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Nonpharmacologic Reduction of Periprocedural Distress and Drug Use
NA trial testing Comfort Talk® app in Dental Anxiety in 72 participants. Completed in 31 December 2018.
| Lead sponsor | Hypnalgesics, LLC |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | other |
| Enrollment | 72 |
| Start date | 22 November 2017 |
| Primary completion | 30 October 2018 |
| Estimated completion | 31 December 2018 |
| Sites | 2 locations across United States |
Hypnalgesics, LLC
18 and older, any sex, with Dental Anxiety or Dental Pain. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Feasibility defined as the ability to obtain complete on-site data sets from at least 90% of participants enrolled (with at least 40% from patients in the app group and at least 40% from patients in the control group).
| Group | Value | 95% CI |
|---|---|---|
| Comfort Talk® App Group | 37 | |
| White Noise Group | 35 |
Feasibility measure defined as the ability to enroll 60 participants by day 150 after initiation of recruitment in the clinic (=day 1). Outcome measure are numbers of office days from the start of enrollment
| Group | Value | 95% CI |
|---|---|---|
| Comfort Talk® App Group | 106 | |
| White Noise Group | 106 |
Follow-up feasibility defined as obtaining 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)
| Group | Value | 95% CI |
|---|---|---|
| Comfort Talk® App Group | 15 | |
| White Noise Group | 11 |
Anxiety as measured by self-report on a 0-10 scale with 0=no anxiety at all and 10=worst anxiety possible; change from the beginning to the end of the waiting room time
| Group | Value | 95% CI |
|---|---|---|
| Comfort Talk® App Group | -0.81 | -1.21 – -0.41 |
| White Noise Group | -0.66 | -1.16 – 0.16 |
Pain as measured by self-report on a 0-10 scale with 0=no pain at all and 10=worst pain possible; change from the beginning to the end of the waiting room time
| Group | Value | 95% CI |
|---|---|---|
| Comfort Talk® App Group | -0.76 | -1.15 – -0.37 |
| White Noise Group | -0.26 | -0.56 – -0.05 |
Time course of pain as measured by self-report on a 0-10 scale with 0=no pain at all and 10=worst pain possible (average over 10 minute intervals)
| Group | Value | 95% CI |
|---|---|---|
| Comfort Talk® App Group | 2.5 | ± 2.0 |
| White Noise Group | 2.5 | ± 1.9 |
Time course of anxiety as measured by self-report on a 0-10 scale with 0=no anxiety at all and 10=worst anxiety possible (average over 10 minute intervals)
| Group | Value | 95% CI |
|---|---|---|
| Comfort Talk® App Group | 2.2 | ± 2.1 |
| White Noise Group | 2.0 | ± 1.7 |
Average maximal daily anxiety as measured daily by self-report on a 0-10 scale with 0=no anxiety at all and 10=worst anxiety possible
| Group | Value | 95% CI |
|---|---|---|
| Comfort Talk® App Group | 2.3 | ± 1.7 |
| White Noise Group | 2.3 | ± 1.9 |
Average of maximal daily pain as measured daily by self-report on a 0-10 scale with 0=no pain at all and 10=worst pain possible
| Group | Value | 95% CI |
|---|---|---|
| Comfort Talk® App Group | 2.9 | ± 1.4 |
| White Noise Group | 3.1 | ± 1.2 |
Participants receiving new prescriptions for drugs at the end of their visit for the subsequent week (alone or in combination opioids, non-opioid analgesics, anxiolytics, muscle relaxants, triptan, and/or anticonvulsants)
| Group | Value | 95% CI |
|---|---|---|
| Comfort Talk® App Group | 8 | |
| White Noise Group | 5 |
Patient satisfaction on a questionnaire at the end of the outpatient clinic visit, modeled after Press Ganey and averaged over 7 domains and groups. Assessment on Likert Scales from 1 (worst)-5 (best)
| Group | Value | 95% CI |
|---|---|---|
| Comfort Talk® App Group | 4.6 | 3.5 – 5.0 |
| White Noise Group | 4.6 | 3.3 – 5.0 |
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
1 peer-reviewed publication reference this trial (live from Europe PMC):
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