Nonpharmacologic Reduction of Periprocedural Distress and Drug Use
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 |
---|---|---|
|
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
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:
|
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:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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
- 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
- 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
- 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)
- 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)
- 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
- 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
- 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)
- 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
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.- R43AT009517
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
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%
|
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
|
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%
|
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 |
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 |
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)
|
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)
|
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)
|
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)
|
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%
|
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
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 |
drevlang@comforttalk.com |
- R43AT009517