NCT04520100

Brief Summary

The overarching goal of this study is to enhance patient comfort during magnetic resonance (MR) exams by reducing anxiety and movement during the exam, thereby decreasing the time spent in magnetic resonance imaging (MRI) scanner and potentially improving patient satisfaction with the clinical care experience. This will be done with a trial focusing on studying the effects of clinical hypnosis and focused communication training on patient anxiety and other metrics during an MRI examination.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

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

July 31, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 20, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

October 2, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2022

Completed
Last Updated

May 5, 2022

Status Verified

May 1, 2022

Enrollment Period

1.3 years

First QC Date

July 31, 2020

Last Update Submit

May 3, 2022

Conditions

ClaustrophobiaAnxietyMagnetic Resonance Imaging

Outcome Measures

Primary Outcomes (3)

  • State and Trait Anxiety Inventory for Adults (STAI-AD) (Pre-MRI)

    Patient will complete the STAI-AD Short forms. Higher scores are correlated with higher anxiety (a worse outcome) and lower scores are correlated with less anxiety. Maximum score is 80 and minimum score is 20.

    Just prior to MRI on the same day as the MRI examination

  • State and Trait Anxiety Inventory for Adults (STAI-AD) (Post-MRI)

    Patient will complete the STAI-AD Short forms. Higher scores are correlated with higher anxiety (a worse outcome) and lower scores are correlated with less anxiety. Maximum score is 80 and minimum score is 20.

    Immediately after MRI

  • Patient Satisfaction Inventory

    Patient will complete the patient satisfaction survey.

    Immediately after MRI

Secondary Outcomes (3)

  • Movement/Image Repeat Rate

    During the MRI examination

  • Length of MRI examination

    During the MRI examination

  • Pulse Oximetry Vales

    During the MRI examination.

Study Arms (3)

MRI without intervention

NO INTERVENTION

No hypnosis during MRI and care by regular MR technologist

MRI with clinical hypnosis and regular MR tech

ACTIVE COMPARATOR

Hypnosis during MRI and care by regular MR technologist

Behavioral: Clinical Hypnosis performed by the PI

MRI with care by MR Tech trained in empathic communication

ACTIVE COMPARATOR

No hypnosis during MRI and care by MR technologist who have been trained in emphatic communication

Behavioral: Care by technician trained in empathic communication

Interventions

Clinical Hypnosis performed by the PIBEHAVIORAL

The patient will receive clinical hypnosis by the PI prior to examination and listen to recorded session during their MRI.

MRI with clinical hypnosis and regular MR tech
Care by technician trained in empathic communicationBEHAVIORAL

The patient will be taken care of by an MRI technician who has been previously trained in empathic communication.

MRI with care by MR Tech trained in empathic communication

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients over 18 years old, undergoing MRI at the UCH Outpatient Pavilion.
  • Are scheduled to undergo an MRI that does not require deep breath holds
  • English-speaker

You may not qualify if:

  • Patients under the age of 18 years old,
  • Diagnosis of active psychosis,
  • Diagnosis of delirium
  • Diagnosis of movement disorders
  • Those who lack mental capacity to complete the forms.
  • Scheduled to undergo MRI with deep breath holds.
  • Non-English speaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (3)

  • Lang EV, Yuh WT, Ajam A, Kelly R, Macadam L, Potts R, Mayr NA. Understanding patient satisfaction ratings for radiology services. AJR Am J Roentgenol. 2013 Dec;201(6):1190-5; quiz 1196. doi: 10.2214/AJR.13.11281.

    PMID: 24261356BACKGROUND

  • Norbash A, Yucel K, Yuh W, Doros G, Ajam A, Lang E, Pauker S, Mayr N. Effect of team training on improving MRI study completion rates and no-show rates. J Magn Reson Imaging. 2016 Oct;44(4):1040-7. doi: 10.1002/jmri.25219. Epub 2016 Apr 6.

    PMID: 27126735BACKGROUND

  • Simon EP. Hypnosis using a communication device to increase magnetic resonance imaging tolerance with a claustrophobic patient. Mil Med. 1999 Jan;164(1):71-2.

    PMID: 9922650BACKGROUND

MeSH Terms

Conditions

ClaustrophobiaAnxiety Disorders

Condition Hierarchy (Ancestors)

Phobic DisordersMental Disorders

Study Officials

  • Alexandra Chadderdon, PsyD

    University of Colorado Denver, Anschutz Medical Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2020

First Posted

August 20, 2020

Study Start

October 2, 2020

Primary Completion

January 23, 2022

Study Completion

January 23, 2022

Last Updated

May 5, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)