NCT06795321

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

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

Study Start

First participant enrolled

January 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 28, 2025

Completed
Last Updated

January 28, 2025

Status Verified

January 1, 2025

Enrollment Period

8 months

First QC Date

January 18, 2025

Last Update Submit

January 25, 2025

Conditions

Cesarean DeliveryPersonality Beliefs

Keywords

Cesarean deliverySpielberger State Anxiety Inventory (STAI II)Personality Belief Questionnaire Short Form (PBQ-SF)

Outcome Measures

Primary Outcomes (1)

  • 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.

    The time when the patients were in the preoperative waiting room before surgery.

Secondary Outcomes (3)

  • Patient satisfaction

    postoperative day 1

  • Sociodemographic datas

    preoperative 30 minutes ago

  • Spielberger State Anxiety Inventory (STAI I-II)

    The time when the patients were in the preoperative waiting room before surgery.

Study Arms (2)

Group S

spinal anesthesia

Procedure: Spinal anesthesia

Group G

general anesthesia

Procedure: General anesthesia

Interventions

Spinal anesthesiaPROCEDURE

Patients who preferred spinal anesthesia were included in this group.

Group S
General anesthesiaPROCEDURE

Patients who preferred spinal anesthesia were included in this group

Group G

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWho were planned to undergo elective cesarean delivery (CD) (only female)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayis University

Samsun, 55139, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 40597644DERIVED

MeSH Terms

Interventions

Anesthesia, SpinalAnesthesia, General

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

January 18, 2025

First Posted

January 28, 2025

Study Start

January 1, 2024

Primary Completion

September 1, 2024

Study Completion

November 1, 2024

Last Updated

January 28, 2025

Record last verified: 2025-01

Locations

TU(1)