NCT02667847

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2015

Completed
11 months until next milestone

First Posted

Study publicly available on registry

January 29, 2016

Completed
Last Updated

February 3, 2016

Status Verified

February 1, 2016

Enrollment Period

1 year

First QC Date

February 26, 2015

Last Update Submit

February 2, 2016

Conditions

Anxiety, Preoperative

Keywords

preoperative anxiety assessmentlevels of preoperative anxiety using two different scales

Outcome Measures

Primary Outcomes (1)

  • Anxiety level, as measured by verbal rating scale or visual smileys scale

    in preoperative setting

    up to 5 minutes

Secondary Outcomes (1)

  • scale preference

    up to 5 minutes

Study Arms (1)

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

200 patients undergoing surgery at Cedars Sinai Medical Center

You may qualify if:

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

You may not qualify if:

  • did not receive sedative or narcotic prior to the interview

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

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

Study Record Dates

First Submitted

February 26, 2015

First Posted

January 29, 2016

Study Start

December 1, 2012

Primary Completion

December 1, 2013

Study Completion

February 1, 2014

Last Updated

February 3, 2016

Record last verified: 2016-02

Locations

US(1)