Nonpharmacologic Reduction of Periprocedural Distress and Drug Use

Sponsor
Hypnalgesics, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT03328208
Collaborator
Tufts University (Other)
72
2
2
13.3
36
2.7

Study Details

Study Description

Brief 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.

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

Condition or Disease Intervention/Treatment Phase
  • Other: Comfort Talk® app
  • Other: White Noise app
N/A

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

Study Type:
Interventional
Actual Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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).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 (Care Provider, Investigator, Outcomes Assessor)
Masking Description:
The four tablets used in the study will be labeled A,B,C,D and will be preloaded with the app or white noise by the Hypnalgesics, LLC in randomized sequence. Personnel at TUSDM 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. At the end of their visit, patients will receive a sealed envelope which according to their number will either contain a download coupon for the app for home use or a thank you note. To maintain blinding, all patients who send their diaries back will receive a download coupon.
Primary Purpose:
Other
Official Title:
Nonpharmacologic Reduction of Periprocedural Pain, Anxiety, and Prescription Drug Use
Actual Study Start Date :
Nov 22, 2017
Actual Primary Completion Date :
Oct 30, 2018
Actual Study Completion Date :
Dec 31, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Comfort Talk® App Group

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: Comfort Talk® app
Test app
Other Names:
  • Relaxation app
  • Active Comparator: White Noise Group

    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: White Noise app
    White Noise app built to mimic appearance of Comfort Talk® test app
    Other Names:
  • Control app
  • Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Complete On-Site Data Sets [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).

    Secondary Outcome Measures

    1. Number of Days to Enroll 60 Participants [Up to 150 days]

      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

    2. Number of Participants Returning Diary Card Packages [Up to 6 months]

      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)

    Other Outcome Measures

    1. Anxiety at the End of the Waiting Room Time (Change as Compared to Beginning of the Waiting Room Time) [Up to 60 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

    2. Pain the End of the Waiting Room Time (Change as Compared to Beginning of the Waiting Room Time) [Up to 60 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

    3. Pain During Dental Treatment [Up to 120 min]

      Time course of pain as measured by self-report on a 0-10 scale with 0=no pain at all and 10=worst pain possible (average over 10 minute intervals)

    4. Anxiety During Dental Treatment [Up to 120 min]

      Time course of anxiety as measured by self-report on a 0-10 scale with 0=no anxiety at all and 10=worst anxiety possible (average over 10 minute intervals)

    5. Average Maximal Anxiety During 1 Week After Dental Treatment [7 days]

      Average maximal daily anxiety as measured daily by self-report on a 0-10 scale with 0=no anxiety at all and 10=worst anxiety possible

    6. Average Maximal Pain During 1 Week After Treatment [7 days]

      Average of maximal daily pain as measured daily by self-report on a 0-10 scale with 0=no pain at all and 10=worst pain possible

    7. Number of Participants Receiving New Prescriptions for Drugs [7 days]

      Participants receiving new prescriptions for drugs at the end of their visit for the subsequent week (alone or in combination opioids, non-opioid analgesics, anxiolytics, muscle relaxants, triptan, and/or anticonvulsants)

    8. Patient Satisfaction [Up to 3 hrs]

      Patient satisfaction on a questionnaire at the end of the outpatient clinic visit, modeled after Press Ganey and averaged over 7 domains and groups. Assessment on Likert Scales from 1 (worst)-5 (best)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 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

    Exclusion Criteria:
    • Known acute psychiatric disorder, such as multiple personalities which will be assessed on the medical history form

    • Not meeting inclusion criteria

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tufts University School of Dental Medicine Boston Massachusetts United States 02111
    2 Hypnalgesics, LLC Brookline Massachusetts United States 02446

    Sponsors and Collaborators

    • Hypnalgesics, LLC
    • Tufts University

    Investigators

    • Principal Investigator: Elvira V Lang, MD, PhD, Hypnalgesics, LLC

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Hypnalgesics, LLC
    ClinicalTrials.gov Identifier:
    NCT03328208
    Other Study ID Numbers:
    • R43AT009517
    First Posted:
    Nov 1, 2017
    Last Update Posted:
    Nov 30, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hypnalgesics, LLC
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Comfort Talk® App Group White Noise Group
    Arm/Group Description 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. Comfort Talk® app: Test 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. White Noise app: White Noise app built to mimic appearance of Comfort Talk® test app
    Period Title: Overall Study
    STARTED 37 35
    COMPLETED 37 35
    NOT COMPLETED 0 0

