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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: Completed NA study, sponsored by Hypnalgesics.
NCT03328208 is a NA study that has completed, run by Hypnalgesics. The registered enrollment target is 72 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
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).
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 |
What the finished NCT03328208 record still lists
NCT03328208 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Comfort Talk® app is the first listed.
NCT03328208 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT03328208's enrollment target sits among peer trials
72 1089th of 2000 higher than 899 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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