Dental AnxietyNCT03328208
Nonpharmacologic Reduction of Periprocedural Distress and Drug Use
A study testing Comfort Talk® app and White Noise app in people with Dental Anxiety and Dental Pain, run by Hypnalgesics, LLC at 2 sites in United States.
Trial summary
Objectives of this Phase I pilot trial are to provide data towards assessing and facilitating feasibility of a larger scale Phase II trial in which the effects of a calmative Comfort Talk® app can be unequivocally evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Anxiety, Dental Pain, Drug Use
- What is being tested?
- Comfort Talk® app and White Noise app
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Nov 2017to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled to undergo a dental procedure at the Craniofacial Pain Center
- 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 or smart phone and have access to a smart tablet, smart phone at home, or computer-based app download
- Willing and able to give informed consent
Who cannot join
- Known acute psychiatric disorder, such as multiple personalities which will be assessed on the medical history form
- Not meeting inclusion criteria
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Tufts University School of Dental Medicine
Boston, Massachusetts, 02111
Hypnalgesics, LLC
Brookline, Massachusetts, 02446
About this study
Official title: Nonpharmacologic Reduction of Periprocedural Pain, Anxiety, and Prescription Drug Use
Objectives of this Phase I pilot trial are to provide data towards assessing and facilitating feasibility of a larger scale Phase II trial in which the effects of a calmative Comfort Talk® app can be unequivocally evaluated.
Towards this goal we will pursue following outcome parameters for
Read more
Phase I: Feasibility/acceptability assessment:
Primary outcome parameter:
- ability to obtain complete on-site data sets from at least 90% of patients enrolled (with at least 40% from patients in the app group and at least 40% from patients in the control group).
Secondary outcome parameters:
- ability to enroll 60 patients by day 150 after initiation of recruitment in the clinic (=day 1)
- obtain 38 packages of filled out diary cards (at least 16 from patients in the app group and at least 16 from patients in the control group)
- 90% of patients in app group listen to app ≥5 min
Phase II preparation primary outcome parameter
- anxiety at the end of the waiting room time
Secondary outcome parameters
- pain the end of the waiting room time
- anxiety during treatment
- pain during treatment
- anxiety during 1 week after treatment
- pain during 1 week after treatment
- use of units of sedatives and analgesics during 1 week after treatment (assessed by prescription at end of the visit)
- patient satisfaction
Read the detailed description
The design is a single-blind, placebo controlled clinical trial to test the feasibility of the trial design assessing the ability of a Comfort Talk® app to nonpharmacologically reduce anxiety, pain, and periprocedural drug use in individuals 18 years of age and older undergoing outpatient treatment in the Craniofacial Pain Center of the Tufts School of Dental Medicine.
The trial is a single-site pilot trial to assist in sample size estimation in a pivotal trial to test the hypothesis that listening to a Comfort Talk® app with calmative content reduces pain, anxiety, and post-procedural medication use.
Eligible patients at the Craniofacial Pain Center at the Tufts School of Dental Medicine (TUSDM) will be randomized to listen to a tablet containing a calmative Comfort Talk® app or app with white noise on an intent-to-treat basis. Their anxiety and pain measures will be recorded on validated 0-10 scales and before listening, at the end of the waiting room period, and every 10 minutes while on the dental chair.
All patients will be given a packet with diary cards to record their levels of anxiety, pain, and drug use daily for 7 days after their visit and asked to send those back. Subjects will be mailed a $25 check upon returning their diaries.
Patients randomized to the Comfort Talk® app will receive a download coupon for the app before leaving TUSDM, those randomized to the control condition (white noise) will receive a download coupon after they send in their diary cards.
Interventions and Duration
Approximately 1 hour and 15 minutes (Up to 30 minutes more than the scheduled standard of care visit, which will typically last up to 45 minutes):
Patient will be asked to come in ½ hour early before an already scheduled appointment. They will be taken to a private area, report their demographics, and if eligible consented and fill out a NIDA Quick Screen.
The participant will then be verbally asked to indicate his/her pain and anxiety levels on validated 0-10 scales. The research assistant will then hand the participant a tablet containing, depending on the group attribution, either the app (App Group) or white noise (Control Group) and will be shown how to operate the tablet.
Participant will then return to the clinic waiting area with the tablet and wait for their regularly scheduled appointment. The patient will be at liberty to when and for how long to listen. At the end of the waiting room period the participant will be queried again for their levels of pain and anxiety.
