Nonpharmacologic Reduction of Periprocedural Distress and Drug Use

NCT03328208 | Completed Results DMC

• 1 other identifier: R43AT009517
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Nonpharmacologic analgesia; Medical app; Relaxation

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Complete On-Site Data Sets

  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).

  Duration of outpatient clinic visit (up to 2 hrs)

Secondary Outcomes (2)

• Number of Days to Enroll 60 Participants

  Up to 150 days

• Number of Participants Returning Diary Card Packages

  Up to 6 months

Other Outcomes (8)

• Anxiety at the End of the Waiting Room Time (Change as Compared to Beginning of the Waiting Room Time)

  Up to 60 min

• Pain the End of the Waiting Room Time (Change as Compared to Beginning of the Waiting Room Time)

  Up to 60 min

• Pain During Dental Treatment

  Up to 120 min

Study Arms (2)

Comfort Talk® App Group

EXPERIMENTAL

Patients will receive a tablet preloaded with the Comfort Talk® app in the dental waiting room on an intent-to-treat basis. They can listen as much or as little as they wish during waiting and during their dental treatment. Upon departure, they will receive a download coupon for the app for home use.

Other: Comfort Talk® app

White Noise Group

ACTIVE COMPARATOR

Patients will receive a tablet preloaded with a white noise app in the dental waiting room on an intent-to-treat basis. They can listen as much or as little as they wish during waiting and during their dental treatment.

Other: White Noise app

Interventions

Comfort Talk® app OTHER

Test app

Also known as: Relaxation app

Comfort Talk® App Group

White Noise app OTHER

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

Also known as: Control app

White Noise Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled to undergo a dental procedure at the Craniofacial Pain Center
• Able to hear, write and read in English, as the ComfortTalk® scripts, study scales and take-home diary are in English
• Able to operate a standard smart tablet or smart phone and have access to a smart tablet, smart phone at home, or computer-based app download
• Willing and able to give informed consent

You may not qualify if:

• Known acute psychiatric disorder, such as multiple personalities which will be assessed on the medical history form

Sponsors & Collaborators

• Hypnalgesics, LLC: lead
• Tufts University: collaborator

Study Sites (2)

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

Location

Hypnalgesics, LLC

Brookline, Massachusetts, 02446, United States

Location

MeSH Terms

Conditions

Toothache

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This was a feasibility study and as such was not powered to find differences in all domains.

Results Point of Contact

• Title: Elvira V. Lang, MD, CEO
• Organization: Hypnalgesics, LLC

drevlang@comforttalk.com

6177349087

Study Officials

• Elvira V Lang, MD, PhD

  Hypnalgesics, LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The four tablets used in the study will be labeled A,B,C,D and will be preloaded with the app or white noise by the Hypnalgesics, LLC in randomized sequence. Personnel at TUSDM will not be aware which tablet presents test or control content. The opening screen and option screen of the white noise control app will use the same color scheme and lay-out as the one of the test Comfort Talk app. The statistical team will receive the encoded data entries and will not be informed about the content of the tablets until all analyses are completed. Since they also will not have direct contact with the study patients they are also not at risk of becoming unblinded during app use by the patients. At the end of their visit, patients will receive a sealed envelope which according to their number will either contain a download coupon for the app for home use or a thank you note. To maintain blinding, all patients who send their diaries back will receive a download coupon.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a single-blind placebo-controlled trial comparing a Comfort Talk® calmative app (App Group) with a white noise app (Control Group).

Study Record Dates

• First Submitted: October 21, 2017
• First Posted: November 1, 2017
• Study Start: November 22, 2017
• Primary Completion: October 30, 2018
• Study Completion: December 31, 2018
• Last Updated: November 30, 2021
• Results First Posted: March 4, 2020

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)