Nonpharmacologic Reduction of Periprocedural Distress and Drug Use

Completed · Not applicable · Has a placebo group

Conditions studied: Dental Anxiety, Dental Pain, Drug Use, Opioid Use

In brief

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 unequivocally evaluated. Towards this goal we will pursue following outcome parameters for Phase I: Feasibility/acceptability assessment: Primary outcome parameter: • ability to obtain complete on-site data sets from at least 90% of patients enrolled (with at least 40% from patients in the app group and at least 40% from patients in the control group). Secondary outcome parameters: * ability to enroll 60 patients by day 150 after initiation of recruitment in the clinic (=day 1) * obtain 38 packages of filled out diary cards (at least 16 from patients in the app group and at least 16 from patients in the control group) * 90% of patients in app group listen to app ≥5 min Phase II preparation primary outcome parameter • anxiety at the end of the waiting room time Secondary outcome parameters * pain the end of the waiting room time * anxiety during treatment * pain during treatment * anxiety during 1 week after treatment * pain during 1 week after treatment * use of units of sedatives and analgesics during 1 week after treatment (assessed by prescription at end of the visit) * patient satisfaction

Key facts

Study ID

NCT03328208

Run by

Hypnalgesics, LLC

People needed

72

Starts

2017-11-22

Expected to finish

2018-12-31

Last updated by the study team

2021-11-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Known acute psychiatric disorder, such as multiple personalities which will be assessed on the medical history form
• Not meeting inclusion criteria

Where it is running

• Tufts University School of Dental Medicine — Boston, Massachusetts, United States
• Hypnalgesics, LLC — Brookline, Massachusetts, United States

Full record on ClinicalTrials.gov

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