Visual Education for Spinal Anesthesia Acceptance | NCT06910826

Studies
Visual Education for Spinal Anesthesia Acceptance

NCT06910826

Sponsor

Istinye University

Status

Not yet recruiting

Last Update Posted

Apr 4, 2025Actual

Enrollment

318Estimated

Phase

Not provided

Conditions

Incidence of Spinal Anesthesia Preference

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2025Estimated

Primary Completion Date

Aug 1, 2025Estimated

Completion Date

Aug 15, 2025Estimated

First Submitted Date

Mar 28, 2025

First Submission Date that Met QC Criteria

Mar 28, 2025

First Posted Date

Apr 4, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2025

Last Update Posted Date

Apr 4, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Primary outcome: To determine the incidence of spinal anesthesia preference after exposure to the visual information catalog.

Secondary outcomes: To analyze independent (age, education, profession, previous experiences) and dependent (fear, anxiety) factors influencing patient choices.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

318Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
incidence of spinal anesthesia preference	To determine the incidence of spinal anesthesia preference after exposure to the visual information catalog	4 MONTH

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged 18-45
who are undergoing elective cesarean sections
and classified as ASA I-II according to the American Society of Anesthesiologists (ASA) scale

Exclusion Criteria:

patients under 18 or over 45 years old,
emergency cesareans,
preeclampsia,
cardiovascular disorders,
fetal abnormalities,
those not receiving spinal anesthesia or converted to general anesthesia during surgery,
those who refuse to participate in the study,
hospital clinical or administrative staff,
patients with psychiatric disorders

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Pregnant Women

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

The study will include 318 pregnant women aged 18-45 who are undergoing elective cesarean sections and classified as ASA I-II according to the American Society of Anesthesiologists (ASA) scale.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
ilke dolgun	Contact	+905555485632		ilkeser2004@gmail.com
ilke dolgun	Contact

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istinye Üniversity		Istanbul	Merkez Mahallesi	34250	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36742112	Result	Emadi SA, Gholipour Baradari A, Khademloo M, Abotorabi M, Hassanzadeh Kiabi F. Evaluating patients' choice of general and spinal anesthesia for elective cesarean section and associated factors: a descriptive study. Ann Med Surg (Lond). 2023 Jan 12;85(1):6-12. doi: 10.1097/MS9.0000000000000010. eCollection 2023 Jan.
39533188	Result