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ClaustrophobiaNCT01563198

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

A study testing Comfort Talk® in people with Claustrophobia and Complication of Diagnostic Procedure, run by Hypnalgesics, LLC at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?
Any age
What is being tested?
Comfort Talk®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
97,712 participants
Where
4 sitesUnited States
Study dates
Aug 2011to 17 Feb 2016
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

United States4 sites
  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Hypnalgesics, LLC

    Brookline, Massachusetts, 02446

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: Amelioration of Claustrophobia and Disruptive Patient Motion in MR Imaging

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.

Read the 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 Talk® 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 Talk® 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.

Being tested
Comfort Talk®
Keywords
MRI departments and facilities, Noncompletion of MRI
Medical subject headings
Claustrophobia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Comfort Talk®Behavioural

    Also called Self-hypnotic relaxation, nonpharmacologic analgesia, nonpharmacologic anxiolysis, patient sedation without medication

    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.

Study groups in NCT01563198
Study groupRoleWhat they receive
Comfort Talk® TrainingExperimentalThe 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
Receives: Behavioral: Comfort Talk®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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

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

Secondary outcomes (1)
  1. Change in No-Show Rates of Patients From the Average of the Baseline Year to the Average of One Year Post Training

    The sites will be followed for an average of one year after training in Comfort Talk and no-show rates will be compared to the baseline values of non-completion among all scheduled patients which were also collected over 1 year.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2012 (estimated)
  2. Study startAug 2011
  3. Primary completionJul 2015
  4. Study completion17 Feb 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
97,712 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01563198
Sponsor's protocol ID
1R43AT0062696
Status last verified
Apr 2017
First submitted
24 Oct 2011
Last updated
14 Apr 2017
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19734060
  • 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.

    PubMed 10801169
  • 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.

    PubMed 27126735
  • 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.

    PubMed 24261356

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