Causes of Spinal FailureNCT06973486
Causes of Spinal Failure in Cesarean Section
An observational study of Causes of Spinal Failure, run by Haseki Training and Research Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Causes of Spinal Failure
- What is being tested?
- psychometric scales
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2025to 20 Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women over 18 years of age receiving spinal anesthesia
Who may be able to join
- 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
Who cannot join
- mental and physical disability
- diagnosis and treatment for psychiatric disorders
- clinically significant physical health problemı
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effects of Social, Emotional and Attitudinal Dynamics on Spinal Anesthesia Outcomes in Cesarean Delivery
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.
- Conditions
- Causes of Spinal Failure
- Being tested
- psychometric scales
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychometric scalesBehavioural
Perceived Stress Scale (PSS) Pain Tolerance Scale (PRS) Surgical Anxiety Scale
What is being measured
The primary outcome is the main question the study is designed to answer.
spinal anesthesia success rate
Causes of spinal anesthesia failure during cesarean section related to social, emotional and attitude factors towards surgery
Measured: 20 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start20 May 2025 (estimated)
- Primary completion20 Sep 2025 (estimated)
- Study completion20 Nov 2025 (estimated)
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 Causes of Spinal FailureStudies of the same condition, open and under way.
- 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
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Yilmaz Guler, Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06973486
- Sponsor's protocol ID
- SF-2019
- Status last verified
- May 2025
- First submitted
- 7 May 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24141714
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Social, Emotional and Attitudinal Dynamics on Spinal Anesthesia Outcomes in Cesarean Delivery
- ClinicalTrials.gov ID
- NCT06973486
- Acronym / sponsor ID
- SF-2019
- Conditions
- Causes of Spinal Failure
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- 20 May 2025 (estimated)
- Primary completion
- 20 Sep 2025 (estimated)
- Study completion
- 20 Nov 2025 (estimated)
- First posted
- 15 May 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women over 18 years of age receiving spinal anesthesia
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- mental and physical disability
- diagnosis and treatment for psychiatric disorders
- clinically significant physical health problemı
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 |
|---|---|---|
| psychometric scalesPerceived Stress Scale (PSS) Pain Tolerance Scale (PRS) Surgical Anxiety Scale | Behavioural | – |
Primary outcome
spinal anesthesia success rate
Time frame: 20 minute
Causes of spinal anesthesia failure during cesarean section related to social, emotional and attitude factors towards surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Results publication: PubMed 24141714World 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.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Causes of Spinal Failure, run by Haseki Training and Research Hospital.
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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact emine yılmaz güler (905054525261, dr.emine.yilmaz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
spinal anesthesia success rate (time frame: 20 minute). 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 NCT06973486, 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 May 2025.