Clinical trial NCT05194449: Nonpharmacologic Reduction of Periprocedural Pain and Anxiety in Dentistry
Official title: Nonpharmacologic Reduction of Periprocedural Pain, Anxiety, and Prescription Drug Use Phase II
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Dental Anxiety
Dental Pain
Root Work
Keywords: Nonpharmacologic analgesia
Medical app
Relaxation
Hypnosis
Lead sponsor: Hypnalgesics, LLC
Sponsor class: INDUSTRY
Collaborators: name: Cambridge Health Alliance
First posted: 2022-01-18
Enrollment: 0
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 (Cft Group) with a white noise app (WN, Control Group).
Primary purpose: OTHER

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. 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Anxiety during the dental visit (Change as Compared to Beginning of the Waiting Room Time)
timeFrame: Up to 180 minutes
measure: Pain during the dental visit (Change as Compared to Beginning of the Waiting Room Time)
timeFrame: Up to 180 minutes
Secondary outcomes:
measure: Adverse events
timeFrame: Up to 180 minutes
measure: Chair Time
timeFrame: Up to 180 minutes
measure: Staff Time
timeFrame: Up to 180 minutes
measure: Patient Satisfaction
timeFrame: 10 minutes
measure: Staff Satisfaction
timeFrame: 10 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Hypnalgesics, LLC d/b/a Comfort Talk®
name: Evira V Lang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lang EV, Jackson W, Senn P, Aroni DKK, Finkelman MD, Corino TA, Conway G, Kulich RJ. Efficacy of a Self-Hypnotic Relaxation App on Pain and Anxiety in a Randomized Clinical Trial: Results and Considerations on the Design of Active and Control Apps. Int J Clin Exp Hypn. 2021 Apr-Jun;69(2):277-295. doi: 10.1080/00207144.2021.1883988. Epub 2021 Mar 16.
citation: Lang EV, Benotsch EG, Fick LJ, Lutgendorf S, Berbaum ML, Berbaum KS, Logan H, Spiegel D. Adjunctive non-pharmacological analgesia for invasive medical procedures: a randomised trial. Lancet. 2000 Apr 29;355(9214):1486-90. doi: 10.1016/S0140-6736(00)02162-0.
citation: Lang EV, Berbaum KS, Faintuch S, Hatsiopoulou O, Halsey N, Li X, Berbaum ML, Laser E, Baum J. Adjunctive self-hypnotic relaxation for outpatient medical procedures: a prospective randomized trial with women undergoing large core breast biopsy. Pain. 2006 Dec 15;126(1-3):155-64. doi: 10.1016/j.pain.2006.06.035. Epub 2006 Sep 7.
citation: Lang EV, Berbaum KS, Pauker SG, Faintuch S, Salazar GM, Lutgendorf S, Laser E, Logan H, Spiegel D. Beneficial effects of hypnosis and adverse effects of empathic attention during percutaneous tumor treatment: when being nice does not suffice. J Vasc Interv Radiol. 2008 Jun;19(6):897-905. doi: 10.1016/j.jvir.2008.01.027. Epub 2008 Mar 17.
citation: Lang EV, Tan G, Amihai I, Jensen MP. Analyzing acute procedural pain in clinical trials. Pain. 2014 Jul;155(7):1365-1373. doi: 10.1016/j.pain.2014.04.013. Epub 2014 Apr 13.