NCT02586103

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2015

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

First Submitted

Initial submission to the registry

October 22, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 26, 2015

Completed
6 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

June 20, 2017

Status Verified

June 1, 2017

Enrollment Period

1.4 years

First QC Date

October 22, 2015

Last Update Submit

June 18, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Anxiety score

    Modified Yale Preoperative Anxiety Scale

    Immediately following MRI simulation

Study Arms (1)

MRI

Patients who undergo simulated practice MRI on the day of or prior to their scheduled MRI.

Device: MRI simulation

Interventions

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

MRI

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled for MRI with sedation or anesthesia.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

October 22, 2015

First Posted

October 26, 2015

Study Start

November 1, 2015

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

June 20, 2017

Record last verified: 2017-06

Locations