Preoperative Anxiety Evaluation: a New Visual Smileys Scale | NCT02667847

Studies
Preoperative Anxiety Evaluation: a New Visual Smileys Scale

NCT02667847

Sponsor

Cedars-Sinai Medical Center

Status

Completed

Last Update Posted

Feb 3, 2016Estimated

Enrollment

200Actual

Phase

Not provided

Conditions

Anxiety, Preoperative

Interventions

Not provided

Countries

United States

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

Feb 2016

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

Dec 2012

Primary Completion Date

Dec 2013Actual

Completion Date

Feb 2014Actual

First Submitted Date

Feb 26, 2015

First Submission Date that Met QC Criteria

Jan 28, 2016

First Posted Date

Jan 29, 2016Estimated

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

Feb 2, 2016

Last Update Posted Date

Feb 3, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Roya Yumul, M.D.,PhD., Corresponding Author, Cedars-Sinai Medical CenterPrincipal Investigator

Lead Sponsor

Cedars-Sinai Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

Preoperative anxiety is a complex clinical concept with both physiological and psychological consequences.

Detailed Description

This study looks at the need for a more user friendly, rapid tool for measuring preoperative anxiety, specifically by evaluating the visual smileys scale.

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

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Preoperative patients		Preoperative patients were asked to verbally rate their anxiety 1=on a scale from 0-10 and 2=using the new smiley scale

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anxiety level, as measured by verbal rating scale or visual smileys scale	in preoperative setting	up to 5 minutes

Secondary Outcomes

Measure	Description	Time Frame
scale preference	in preoperative setting, comparing verbal rating scale and visual smileys scale	up to 5 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 to 80 years old
undergoing surgery at Cedars Sinai Medical Center

Exclusion Criteria:

did not receive sedative or narcotic prior to the interview

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

200 patients undergoing surgery at Cedars Sinai Medical Center

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cedars-Sinai Medical Center		Los Angeles	California	90048	United States