After the participant enters the treatment room, he or she will be able to continue to listen to the app or white noise on the tablet. The research assistant will ask the participant every 10 min to indicate their pain and anxiety levels. The research assistant will note the duration of chair time, the amount of lidocaine given, if any or which other medications were given during the appointment, and whether the dental practitioner prescribed opioid, prescription or non-prescription drugs at the end of the visit.
Before leaving home, the participant will be asked to fill out a satisfaction survey based on a modified Press Ganey Template. The participant will then receive a diary card on which to note pain, average and maximal pain as well its location, use of non-prescription, prescription, and opiate drugs, use of the app, and be provided pre-stamped envelopes. Patients will be asked to complete the diary daily before bedtime for 7 days.
- Conditions
- Dental Anxiety, Dental Pain, Drug Use, Opioid Use
- Being tested
- Comfort Talk® app, White Noise app
- Keywords
- Nonpharmacologic analgesia, Medical app, Relaxation
- Medical subject headings
- Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comfort Talk® appOther
Also called Relaxation app
Test app
White Noise appOther
Also called Control app
White Noise app built to mimic appearance of Comfort Talk® test app
| Study group | Role | What they receive |
|---|---|---|
| Comfort Talk® App Group | Experimental | 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. Receives: Other: Comfort Talk® app |
| White Noise Group | Active comparator | 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. Receives: Other: White Noise app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Complete On-Site Data Sets
Feasibility defined as the ability to obtain complete on-site data sets from at least 90% of participants enrolled (with at least 40% from patients in the app group and at least 40% from patients in the control group).
Measured: Duration of outpatient clinic visit (up to 2 hrs)
Secondary outcomes (2)
Number of Days to Enroll 60 Participants
Feasibility measure defined as the ability to enroll 60 participants by day 150 after initiation of recruitment in the clinic (=day 1). Outcome measure are numbers of office days from the start of enrollment
Measured: Up to 150 days
Number of Participants Returning Diary Card Packages
Follow-up feasibility defined as obtaining 38 packages of filled out diary cards (at least 16 from patients in the app group and at least 16 from patients in the control group)
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start22 Nov 2017
- Primary completion30 Oct 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-blind placebo-controlled trial comparing a Comfort Talk® calmative app (App Group) with a white noise app (Control Group).
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hypnalgesics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tufts University
- Responsible party
- Sponsor
- Investigators
- Elvira V Lang, MD, PhD, Principal investigator, Hypnalgesics, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03328208
- Sponsor's protocol ID
- R43AT009517
- Status last verified
- Nov 2021
- First submitted
- 21 Oct 2017
- Last updated
- 30 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nonpharmacologic Reduction of Periprocedural Pain, Anxiety, and Prescription Drug Use
- ClinicalTrials.gov ID
- NCT03328208
- Acronym / sponsor ID
- R43AT009517
- Conditions
- Dental Anxiety, Dental Pain, Drug Use, Opioid Use
- Keywords
- Nonpharmacologic analgesia, Medical app, Relaxation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Hypnalgesics, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Tufts University
- Study start
- 22 Nov 2017 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 1 Nov 2017 (actual)
- Results
- Posted 4 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives of this Phase I pilot trial are to provide data towards assessing and facilitating feasibility of a larger scale Phase II trial in which the effects of a calmative Comfort Talk® app can be unequivocally evaluated.
Towards this goal we will pursue following outcome parameters for
Phase I: Feasibility/acceptability assessment:
Primary outcome parameter:
- ability to obtain complete on-site data sets from at least 90% of patients enrolled (with at least 40% from patients in the app group and at least 40% from patients in the control group).
Secondary outcome parameters:
- ability to enroll 60 patients by day 150 after initiation of recruitment in the clinic (=day 1)
- obtain 38 packages of filled out diary cards (at least 16 from patients in the app group and at least 16 from patients in the control group)
- 90% of patients in app group listen to app ≥5 min
Phase II preparation primary outcome parameter
- anxiety at the end of the waiting room time
Secondary outcome parameters
- pain the end of the waiting room time
- anxiety during treatment
- pain during treatment
- anxiety during 1 week after treatment
- pain during 1 week after treatment
- use of units of sedatives and analgesics during 1 week after treatment (assessed by prescription at end of the visit)
- patient satisfaction
Detailed description
The design is a single-blind, placebo controlled clinical trial to test the feasibility of the trial design assessing the ability of a Comfort Talk® app to nonpharmacologically reduce anxiety, pain, and periprocedural drug use in individuals 18 years of age and older undergoing outpatient treatment in the Craniofacial Pain Center of the Tufts School of Dental Medicine.