    Baseline Characteristics

    Arm/Group Title Comfort Talk® App Group White Noise Group Total
    Arm/Group Description 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. Comfort Talk® app: Test 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. White Noise app: White Noise app built to mimic appearance of Comfort Talk® test app Total of all reporting groups
    Overall Participants 37 35 72
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    31
    83.8%
    27
    77.1%
    58
    80.6%
    >=65 years
    6
    16.2%
    8
    22.9%
    14
    19.4%
    Sex: Female, Male (Count of Participants)
    Female
    29
    78.4%
    21
    60%
    50
    69.4%
    Male
    8
    21.6%
    14
    40%
    22
    30.6%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    0
    0%
    0
    0%
    Not Hispanic or Latino
    37
    100%
    34
    97.1%
    71
    98.6%
    Unknown or Not Reported
    0
    0%
    1
    2.9%
    1
    1.4%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    6
    16.2%
    1
    2.9%
    7
    9.7%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    2
    5.7%
    2
    2.8%
    White
    31
    83.8%
    30
    85.7%
    61
    84.7%
    More than one race
    0
    0%
    1
    2.9%
    1
    1.4%
    Unknown or Not Reported
    0
    0%
    1
    2.9%
    1
    1.4%
    Region of Enrollment (participants) [Number]
    United States
    37
    100%
    35
    100%
    72
    100%
    Pain (units on a scale) [Mean (Full Range) ]
    Mean (Full Range) [units on a scale]
    3.4
    2.8
    3.1
    Anxiety (units on a scale) [Mean (Full Range) ]
    Mean (Full Range) [units on a scale]
    2.6
    2.5
    2.6

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants With Complete On-Site Data Sets
    Description 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).
    Time Frame Duration of outpatient clinic visit (up to 2 hrs)

    Outcome Measure Data

    Analysis Population Description
    Participants enrolled
    Arm/Group Title Comfort Talk® App Group White Noise Group
    Arm/Group Description 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. Comfort Talk® app: Test 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. White Noise app: White Noise app built to mimic appearance of Comfort Talk® test app
    Measure Participants 37 35
    Count of Participants [Participants]
    37
    100%
    35
    100%
    2. Secondary Outcome
    Title Number of Days to Enroll 60 Participants
    Description 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
    Time Frame Up to 150 days

    Outcome Measure Data

    Analysis Population Description
    Number of participants within the cohort of the first 60 participants
    Arm/Group Title Comfort Talk® App Group White Noise Group
    Arm/Group Description 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. Comfort Talk® app: Test 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. White Noise app: White Noise app built to mimic appearance of Comfort Talk® test app
    Measure Participants 31 29
    Number [Days]
    106
    106
    3. Secondary Outcome
    Title Number of Participants Returning Diary Card Packages
    Description 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)
    Time Frame Up to 6 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Comfort Talk® App Group White Noise Group
    Arm/Group Description 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. Comfort Talk® app: Test 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. White Noise app: White Noise app built to mimic appearance of Comfort Talk® test app
    Measure Participants 37 35
    Count of Participants [Participants]
    15
    40.5%
    11
    31.4%
    4. Other Pre-specified Outcome
    Title Anxiety at the End of the Waiting Room Time (Change as Compared to Beginning of the Waiting Room Time)
    Description 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
    Time Frame Up to 60 min

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Comfort Talk® App Group White Noise Group
    Arm/Group Description 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. Comfort Talk® app: Test 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. White Noise app: White Noise app built to mimic appearance of Comfort Talk® test app
    Measure Participants 37 35
    Mean (95% Confidence Interval) [units on a scale]
    -0.81
    -0.66
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Comfort Talk® App Group, White Noise Group
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.05
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.724
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    5. Other Pre-specified Outcome
    Title Pain the End of the Waiting Room Time (Change as Compared to Beginning of the Waiting Room Time)
    Description 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
    Time Frame Up to 60 min

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Comfort Talk® App Group White Noise Group
    Arm/Group Description 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. Comfort Talk® app: Test 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. White Noise app: White Noise app built to mimic appearance of Comfort Talk® test app
    Measure Participants 37 35
    Mean (95% Confidence Interval) [units on a scale]
    -0.76
    -0.26
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Comfort Talk® App Group, White Noise Group
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.05
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.038
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    6. Other Pre-specified Outcome
    Title Pain During Dental Treatment
    Description Time course of pain as measured by self-report on a 0-10 scale with 0=no pain at all and 10=worst pain possible (average over 10 minute intervals)
    Time Frame Up to 120 min

