Reduction of Claustrophobia and Patient Motion After Training of MRI Personnel in Comfort TalkTM

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Tufts Medical Center
Boston Medical Center
Ohio State University
Information provided by (Responsible Party):
Hypnalgesics, LLC
ClinicalTrials.gov Identifier:
NCT01563198
First received: October 24, 2011
Last updated: March 22, 2012
Last verified: March 2012
  Purpose

Annually, an estimated 700,000 patients do not complete their scheduled MRI scans because of claustrophobia or inability to hold still. Training staff working in MRI facilities to provide Comfort TalkTM promises to enable patients to complete and obtain high quality imaging without medication, which will increase comfort and reduce sedation risks for the patients, and increase efficiency and reduce loss of revenue for the facilities.


Condition Intervention
Claustrophobia
Complication of Diagnostic Procedure
Behavioral: Comfort Talk

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Amelioration of Claustrophobia and Disruptive Patient Motion in MR Imaging

Further study details as provided by Hypnalgesics, LLC:

Primary Outcome Measures:
  • Change in non-completion rate of MRI scans from baseline at average of one year [ Time Frame: Average one year ] [ Designated as safety issue: No ]
    The sites will be followed for an average of one year after training in Comfort Talk and non-completion rates will be compared to the baseline values of non-completion.


Enrollment: 3
Study Start Date: August 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Comfort TalkTM Training
The MRI units of three clinical sites form the group. Their personnel will be trained to use Comfort TalkTm to help patients who are claustrophobic, anxious, and/or cannot lie still to complete their tests
Behavioral: Comfort Talk
Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training.
Other Names:
  • Self-hynotic relaxation
  • nonpharmacologic analgesia
  • nonpharmacologic anxiolysis
  • patient sedation without medication

Detailed Description:

Claustrophobia and disruptive patient motion are common impediments to MRI examination, but they may be prevented or ameliorated with a non-pharmacologic behavioral intervention administered by trained staff. The potential benefits of such an intervention are highly significant, considering that the alternatives are to cancel the study or administer sedation. Inability to complete their MRI scans adversely affects an estimated 700,000 patients every year in the US. These patients are either deprived of a diagnosis, subject to diagnostic delays, or are exposed to risks of pharmacologic sedation, including death. The imaging facilities in turn, typically cannot fill the suddenly vacated examination slots in time before the next scheduled patient and thus incur considerable lost revenue and efficiency. The long-term goal is to provide a validated, clinically feasible means for non-pharmacologic amelioration of claustrophobia and disruptive patient motion, achieved by training MRI staff to use advanced rapport skills and comforting language to help patients. Phase I will design and perform a formative evaluation of a Comfort TalkTM Training intervention so that definitive testing of the hypothesized benefits for the intervention can be accomplished in Phase II.

In Specific Aim 1 the Comfort TalkTM intervention sequence will be designed to include training in advanced rapport skills, using basic comforting language and avoiding negative language for all facility staff (including receptionists, technologists, nurses, and physicians). A core of licensed healthcare professionals will be taught how to guide patients in self-hypnotic relaxation techniques, using scripts, found to be safe and effective in the radiology department. Techniques are designed to easily integrate into the normal workflow without adding time. Training will include 2x8 hrs live at three test sites. Acceptance, observation of staff behavior, qualitative feedback, and rates of noncompletion will be used to assess efficacy of training, guide prototype development, and develop train-the-trainer materials. Using in-market piloting techniques, niche applications with their metrics will be explored to develop situation—specific supplemental materials. In Aim 2 an interactive web-based electronic platform will be developed to supplement training and provide post-training support. It will provide scenarios and practice applications, guided dialogue options, functions for online live interactive classes, and interface with Smartphones. The prototype will be beta-tested with 20 experts in hypnosis and refined through user input from the test sites. Aim 3 is to conduct a formative evaluation of the entire Comfort TalkTM intervention. Effects will be evaluated in 3-months intervals and compared to baseline performance. Criteria will include acceptance, qualitative feedback, content mastery, staff behavior, rates of noncompletion, patient recall and satisfaction. Additional metrics identified through in-market exploration will be analyzed for their potential as economic drivers and evaluation instruments.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Facilities performing MRI examinations
  • Facilities capturing data on noncompletion of MRI scans
  • Facilities willing to have their personnel trained
  • Facilities with personnel interested and willing to be trained
  • Facilities able to obtain IRB review
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01563198

Locations
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Boston Medical Center
Boston, Massachusetts, United States, 02118
Hypnalgesics, LLC
Brookline, Massachusetts, United States, 02446
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Hypnalgesics, LLC
Tufts Medical Center
Boston Medical Center
Ohio State University
Investigators
Principal Investigator: Elvira V Lang, MD Hypnalgesics, LLC
  More Information

Additional Information:
Publications:
Responsible Party: Hypnalgesics, LLC
ClinicalTrials.gov Identifier: NCT01563198     History of Changes
Other Study ID Numbers: 1R43AT0062696
Study First Received: October 24, 2011
Last Updated: March 22, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Hypnalgesics, LLC:
MRI departments and facilities
Noncompletion of MRI

Additional relevant MeSH terms:
Phobic Disorders
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 14, 2014