Nonpharmacologic Reduction of Periprocedural Pain and Anxiety in Dentistry

NCT05194449 | Withdrawn DMC

• 1 other identifier: R44AT009517
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Anxiety; Dental Pain; Root Work

Keywords

Nonpharmacologic analgesia; Medical app; Relaxation; Hypnosis

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Adverse events

  Up to 180 minutes

• Chair Time

  Up to 180 minutes

• Staff Time

  Up to 180 minutes

• Patient Satisfaction

  10 minutes

• Staff Satisfaction

  10 minutes

Study Arms (2)

Comfort Talk® App (Cft) Group

EXPERIMENTAL

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

Other: Comfort Talk® App

Placebo Group

PLACEBO COMPARATOR

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

Other: Placebo App

Interventions

Comfort Talk® App OTHER

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.

Also known as: Self-hypnotic relaxation app, Test app

Comfort Talk® App (Cft) Group

Placebo App OTHER

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.

Also known as: White noise app

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Known acute psychiatric disorder, such as multiple personalities which will be assessed on the medical history form
• Implanted cardiac medical device

Sponsors & Collaborators

• Hypnalgesics, LLC: lead
• Cambridge Health Alliance: collaborator

Related Publications (5)

• 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.

  PMID: 33724898 BACKGROUND

• 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.

  PMID: 10801169 BACKGROUND

• 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.

  PMID: 16959427 BACKGROUND

• 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.

  PMID: 18503905 BACKGROUND

• 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.

  PMID: 24731852 BACKGROUND

MeSH Terms

Conditions

Toothache

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Evira V Lang, MD

  Hypnalgesics, LLC d/b/a Comfort Talk®

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 18, 2022
• Study Start: June 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: March 7, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share