Clinical trial NCT03328208: Nonpharmacologic Reduction of Periprocedural Distress and Drug Use
Official title: Nonpharmacologic Reduction of Periprocedural Pain, Anxiety, and Prescription Drug Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Anxiety
Dental Pain
Drug Use
Opioid Use
Keywords: Nonpharmacologic analgesia
Medical app
Relaxation
Lead sponsor: Hypnalgesics, LLC
Sponsor class: INDUSTRY
Collaborators: name: Tufts University
First posted: 2017-11-01
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single-blind placebo-controlled trial comparing a Comfort Talk® calmative app (App Group) with a white noise app (Control Group).
Primary purpose: OTHER

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

Detailed description: The design is a single-blind, placebo controlled clinical trial to test the feasibility of the trial design assessing the ability of a Comfort Talk® app to nonpharmacologically reduce anxiety, pain, and periprocedural drug use in individuals 18 years of age and older undergoing outpatient treatment in the Craniofacial Pain Center of the Tufts School of Dental Medicine.

The trial is a single-site pilot trial to assist in sample size estimation in a pivotal trial to test the hypothesis that listening to a Comfort Talk® app with calmative content reduces pain, anxiety, and post-procedural medication use.

Eligible patients at the Craniofacial Pain Center at the Tufts School of Dental Medicine (TUSDM) will be randomized to listen to a tablet containing a calmative Comfort Talk® app or app with white noise on an intent-to-treat basis. Their anxiety and pain measures will be recorded on validated 0-10 scales and before listening, at the end of the waiting room period, and every 10 minutes while on the dental chair.

All patients will be given a packet with diary cards to record their levels of anxiety, pain, and drug use daily for 7 days after their visit and asked to send those back. Subjects will be mailed a $25 check upon returning their diaries.

Patients randomized to the Comfort Talk® app will receive a download coupon for the app before leaving TUSDM, those randomized to the control condition (white noise) will receive a download coupon after they send in their diary cards.

Interventions and Duration

Approximately 1 hour and 15 minutes (Up to 30 minutes more than the scheduled standard of care visit, which will typically last up to 45 minutes):

Patient will be asked to come in ½ hour early before an already scheduled appointment. They will be taken to a private area, report their demographics, and if eligible consented and fill out a NIDA Quick Screen.

The participant will then be verbally asked to indicate his/her pain and anxiety levels on validated 0-10 scales. The research assistant will then hand the participant a tablet containing, depending on the group attribution, either the app (App Group) or white noise (Control Group) and will be shown how to operate the tablet.

Participant will then return to the clinic waiting area with the tablet and wait for their regularly scheduled appointment. The patient will be at liberty to when and for how long to listen. At the end of the waiting room period the participant will be queried again for their levels of pain and anxiety.

After the participant enters the treatment room, he or she will be able to continue to listen to the app or white noise on the tablet. The research assistant will ask the participant every 10 min to indicate their pain and anxiety levels. The research assistant will note the duration of chair time, the amount of lidocaine given, if any or which other medications were given during the appointment, and whether the dental practitioner prescribed opioid, prescription or non-prescription drugs at the end of the visit.

Before leaving home, the participant will be asked to fill out a satisfaction survey based on a modified Press Ganey Template. The participant will then receive a diary card on which to note pain, average and maximal pain as well its location, use of non-prescription, prescription, and opiate drugs, use of the app, and be provided pre-stamped envelopes. Patients will be asked to complete the diary daily before bedtime for 7 days.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Known acute psychiatric disorder, such as multiple personalities which will be assessed on the medical history form
* Not meeting inclusion criteria

Primary outcomes:
measure: Number of Participants With Complete On-Site Data Sets
timeFrame: Duration of outpatient clinic visit (up to 2 hrs)
Secondary outcomes:
measure: Number of Days to Enroll 60 Participants
timeFrame: Up to 150 days
measure: Number of Participants Returning Diary Card Packages
timeFrame: Up to 6 months
Other outcomes:
measure: Anxiety at the End of the Waiting Room Time (Change as Compared to Beginning of the Waiting Room Time)
timeFrame: Up to 60 min
measure: Pain the End of the Waiting Room Time (Change as Compared to Beginning of the Waiting Room Time)
timeFrame: Up to 60 min
measure: Pain During Dental Treatment
timeFrame: Up to 120 min
measure: Anxiety During Dental Treatment
timeFrame: Up to 120 min
measure: Average Maximal Anxiety During 1 Week After Dental Treatment
timeFrame: 7 days
measure: Average Maximal Pain During 1 Week After Treatment
timeFrame: 7 days
measure: Number of Participants Receiving New Prescriptions for Drugs
timeFrame: 7 days
measure: Patient Satisfaction
timeFrame: Up to 3 hrs
Locations:
city: Boston
country: United States
facility: Tufts University School of Dental Medicine
state: Massachusetts
city: Brookline
country: United States
facility: Hypnalgesics, LLC
state: Massachusetts
Study officials:
affiliation: Hypnalgesics, LLC
name: Elvira V Lang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: