Nonpharmacologic Reduction of Periprocedural Distress and Drug Use
Public ClinicalTrials.gov record NCT03328208. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Nonpharmacologic Reduction of Periprocedural Pain, Anxiety, and Prescription Drug Use
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT03328208
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 72 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 21, 2017
- Primary completion
- Oct 29, 2018
- Completion
- Dec 30, 2018
- Last update posted
- Nov 29, 2021
2017 – 2018
United States locations
- U.S. sites
- 2
- U.S. states
- 1
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Tufts University School of Dental Medicine | Boston | Massachusetts | 02111 | — |
| Hypnalgesics, LLC | Brookline | Massachusetts | 02446 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03328208, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 29, 2021 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03328208 live on ClinicalTrials.gov.