Pilot Trial of Hypnosis and Enhanced Communication In Patients Undergoing MRI

Not Applicable

Completed

• Conditions: Magnetic Resonance Imaging; Claustrophobia; Anxiety
• Interventions: Behavioral: Care by technician trained in empathic communication; Behavioral: Clinical Hypnosis performed by the PI

• Registration Number: NCT04520100
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study First Submitted: 2020-07-31
• Study First Submitted QC: 2020-08-17
• Study First Posted: 2020-08-20
• Study Start: 2020-10-02
• Primary Completion: 2022-01-23
• Study Completion: 2022-01-23
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-03
• Last Update Posted: 2022-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
MRI with care by MR Tech trained in empathic communication	Care by technician trained in empathic communication	No hypnosis during MRI and care by MR technologist who have been trained in emphatic communication
MRI with clinical hypnosis and regular MR tech	Clinical Hypnosis performed by the PI	Hypnosis during MRI and care by regular MR technologist

Primary Outcome Measures

Name	Time	Method
State and Trait Anxiety Inventory for Adults (STAI-AD) (Pre-MRI)	Just prior to MRI on the same day as the MRI examination	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)	Immediately after 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	Immediately after MRI	Patient will complete the patient satisfaction survey.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States