Ignite Creation Date:
2024-05-06 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 2:22 PM
Study NCT ID:
NCT05194449
Status:
WITHDRAWN
Last Update Posted:
2023-03-07
First Post:
2022-01-04
Brief Title:
Nonpharmacologic Reduction of Periprocedural Pain and Anxiety in Dentistry
Sponsor:
Hypnalgesics LLC
Organization:
Hypnalgesics LLC
Study Overview
Official Title:
Nonpharmacologic Reduction of Periprocedural Pain Anxiety and Prescription Drug Use Phase II
Status:
WITHDRAWN
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Never started since the study was not funded
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 alternativeadjunct 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 anxietyno pain at all 10-worst anxietypain 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 patients 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
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 anxietyno pain at all 10-worst anxietypain 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 patients 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 alternativeadjunct 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 HealthNCCIH 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 12000 annual visits and ethnicallyracially 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 interprofessionalcross-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 patients 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 ECGheart 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 patients 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
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 12000 annual visits and ethnicallyracially 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 interprofessionalcross-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 patients 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 ECGheart 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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None