Nonpharmacologic Reduction of Periprocedural Pain and Anxiety in Dentistry

Sponsor

Hypnalgesics, LLC (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05194449

Collaborator

Cambridge Health Alliance (Other)

150

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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. Our 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), we 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, we 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.

Condition or Disease	Intervention/Treatment	Phase
Dental Anxiety Dental Pain Root Work	Other: Comfort Talk® App Other: Placebo App	N/A

Detailed Description

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.

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 min 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 us with a unique opportunity to describe and better understand non-pharmacological interventions in general and will help inform future studies.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This is a single-blind placebo-controlled trial comparing a Comfort Talk® calmative app (Cft Group) with a white noise app (WN, Control Group).This is a single-blind placebo-controlled trial comparing a Comfort Talk® calmative app (Cft Group) with a white noise app (WN, Control Group).

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Two iPad tablets used in the study will be labeled A and B and will be preloaded with the app or white noise by the Hypnalgesics, LLC in randomized sequence. Personnel at CHA 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

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Comfort Talk® App (Cft) Group Mobile app with elements of relaxation, self-hypnosis, and reframing of distress	Other: Comfort Talk® App 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 Names: Self-hypnotic relaxation app Test app
Placebo Comparator: Placebo Group Mobile app with white noise choices having the same looks and functionality as the active Comfort Talk® 1st app	Other: Placebo App 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 Names: White noise app

Arm

Intervention/Treatment

Experimental: Comfort Talk® App (Cft) Group

Mobile app with elements of relaxation, self-hypnosis, and reframing of distress

Other: Comfort Talk® App

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 Names:

Self-hypnotic relaxation app

Test app

Placebo Comparator: Placebo Group

Mobile app with white noise choices having the same looks and functionality as the active Comfort Talk® 1st app

Other: Placebo App

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 Names:

White noise app

Outcome Measures

Primary Outcome Measures

Anxiety during the dental visit (Change as Compared to Beginning of the Waiting Room Time) [Up to 180 min]
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 min on the dental chair, and after treatment completion
Pain during the dental visit (Change as Compared to Beginning of the Waiting Room Time) [Up to 180 min]
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 min on the dental chair, and after treatment completion

Secondary Outcome Measures

Adverse events [Up to 180 min]
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)
Chair Time [Up to 180 min]
The time the patent will be on the dental treatment chair
Staff Time [Up t 180 min]
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.
Patient Satisfaction [10 min]
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.
Staff Satisfaction [10 min]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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