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NCT02586103 Clinical Trial

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

Magnetic Resonance Imaging Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02586103
Other study ID # IRB15-00894
Secondary ID
Status Completed
Phase N/A
First received October 22, 2015
Last updated June 18, 2017
Start date November 2015
Est. completion date April 2017

Study information
Verified date June 2017
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date April 2017
Est. primary completion date April 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• MRI simulation
It is not a working MRI machine but sounds and feels just like the real machine.

Locations
Country Name City State
United States Nationwide Children's Hospital Columbus Ohio

Sponsors (1)
Lead Sponsor Collaborator
Arlyne Thung

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Anxiety score Modified Yale Preoperative Anxiety Scale Immediately following MRI simulation
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