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Pilot Trial of Hypnosis and Enhanced Communication In Patients Undergoing MRI

Primary Purpose

Claustrophobia, Anxiety, Magnetic Resonance Imaging

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clinical Hypnosis performed by the PI
Care by technician trained in empathic communication
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Claustrophobia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • University of Colorado Anschutz Medical Campus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

MRI without intervention

MRI with clinical hypnosis and regular MR tech

MRI with care by MR Tech trained in empathic communication

Arm Description

No hypnosis during MRI and care by regular MR technologist

Hypnosis during MRI and care by regular MR technologist

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

Outcomes

Primary Outcome Measures

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.
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.
Patient Satisfaction Inventory
Patient will complete the patient satisfaction survey.

Secondary Outcome Measures

Movement/Image Repeat Rate
MRI technician will record the number of repeated acquisitions needed during the MRI exam.
Length of MRI examination
Length of MRI from 1st image to last image obtained will be obtained from the medical record.
Pulse Oximetry Vales
Patient's pulse oximetry values will be measured throughout the MRI .

Full Information

First Posted
July 31, 2020
Last Updated
May 3, 2022
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT04520100
Brief Title
Pilot Trial of Hypnosis and Enhanced Communication In Patients Undergoing MRI
Official Title
Pilot Trial of Hypnosis and Enhanced Communication Training to Reduce Anxiety, Improve Patient Satisfaction, and Decrease Movement for Patients Undergoing Magnetic Resonance Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 2, 2020 (Actual)
Primary Completion Date
January 23, 2022 (Actual)
Study Completion Date
January 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Magnetic resonance imaging (MRI) is an increasingly common imaging modality used for the diagnosis and treatment of disease. Given the closed bore nature of the MRI machine itself, the need to hold still within the imaging bore, the high noise level, vibrations and other uncomfortable sensations that can be experienced during MRI, anxiety and other claustrophobia-related symptoms are relatively frequently reported . These symptoms may result in premature termination/failure of the MRI examination, or excessive patient movement which can degrade image quality and lengthen the time needed to perform the examination. Additionally, patient satisfaction scores suffer due to these negative experiences during MRI. This is especially important, as radiology departments are major influencers in overall hospital patient satisfaction scores . Due to the substantial impact that anxiety and claustrophobia-related symptoms have on all aspects of MRI, the most common intervention provided to patients who report such symptoms are anxiolytic medications or sedation/anesthesia. These interventions can come at significant cost to patients and radiology departments and carry medical risks to the patient as well. Anxiolytic medications or sedation/anesthesia can lead to potential negative side effects, such as cardiopulmonary depression, hypotension, tachycardia, dystonic reactions, involuntary muscle movements . These adverse effects can even contribute to unsuccessful imaging themselves. Non-medical interventions, such as clinical hypnosis and enhanced communication strategies are not well studied in MR and have the potential to provide similar benefits of anxiolytic medications or sedation in terms of reducing movement artifacts and anxiety, but with far fewer side effects and safety concerns. For example, hypnosis can reduce anxiety and operating room time during radiological procedures , reduce amounts of analgesic used , and decrease behavioral issues related to claustrophobia during MRI . Additionally, enhanced communication strategies can reduce MRI no-show and study failure rates and improve ratings in national Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) . Thus, there is evidence to support the use of hypnosis and communication training during MRI in order to improve MR exam outcomes and patient outcomes. The investigators hypothesis is that patients who participate in hypnosis prior to MRI will experience less anxiety and demonstrate less movement during the exam. This will lead to improved overall patient satisfaction, reduction in image repeat rates and the overall time needed to perform the MRI. The investigators also hypothesize that patients who undergo MRI with a radiology technician who has received training in enhanced communication skills will experience less anxiety and demonstrate less movement during the exam. This will lead to improved overall patient satisfaction and reduction in image repeat rates and the overall time needed to perform the MRI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Claustrophobia, Anxiety, Magnetic Resonance Imaging

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MRI without intervention
Arm Type
No Intervention
Arm Description
No hypnosis during MRI and care by regular MR technologist
Arm Title
MRI with clinical hypnosis and regular MR tech
Arm Type
Active Comparator
Arm Description
Hypnosis during MRI and care by regular MR technologist
Arm Title
MRI with care by MR Tech trained in empathic communication
Arm Type
Active Comparator
Arm Description
No hypnosis during MRI and care by MR technologist who have been trained in emphatic communication
Intervention Type
Behavioral
Intervention Name(s)
Clinical Hypnosis performed by the PI
Intervention Description
The patient will receive clinical hypnosis by the PI prior to examination and listen to recorded session during their MRI.
Intervention Type
Behavioral
Intervention Name(s)
Care by technician trained in empathic communication
Intervention Description
The patient will be taken care of by an MRI technician who has been previously trained in empathic communication.
Primary Outcome Measure Information:
Title
State and Trait Anxiety Inventory for Adults (STAI-AD) (Pre-MRI)
Description
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.
Time Frame
Just prior to MRI on the same day as the MRI examination
Title
State and Trait Anxiety Inventory for Adults (STAI-AD) (Post-MRI)
Description
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.
Time Frame
Immediately after MRI
Title
Patient Satisfaction Inventory
Description
Patient will complete the patient satisfaction survey.
Time Frame
Immediately after MRI
Secondary Outcome Measure Information:
Title
Movement/Image Repeat Rate
Description
MRI technician will record the number of repeated acquisitions needed during the MRI exam.
Time Frame
During the MRI examination
Title
Length of MRI examination
Description
Length of MRI from 1st image to last image obtained will be obtained from the medical record.
Time Frame
During the MRI examination
Title
Pulse Oximetry Vales
Description
Patient's pulse oximetry values will be measured throughout the MRI .
Time Frame
During the MRI examination.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra Chadderdon, PsyD
Organizational Affiliation
University of Colorado Denver, Anschutz Medical Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24261356
Citation
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.
Results Reference
background
PubMed Identifier
27126735
Citation
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.
Results Reference
background
PubMed Identifier
9922650
Citation
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.
Results Reference
background

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Pilot Trial of Hypnosis and Enhanced Communication In Patients Undergoing MRI

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