N/A
Completed N=49,733
Reduction of Claustrophobia and Patient Motion After Training of MRI Personnel in Comfort TalkTM
Claustrophobia · Complication of Diagnostic Procedure
Source: ClinicalTrials.gov NCT01563198 ↗
Enrolled (actual)
49,733
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: 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) — 10; -3.3 Percentage of participants — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
10; -3.3 | <0.0001 sig |
| PRIMARY 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) |
1.4; -0.9 | <0.0001 sig |
| SECONDARY Change in No-Show Rates of Patients From the Average of the Baseline Year to the Average of One Year Post Training |
8.7; -2.5 | <0.0001 sig |
Eligibility 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01563198). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.