- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02667847
Preoperative Anxiety Evaluation: a New Visual Smileys Scale
February 2, 2016 updated by: Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center
Preoperative anxiety is a complex clinical concept with both physiological and psychological consequences.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
200 patients undergoing surgery at Cedars Sinai Medical Center
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety level, as measured by verbal rating scale or visual smileys scale
Time Frame: up to 5 minutes
|
in preoperative setting
|
up to 5 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
scale preference
Time Frame: up to 5 minutes
|
in preoperative setting, comparing verbal rating scale and visual smileys scale
|
up to 5 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2012
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
February 1, 2014
Study Registration Dates
First Submitted
February 26, 2015
First Submitted That Met QC Criteria
January 28, 2016
First Posted (Estimate)
January 29, 2016
Study Record Updates
Last Update Posted (Estimate)
February 3, 2016
Last Update Submitted That Met QC Criteria
February 2, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00030220
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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