- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06795321
Personality and Anesthesia Preferences in Cesarean Delivery
Patients' Anesthesia Preferences for Cesarean Delivery: Exploring the Role of Personality Beliefs in Spinal vs. General Anesthesia
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Samsun, Turkey, 55139
- Ondokuz Mayis University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Group S
spinal anesthesia
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Patients who preferred spinal anesthesia were included in this group.
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Group G
general anesthesia
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Patients who preferred spinal anesthesia were included in this group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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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.
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The time when the patients were in the preoperative waiting room before surgery.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Patient satisfaction
Time Frame: postoperative day 1
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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).
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postoperative day 1
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Sociodemographic datas
Time Frame: preoperative 30 minutes ago
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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.
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preoperative 30 minutes ago
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Spielberger State Anxiety Inventory (STAI I-II)
Time Frame: The time when the patients were in the preoperative waiting room before surgery.
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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.
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The time when the patients were in the preoperative waiting room before surgery.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PAPCD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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