Nonpharmacologic Reduction of Periprocedural Distress and Drug Use

Study Overview
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Brief Summary
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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
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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.

Official Title
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Nonpharmacologic Reduction of Periprocedural Pain, Anxiety, and Prescription Drug Use

Conditions
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Dental Anxiety, Dental Pain, Drug Use, Opioid Use

Intervention / Treatment
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* Other: Comfort Talk® app
* Other: White Noise app


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Comfort Talk® App Group<br>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<br>* Test app<br>* Other names: Relaxation app;|
| Active Comparator: White Noise Group<br>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<br>* White Noise app built to mimic appearance of Comfort Talk® test app<br>* Other names: Control app;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Days to Enroll 60 Participants | Feasibility measure defined as the ability to enroll 60 participants by day 150 after initiation of recruitment in the clinic (=day 1). Outcome measure are numbers of office days from the start of enrollment | Up to 150 days | 
| Number of Participants Returning Diary Card Packages | Follow-up feasibility defined as obtaining 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) | Up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nonpharmacologic analgesia, Medical app, Relaxation