Dental Anxiety Clinical Trial
Official title:
Nonpharmacologic Reduction of Periprocedural Pain, Anxiety, and Prescription Drug Use Phase II
NCT number | NCT05194449 |
Other study ID # | R44AT009517 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2022 |
Est. completion date | June 30, 2024 |
Verified date | March 2023 |
Source | Hypnalgesics, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Dental pain and anxiety are usually managed by local anesthetics and sedatives, but patient anxiety and fear of pain remain common and adversely affect oral health behavior and outcomes. The long-term goal is to provide a validated behavioral alternative/adjunct for managing dental anxiety and pain through a commercial Comfort Talk® (Cft) app. Such an application should benefit the patients undergoing the >300 million dental procedures per year in the US alone. In Phase I (Clinical Trials Identifier NCT03328208), the investigators designed such an app based on short Comfort Talk® scripts and snippets that, when spoken live by trained personnel in our prior large-scale clinical trials, reduced pain, anxiety, and drug use during invasive procedures, and when used practice-wide, improved patient attendance, throughput, and economics. In Phase I, the Cft app significantly reduced pain and anxiety in the dental waiting room. In Phase II, the investigators propose to further assess its impact. We hypothesize that: - The Cft app reduces pain and anxiety in the waiting room - The Cft app improves the patient experience and cooperation during dental treatment - The Cft app improves operations and economics of dental practices - Heart rate tracings are helpful in identifying outcome-critical app elements 150 patients scheduled for root canals or dental implants will receive in randomized sequence the Cft app or a placebo white noise app in the dentistry waiting room of Cambridge Health Alliance. Anxiety and pain will be measured subjectively on validated scales (0-no anxiety/no pain at all; 10-worst anxiety/pain possible) before listening and throughout the visit. Heart rate (HR) and ECG will be continuously recorded to assess adverse events and, in the absence of a validated biomarker for pain and anxiety, serve as an exploratory physiologic indicator of distress. Usage patterns of the Cft and the placebo apps will be established electronically through time-stamped background capture, de-identified, and uploaded to a database along with the corresponding HR recordings and overlayed with the patient's subjective ratings and procedure steps to identify outcome-critical elements of the app. We will record chair-time, staff-time, use of anesthetics and sedatives, if applicable, and patient and staff satisfaction, supplemented by bulk data acquired from other practices that use a co-branded version of the app, to determine the economic impact of the Cft app.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Scheduled to undergo a root canal or dental implant procedure at Cambridge - Health Alliance - 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 - 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 - Implanted cardiac medical device - Not meeting inclusion criteria |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hypnalgesics, LLC | Cambridge Health Alliance |
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anxiety during the dental visit (Change as Compared to Beginning of the Waiting Room Time) | Anxiety as measured by self-report on a 0-10 scale with 0=no anxiety at all and 10=worst anxiety possible; change from the beginning to the end of the waiting room time, measured before listening to the app, at the end of the waiting room, every 10 minutes on the dental chair, and after treatment completion | Up to 180 minutes | |
Primary | Pain during the dental visit (Change as Compared to Beginning of the Waiting Room Time) | Pain as measured by self-report on a 0-10 scale with 0=no pain at all and 10=worst pain possible; change from the beginning to the end of the waiting room time, measured before listening to the app, at the end of the waiting room, every 10 minutes on the dental chair, and after treatment completion | Up to 180 minutes | |
Secondary | Adverse events | Observable adverse events such as fainting, hemodynamics instability and those detected post visit by analysis of ECG/heart rate recordings (de novo bradycardia, tachycardia, arrhythmia, abnormal ECG changes) | Up to 180 minutes | |
Secondary | Chair Time | The time the patient will be on the dental treatment chair | Up to 180 minutes | |
Secondary | Staff Time | How long and which kind of staff personnel interacted with the patient during the visit (e.g., dentist, assistant, secretary) for assessment of the economic impact. | Up to 180 minutes | |
Secondary | Patient Satisfaction | The survey uses a 1-5 scale (1=very poor, 5=very well) and asks how the staff treated the patient, how well the staff worked together to provide care, how well the patient's pain was controlled, how well the staff did everything to help with their pain, how to rate the overall care, how well the tablet affected the way the patient felt, and whether the patient would recommend the facility. | 10 minutes | |
Secondary | Staff Satisfaction | Staff assessment will use a questionnaire piloted in Phase I assessing technical difficulty of the dental treatment, patient cooperation, perceived patient comfort, staff comfort, help perceived by app use, and overall staff satisfaction on a 1-4 Likert scale (not at all, a little, somewhat, a lot). | 10 minutes |
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