The trial is a single-site pilot trial to assist in sample size estimation in a pivotal trial to test the hypothesis that listening to a Comfort Talk® app with calmative content reduces pain, anxiety, and post-procedural medication use.
Eligible patients at the Craniofacial Pain Center at the Tufts School of Dental Medicine (TUSDM) will be randomized to listen to a tablet containing a calmative Comfort Talk® app or app with white noise on an intent-to-treat basis. Their anxiety and pain measures will be recorded on validated 0-10 scales and before listening, at the end of the waiting room period, and every 10 minutes while on the dental chair.
All patients will be given a packet with diary cards to record their levels of anxiety, pain, and drug use daily for 7 days after their visit and asked to send those back. Subjects will be mailed a $25 check upon returning their diaries.
Patients randomized to the Comfort Talk® app will receive a download coupon for the app before leaving TUSDM, those randomized to the control condition (white noise) will receive a download coupon after they send in their diary cards.
Interventions and Duration
Approximately 1 hour and 15 minutes (Up to 30 minutes more than the scheduled standard of care visit, which will typically last up to 45 minutes):
Patient will be asked to come in ½ hour early before an already scheduled appointment. They will be taken to a private area, report their demographics, and if eligible consented and fill out a NIDA Quick Screen.
The participant will then be verbally asked to indicate his/her pain and anxiety levels on validated 0-10 scales. The research assistant will then hand the participant a tablet containing, depending on the group attribution, either the app (App Group) or white noise (Control Group) and will be shown how to operate the tablet.
Participant will then return to the clinic waiting area with the tablet and wait for their regularly scheduled appointment. The patient will be at liberty to when and for how long to listen. At the end of the waiting room period the participant will be queried again for their levels of pain and anxiety.
After the participant enters the treatment room, he or she will be able to continue to listen to the app or white noise on the tablet. The research assistant will ask the participant every 10 min to indicate their pain and anxiety levels. The research assistant will note the duration of chair time, the amount of lidocaine given, if any or which other medications were given during the appointment, and whether the dental practitioner prescribed opioid, prescription or non-prescription drugs at the end of the visit.
Before leaving home, the participant will be asked to fill out a satisfaction survey based on a modified Press Ganey Template. The participant will then receive a diary card on which to note pain, average and maximal pain as well its location, use of non-prescription, prescription, and opiate drugs, use of the app, and be provided pre-stamped envelopes. Patients will be asked to complete the diary daily before bedtime for 7 days.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a single-blind placebo-controlled trial comparing a Comfort Talk® calmative app (App Group) with a white noise app (Control Group).
| Arm | Type | Receives |
|---|---|---|
| Comfort Talk® App Group | Experimental | Other: Comfort Talk® appPatients 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. |
| White Noise Group | Active comparator | Other: White Noise appPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Scheduled to undergo a dental procedure at the Craniofacial Pain Center
- 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 or smart phone and have access to a smart tablet, smart phone at home, or computer-based app download
- Willing and able to give informed consent
Key exclusion criteria (2 listed)
- Known acute psychiatric disorder, such as multiple personalities which will be assessed on the medical history form
- Not meeting inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comfort Talk® appAlso: Relaxation appTest app | Other | Comfort Talk® App Group |
| White Noise appAlso: Control appWhite Noise app built to mimic appearance of Comfort Talk® test app | Other | White Noise Group |
Primary outcome
Number of Participants With Complete On-Site Data Sets
Time frame: Duration of outpatient clinic visit (up to 2 hrs)
Feasibility defined as the ability to obtain complete on-site data sets from at least 90% of participants enrolled (with at least 40% from patients in the app group and at least 40% from patients in the control group).
2 secondary outcomes
Number of Days to Enroll 60 Participants
Time frame: Up to 150 days
Number of Participants Returning Diary Card Packages
Time frame: Up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elvira V Lang, MD, PhD principal investigator
Hypnalgesics, LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comfort Talk® app and White Noise app in people with Dental Anxiety and Dental Pain, run by Hypnalgesics, LLC at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Complete On-Site Data Sets (time frame: Duration of outpatient clinic visit (up to 2 hrs)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2021.