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

NCT01563198 | Completed Results

• 1 other identifier: 1R43AT0062696
• Study Type: interventional
• Target: 97,712
• Locations: 1 country
• Sites: 4

Brief Summary

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 Talk® 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.

Conditions

Claustrophobia; Complication of Diagnostic Procedure

Keywords

MRI departments and facilities; Noncompletion of MRI

Outcome Measures

Primary Outcomes (2)

• Change in Non-completion Rate of MRI Scans From the Average of the Baseline Year to the Average of One Year Post Training (All Scheduled Patients)

  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 among all scheduled patients.

  Baseline average of one year plus post training average one year = 2 years

• Change in Non-completion Rate of MRI Scans From the Average of the Baseline Year to the Average of One Year Post Training (Showing-Up Patients Only)

  The change in non-completion rate of MRI scans, obtained for the year prior to Comfort Talk® training at baseline, to the average one year post training was assessed

  Baseline average of one year plus post training average one year = 2 years

Secondary Outcomes (1)

• Change in No-Show Rates of Patients From the Average of the Baseline Year to the Average of One Year Post Training

  Baseline average of one year plus post training average one year = 2 years

Study Arms (1)

Comfort Talk® Training

EXPERIMENTAL

The MRI units of three clinical sites form the group. Their personnel will be trained to use Comfort Talk® to help patients who are claustrophobic, anxious, and/or cannot lie still to complete their tests

Behavioral: Comfort Talk®

Interventions

Comfort Talk® BEHAVIORAL

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.

Also known as: Self-hypnotic relaxation, nonpharmacologic analgesia, nonpharmacologic anxiolysis, patient sedation without medication

Comfort Talk® Training

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Facilities not performing MRI examinations
• Facilities not capturing data on noncompletion of MRI scans
• Facilities not willing to have their personnel trained
• Facilities unable to obtain IRB review

Sponsors & Collaborators

• Hypnalgesics, LLC: lead
• Tufts Medical Center: collaborator
• Boston Medical Center: collaborator
• Ohio State University: collaborator

Study Sites (4)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Hypnalgesics, LLC

Brookline, Massachusetts, 02446, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Publications (4)

• Lang EV, Ward C, Laser E. Effect of team training on patients' ability to complete MRI examinations. Acad Radiol. 2010 Jan;17(1):18-23. doi: 10.1016/j.acra.2009.07.002. Epub 2009 Sep 5.

  PMID: 19734060 BACKGROUND

• Lang EV, Benotsch EG, Fick LJ, Lutgendorf S, Berbaum ML, Berbaum KS, Logan H, Spiegel D. Adjunctive non-pharmacological analgesia for invasive medical procedures: a randomised trial. Lancet. 2000 Apr 29;355(9214):1486-90. doi: 10.1016/S0140-6736(00)02162-0.

  PMID: 10801169 BACKGROUND

• 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: 27126735 RESULT

• 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: 24261356 RESULT

Related Links

• Explanation of Comfort TalkTM and access to Post-Training Support Module
• Sponsor website and background information; description of techniques used

MeSH Terms

Conditions

Claustrophobia

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Results Point of Contact

• Title: Elvira V. Lang, MD (PI of SBIR grant)
• Organization: Hypnalgesics, LLC d/b/a Comfort Talk

drevlang@gmail.com

617 734 9087

Study Officials

• Elvira V Lang, MD

  Hypnalgesics, LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2011
• First Posted: March 26, 2012
• Study Start: August 1, 2011
• Primary Completion: July 1, 2015
• Study Completion: February 17, 2016
• Last Updated: April 14, 2017
• Results First Posted: April 14, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)