Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03328208 · ClinicalTrials.gov registry record · NA
Nonpharmacologic Reduction of Periprocedural Distress and Drug Use
A NA study, sponsored by Hypnalgesics.
- Completed
- Registry status
- NA
- Development phase
- 72
- Enrollment target
NCT03328208 is a NA study that has completed, run by Hypnalgesics. The registered enrollment target is 72 participants.
The verdict
NCT03328208, a NA study, has completed, sponsored by Hypnalgesics.
- COMPLETED
- Registry status
- NA
- Development phase
- 72 participants
- Enrollment target
Study 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
Interventions
- OTHER Comfort Talk® app
- OTHER White Noise app
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2017-11-22 |
| Est. Completion | 2018-12-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03328208
The ClinicalTrials.gov registry entry for NCT03328208 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hypnalgesics, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Comfort Talk® app is the first listed.
NCT03328208 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03328208 about?
NCT03328208 is a clinical study titled "Nonpharmacologic Reduction of Periprocedural Distress and Drug Use". 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...
What is the current status of trial NCT03328208?
This trial is currently completed. It is a NA study. The enrollment target is 72 participants. The study started on 2017-11-22. Estimated completion is 2018-12-31.
What interventions are being tested in trial NCT03328208?
The interventions under investigation include: Comfort Talk® app (OTHER), White Noise app (OTHER).
Who is sponsoring clinical trial NCT03328208?
This trial is sponsored by Hypnalgesics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.