MedTrace Logo

Nonpharmacologic Reduction of Periprocedural Distress and Drug Use

NCT03328208 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2021-11-30

Study results available
· View outcomes & findings →

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

Conditions

  • Dental Anxiety
  • Dental Pain
  • Drug Use
  • Opioid Use

Interventions

OTHER

Comfort Talk® app

Test app

OTHER

White Noise app

White Noise app built to mimic appearance of Comfort Talk® test app

Sponsors & Collaborators

  • Tufts University

    collaborator OTHER

  • Hypnalgesics, LLC

    lead INDUSTRY

Principal Investigators

  • Elvira V Lang, MD, PhD · Hypnalgesics, LLC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-22
Primary Completion
2018-10-30
Completion
2018-12-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03328208 on ClinicalTrials.gov