Nonpharmacologic Reduction of Periprocedural Pain and Anxiety in Dentistry

Dental Anxiety Clinical Trial

Official title: Nonpharmacologic Reduction of Periprocedural Pain, Anxiety, and Prescription Drug Use Phase II

Status Withdrawn

Clinical Trial Summary

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.

Clinical Trial Description

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 their 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. In Phase II, the investigators propose to further assess the impact of the Cft app in dentistry in accordance with an objective of the National Center for Complementary and Integrative Health(NCCIH) 2021-2025 Strategic Plan: testing the integration of a complementary approach into healthcare in a real-world setting.

The hypotheses are:

• 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.

The trial will be performed at Cambridge Health Alliance (CHA), Department of Dental Medicine, based on their high patient volume (>12,000 annual visits) and ethnically/racially diverse mix of patients. CHA is a nationally respected and innovative healthcare system and Massachusetts' largest safety net organization. CHA is committed to providing care for the undeserved and promoting interprofessional/cross-disciplinary care for all regardless of cultural, racial, or socioeconomic background. All patients of the dental clinic also receive their primary care through CHA, enabling electronic chart review regarding prior dental experiences, vital signs, and medical history.

The study will be carried out in accordance with an intent-to-treat comparison of the effects of a self-hypnotic relaxation Comfort Talk® (Cft) app versus a White Noise (WN), placebo-control app delivered through tablet in the dental waiting room. The comparison of test versus placebo apps is rare in the literature and enhances the rigor of the study. The same look and functionality of the Cft and WN apps will allow for as much blinding of the staff as physically feasible. The tablets' covers have A and B stickers with the designation for Cft and WN randomly determined. A research assistant (RA) will ask eligible patients to participate, consent, and fill out the patient's history based on the electronic record and patients' verbal information, and obtain their levels of pain and anxiety on a timed intake sheet. While patients fill out an anxiety questionnaire the RA retrieves and opens a sealed randomization envelope. The RA helps the patient to place an upper sternal patch for placement of a small ECG/heart rate monitor, hands them the assigned tablet, and goes over a print-out visual of generic tablet instructions to assure patients understand the usage of the apps without having to open the tablet to reveal their nature. The RA then invites the patient to engage with the assigned application as they like during the entire duration of their visit.

The RA keeps track of the time and the following data: pain and anxiety at baseline, at the end of the waiting room time, after entry in the treatment room, then every 10 minutes of the treatment, and at the end of the procedure; start of the treatment and steps such as use of a drill, anesthetics, or sedation if applicable, adverse events, and number and type of dental staff present. Upon treatment completion, patients and staff will fill out satisfaction with treatment questionnaires.

In the background, de-identified usage patterns of the Cft and WN apps will be electronically recorded through time-stamped capture. For analysis, they will be overlayed with the patient's timed subjective ratings and the electronically obtained heart rate data to identify outcome-critical elements of the app. This data will help identify the most beneficial app features which will provide the investigators with a unique opportunity to describe and better understand non-pharmacological interventions in general and will help inform future studies. ;

Related Conditions & MeSH terms

• Anxiety Disorders
• Dental Anxiety
• Dental Pain

• NCT number: NCT05194449
• Study type: Interventional
• Source: Hypnalgesics, LLC
• Status: Withdrawn
• Phase: N/A
• Start date: June 1, 2022
• Completion date: June 30, 2024