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Comfort Talk® App Group White Noise Group
    Arm/Group Description 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. Comfort Talk® app: Test 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. White Noise app: White Noise app built to mimic appearance of Comfort Talk® test app
    Measure Participants 37 35
    Mean (Standard Deviation) [units on a scale]
    2.5
    (2.0)
    2.5
    (1.9)
    7. Other Pre-specified Outcome
    Title Anxiety During Dental Treatment
    Description Time course of anxiety as measured by self-report on a 0-10 scale with 0=no anxiety at all and 10=worst anxiety possible (average over 10 minute intervals)
    Time Frame Up to 120 min

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Comfort Talk® App Group White Noise Group
    Arm/Group Description 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. Comfort Talk® app: Test 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. White Noise app: White Noise app built to mimic appearance of Comfort Talk® test app
    Measure Participants 37 35
    Mean (Standard Deviation) [units on a scale]
    2.2
    (2.1)
    2.0
    (1.7)
    8. Other Pre-specified Outcome
    Title Average Maximal Anxiety During 1 Week After Dental Treatment
    Description Average maximal daily anxiety as measured daily by self-report on a 0-10 scale with 0=no anxiety at all and 10=worst anxiety possible
    Time Frame 7 days

    Outcome Measure Data

    Analysis Population Description
    Participants who returned their diary card packages
    Arm/Group Title Comfort Talk® App Group White Noise Group
    Arm/Group Description 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. Comfort Talk® app: Test 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. White Noise app: White Noise app built to mimic appearance of Comfort Talk® test app
    Measure Participants 15 11
    Mean (Standard Deviation) [units on a scale]
    2.3
    (1.7)
    2.3
    (1.9)
    9. Other Pre-specified Outcome
    Title Average Maximal Pain During 1 Week After Treatment
    Description Average of maximal daily pain as measured daily by self-report on a 0-10 scale with 0=no pain at all and 10=worst pain possible
    Time Frame 7 days

    Outcome Measure Data

    Analysis Population Description
    Participants who returned their diary card packages
    Arm/Group Title Comfort Talk® App Group White Noise Group
    Arm/Group Description 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. Comfort Talk® app: Test 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. White Noise app: White Noise app built to mimic appearance of Comfort Talk® test app
    Measure Participants 15 11
    Mean (Standard Deviation) [units on a scale]
    2.9
    (1.4)
    3.1
    (1.2)
    10. Other Pre-specified Outcome
    Title Number of Participants Receiving New Prescriptions for Drugs
    Description Participants receiving new prescriptions for drugs at the end of their visit for the subsequent week (alone or in combination opioids, non-opioid analgesics, anxiolytics, muscle relaxants, triptan, and/or anticonvulsants)
    Time Frame 7 days

    Outcome Measure Data

    Analysis Population Description
    All enrolled participants
    Arm/Group Title Comfort Talk® App Group White Noise Group
    Arm/Group Description 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. Comfort Talk® app: Test 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. White Noise app: White Noise app built to mimic appearance of Comfort Talk® test app
    Measure Participants 37 35
    Number [participants]
    8
    21.6%
    5
    14.3%
    11. Other Pre-specified Outcome
    Title Patient Satisfaction
    Description Patient satisfaction on a questionnaire at the end of the outpatient clinic visit, modeled after Press Ganey and averaged over 7 domains and groups. Assessment on Likert Scales from 1 (worst)-5 (best)
    Time Frame Up to 3 hrs

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Comfort Talk® App Group White Noise Group
    Arm/Group Description 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. Comfort Talk® app: Test 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. White Noise app: White Noise app built to mimic appearance of Comfort Talk® test app
    Measure Participants 37 35
    Mean (Full Range) [units on a scale]
    4.6
    4.6

    Adverse Events

    Time Frame 1 week
    Adverse Event Reporting Description
    Arm/Group Title Comfort Talk® App Group White Noise Group
    Arm/Group Description 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. Comfort Talk® app: Test 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. White Noise app: White Noise app built to mimic appearance of Comfort Talk® test app
    All Cause Mortality
    Comfort Talk® App Group White Noise Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/37 (0%) 0/35 (0%)
    Serious Adverse Events
    Comfort Talk® App Group White Noise Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/37 (0%) 0/35 (0%)
    Other (Not Including Serious) Adverse Events
    Comfort Talk® App Group White Noise Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/37 (0%) 0/35 (0%)

    Limitations/Caveats

    This was a feasibility study and as such was not powered to find differences in all domains.

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Elvira V. Lang, MD, CEO
    Organization Hypnalgesics, LLC
    Phone 6177349087
    Email drevlang@comforttalk.com
    Responsible Party:
    Hypnalgesics, LLC
    ClinicalTrials.gov Identifier:
    NCT03328208
    Other Study ID Numbers:
    • R43AT009517
    First Posted:
    Nov 1, 2017
    Last Update Posted:
    Nov 30, 2021
    Last Verified:
    Nov 1, 2021