very much agree, and 4 = totally agree). Personality traits were examined based on the scores generated by the responses. The PBQ-SF has been translated into Turkish and its validity.
3 secondary outcomes
Patient satisfaction
Time frame: postoperative day 1
Sociodemographic datas
Time frame: preoperative 30 minutes ago
Spielberger State Anxiety Inventory (STAI I-II)
Time frame: The time when the patients were in the preoperative waiting room before surgery.
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 28 Jan 2025.
- Derived from this study: PubMed 40597644Turunc E, Bilgin S, Akdeniz S, Komurcu O, Tomak L, Ustun YB, Koksal E, Dost B. Patients' anesthesia preferences for Cesarean delivery: exploring the role of personality beliefs in spinal vs. General anesthesia. BMC Anesthesiol. 2025 Jul 1;25(1):313. doi: 10.1186/s12871-025-03185-w.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cesarean Delivery and Personality Beliefs, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
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 3 inclusion and 5 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 28 Jan 2025. 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 Turkey (Türkiye). 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?
Personality belief scores of patients who preferred general or spinal anesthesia (time frame: The time when the patients were in the preoperative waiting room before surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06795321, which also lists 1 linked publication.
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 28 Jan 2025.