Anxiety Level of Child and Parents During Preoperative An... | NCT02201680

Studies
Anxiety Level of Child and Parents During Preoperative Anesthesia Evaluation

NCT02201680

Sponsor

Istanbul University

Status

Completed

Last Update Posted

Jul 28, 2014Estimated

Enrollment

117Actual

Phase

Not provided

Conditions

Anxiety State
Parent
Child

Interventions

Not provided

Countries

Not provided

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

ID	Type	Description	Link
31130	Other Identifier	Cerrahpasa Medical Faculty Clinical Trials Ethics Committee

Status Module

Record Verification Date

Jul 2014

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

Jun 2012

Primary Completion Date

Aug 2013Actual

Completion Date

Sep 2013Actual

First Submitted Date

Jul 12, 2014

First Submission Date that Met QC Criteria

Jul 24, 2014

First Posted Date

Jul 28, 2014Estimated

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

Jul 24, 2014

Last Update Posted Date

Jul 28, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Appreciation of preoperative anxiety in children is important for the anesthesiologist.
Several factors defined to effect the anxiety levels preoperatively in children such as , age, previous medical encounters , education level and parental anxiety. 3. This information was tested for Turkish children during the preoperative anesthetic evaluation.

Detailed Description

Before the planned surgery all children accompanying parents filled a questionnaire about the demographics, marital status, economical conditions, education level and other diseases and operations in the family.
Both the parent and child filled State and Trait Anxiety tests specially prepared for adults Spielberger Anxiety tests and children defined and validation tests had already been proven.

Statistical analysis performed for evaluation.

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

117Actual

Label	Type	Description	Intervention Names
parents and children		Anxiety tests

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
children state anxiety	Anxiety scores were filled within 1 hour no further evalution was performed.	1 hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Legible

Exclusion Criteria:

Illegible due to lack of education or eye diseases

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Children planned to undergo surgical procedures or diagnostic procedures under general anesthesia

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rovnat Babazade, M.D.	Istanbul University Cerrahpaşa Medical Faculty	Principal Investigator
Levent Kayaalp, Prof. Dr.	Private Practice	Principal Investigator
Gurcan Gungor, M.D.	Istanbul University	Principal Investigator
Burak Dogangun, Asoc. Prof	Istanbul University	Principal Investigator

Locations

Not provided