NCT06973486

Brief Summary

The main purpose of this research is to determine the causes of spinal anesthesia failures during cesarean section due to social, emotional and attitude factors towards surgery and to use this information to improve anesthesia practice.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

May 7, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 15, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

May 20, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2025

Completed
Last Updated

May 28, 2025

Status Verified

May 1, 2025

Enrollment Period

4 months

First QC Date

May 7, 2025

Last Update Submit

May 22, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • spinal anesthesia success rate

    Causes of spinal anesthesia failure during cesarean section related to social, emotional and attitude factors towards surgery

    20 minute

Interventions

Perceived Stress Scale (PSS) Pain Tolerance Scale (PRS) Surgical Anxiety Scale

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women over 18 years of age receiving spinal anesthesia

You may qualify if:

  • spinal anesthesia for term pregnancy and cesarean section
  • age ≥ 18
  • knowing the gestational week when participating in the study
  • answering all research questions
  • using the internet and social media tools

You may not qualify if:

  • mental and physical disability
  • diagnosis and treatment for psychiatric disorders
  • clinically significant physical health problemı

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.

Central Study Contacts

emine yılmaz güler

CONTACT

Study Design

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

Study Record Dates

First Submitted

May 7, 2025

First Posted

May 15, 2025

Study Start

May 20, 2025

Primary Completion

September 20, 2025

Study Completion

November 20, 2025

Last Updated

May 28, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share