The Effect of Preoperative Anxiety on Duration and Effica... | NCT03958578

Studies
The Effect of Preoperative Anxiety on Duration and Efficacy of Motor and Sensory Block in Spinal Anesthesia

NCT03958578

Sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Status

Completed

Last Update Posted

Nov 23, 2021Actual

Enrollment

90Actual

Phase

Not provided

Conditions

Anxiety

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

Nov 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2019Actual

Primary Completion Date

Dec 1, 2019Actual

Completion Date

Dec 1, 2019Actual

First Submitted Date

May 20, 2019

First Submission Date that Met QC Criteria

May 20, 2019

First Posted Date

May 22, 2019Actual

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

Nov 22, 2021

Last Update Posted Date

Nov 23, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yadigar Yılmaz, Medical Doctor, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyPrincipal Investigator

Lead Sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Spinal anaesthesia results in blockade of sympathetic efferent neurones. Patients with higher baseline sympathetic activation have been shown to have more marked hypotension after spinal anaesthesia. Anxiety causes generalized sympathetic activation. It was aimed to find the effect of preoperative anxiety on the duration and efficacy of neuraxial anaesthesia.

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

90Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
State-Trait Anxiety Inventory questionnaire	State-Trait Anxiety Inventory questionnaire is a direct psychological assessment of preoperative anxiety.	20-30 minutes.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients aged between 18 and 55 years.
ASA I-II
BMI 18-25

Exclusion Criteria:

Major surgery

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

It is planned to enroll healthy individuals undergoing elective surgery under spinal anaesthesia.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yadigar Yılmaz		Istanbul		34230	Turkey (Türkiye)