Status:
COMPLETED
Nonpharmacologic Reduction of Periprocedural Distress and Drug Use
Lead Sponsor:
Hypnalgesics, LLC
Collaborating Sponsors:
Tufts University
Conditions:
Dental Anxiety
Dental Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Objectives of this Phase I pilot trial are to provide data towards assessing and facilitating feasibility of a larger scale Phase II trial in which the effects of a calmative Comfort Talk® app can be ...
Detailed Description
The design is a single-blind, placebo controlled clinical trial to test the feasibility of the trial design assessing the ability of a Comfort Talk® app to nonpharmacologically reduce anxiety, pain, a...
Eligibility Criteria
Inclusion
- Scheduled to undergo a dental procedure at the Craniofacial Pain Center
- Able to hear, write and read in English, as the ComfortTalk® scripts, study scales and take-home diary are in English
- Able to operate a standard smart tablet or smart phone and have access to a smart tablet, smart phone at home, or computer-based app download
- Willing and able to give informed consent
Exclusion
- Known acute psychiatric disorder, such as multiple personalities which will be assessed on the medical history form
- Not meeting inclusion criteria
Key Trial Info
Start Date :
November 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT03328208
Start Date
November 22 2017
End Date
December 31 2018
Last Update
November 30 2021
Active Locations (2)
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1
Tufts University School of Dental Medicine
Boston, Massachusetts, United States, 02111
2
Hypnalgesics, LLC
Brookline, Massachusetts, United States, 02446