Prospective Study Assessing the Validity of Y-PAS (Yale Preoperative Anxiety Scale) to Predict Patients Undergoing Magnetic Resonance Imaging Without the Use of Sedation/General Anesthesia

June 18, 2017 updated by: Arlyne Thung
The mYPAS (Modified Yale Preoperative Anxiety Scale) is a quick, easy, validated and "gold standard" assessment tool to measure pediatric anxiety in the perioperative period. Therefore the objective of the current prospective study is examine if the mY-PAS is an effective screening tool to differentiate patients who would succeed versus fail for MRI without sedation/anesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

80

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

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients scheduled for MRI with sedation or anesthesia.

Description

Inclusion Criteria:

  • all patients and parents who are willing to participate in the simulated practice MRI on the day of or prior to their scheduled MRI.

Exclusion Criteria:

  • patients/parents who refuse to go through the practice MRI sessions.

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
Intervention / Treatment
MRI
Patients who undergo simulated practice MRI on the day of or prior to their scheduled MRI.
Device: MRI simulation
It is not a working MRI machine but sounds and feels just like the real machine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety score
Time Frame: Immediately following MRI simulation
Modified Yale Preoperative Anxiety Scale
Immediately following MRI simulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arlyne Thung

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

November 1, 2015

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

October 22, 2015

First Submitted That Met QC Criteria

October 23, 2015

First Posted (Estimate)

October 26, 2015

Study Record Updates

Last Update Posted (Actual)

June 20, 2017

Last Update Submitted That Met QC Criteria

June 18, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • IRB15-00894

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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