N/A N=72 Randomized Triple-blind Other

Nonpharmacologic Reduction of Periprocedural Distress and Drug Use

Dental Anxiety · Dental Pain · Drug Use · Opioid Use

Bottom Line

View on ClinicalTrials.gov: NCT03328208 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2020

Primary outcome: Primary: Number of Participants With Complete On-Site Data Sets — 37; 35 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Comfort Talk® app (Other); White Noise app (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hypnalgesics, LLC
Primary completion: Oct 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Complete On-Site Data Sets	37; 35	—
SECONDARY Number of Days to Enroll 60 Participants	106; 106	—
SECONDARY Number of Participants Returning Diary Card Packages	15; 11	—

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 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

Eligibility Criteria

Inclusion Criteria

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 Criteria

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

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Data sourced from ClinicalTrials.gov (NCT03328208). 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.