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.
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
- Conditions the study is for
- Claustrophobia, Complication of Diagnostic Procedure
- What is being tested?
- Comfort Talk®
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Comfort Talk® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
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.
- First posted26 Mar 2012 (estimated)
- Study startAug 2011
- Primary completionJul 2015
- Study completion17 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ClaustrophobiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hypnalgesics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tufts Medical Center, Boston Medical Center, Ohio State University
- Responsible party
- Sponsor
- Investigators
- Elvira V Lang, MD, Principal investigator, Hypnalgesics, LLC
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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 19734060Lang 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 10801169Norbash 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 27126735Lang 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