Trial Outcomes & Findings for Nonpharmacologic Reduction of Periprocedural Distress and Drug Use (NCT NCT03328208)
NCT ID: NCT03328208
Last Updated: 2021-11-30
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
72 participants
Primary outcome timeframe
Duration of outpatient clinic visit (up to 2 hrs)
Results posted on
2021-11-30
Participant Flow
Participant milestones
| Measure |
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.
Comfort Talk® app: Test app
|
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.
White Noise app: White Noise app built to mimic appearance of Comfort Talk® test app
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
35
|
|
Overall Study
COMPLETED
|
37
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nonpharmacologic Reduction of Periprocedural Distress and Drug Use
Baseline characteristics by cohort
| Measure |
Comfort Talk® App Group
n=37 Participants
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
|
White Noise Group
n=35 Participants
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
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=5 Participants
|
35 participants
n=7 Participants
|
72 participants
n=5 Participants
|
|
Pain
|
3.4 units on a scale
n=5 Participants
|
2.8 units on a scale
n=7 Participants
|
3.1 units on a scale
n=5 Participants
|
|
Anxiety
|
2.6 units on a scale
n=5 Participants
|
2.5 units on a scale
n=7 Participants
|
2.6 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: Duration of outpatient clinic visit (up to 2 hrs)Population: Participants enrolled
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).
Outcome measures
| Measure |
Comfort Talk® App Group
n=37 Participants
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
|
White Noise Group
n=35 Participants
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
|
|---|---|---|
|
Number of Participants With Complete On-Site Data Sets
|
37 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: Up to 150 daysPopulation: Number of participants within the cohort of the first 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
Outcome measures
| Measure |
Comfort Talk® App Group
n=31 Participants
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
|
White Noise Group
n=29 Participants
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
|
|---|---|---|
|
Number of Days to Enroll 60 Participants
|
106 Days
|
106 Days
|
SECONDARY outcome
Timeframe: Up to 6 monthsFollow-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)
Outcome measures
| Measure |
Comfort Talk® App Group
n=37 Participants
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
|
White Noise Group
n=35 Participants
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
|
|---|---|---|
|
Number of Participants Returning Diary Card Packages
|
15 Participants
|
11 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 60 minAnxiety 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
Outcome measures
| Measure |
Comfort Talk® App Group
n=37 Participants
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
|
White Noise Group
n=35 Participants
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
|
|---|---|---|
|
Anxiety at the End of the Waiting Room Time (Change as Compared to Beginning of the Waiting Room Time)
|
-0.81 units on a scale
Interval -1.21 to -0.41
|
-0.66 units on a scale
Interval -1.16 to 0.16
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 60 minPain 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
Outcome measures
| Measure |
Comfort Talk® App Group
n=37 Participants
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
|
White Noise Group
n=35 Participants
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
|
|---|---|---|
|
Pain the End of the Waiting Room Time (Change as Compared to Beginning of the Waiting Room Time)
|
-0.76 units on a scale
Interval -1.15 to -0.37
|
-0.26 units on a scale
Interval -0.56 to -0.05
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 120 minTime 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)
Outcome measures
| Measure |
Comfort Talk® App Group
n=37 Participants
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
|
White Noise Group
n=35 Participants
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
|
|---|---|---|
|
Pain During Dental Treatment
|
2.5 units on a scale
Standard Deviation 2.0
|
2.5 units on a scale
Standard Deviation 1.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 120 minTime 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)
Outcome measures
| Measure |
Comfort Talk® App Group
n=37 Participants
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
|
White Noise Group
n=35 Participants
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
|
|---|---|---|
|
Anxiety During Dental Treatment
|
2.2 units on a scale
Standard Deviation 2.1
|
2.0 units on a scale
Standard Deviation 1.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 7 daysPopulation: Participants who returned their diary card packages
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
Outcome measures
| Measure |
Comfort Talk® App Group
n=15 Participants
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
|
White Noise Group
n=11 Participants
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
|
|---|---|---|
|
Average Maximal Anxiety During 1 Week After Dental Treatment
|
2.3 units on a scale
Standard Deviation 1.7
|
2.3 units on a scale
Standard Deviation 1.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 7 daysPopulation: Participants who returned their diary card packages
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
Outcome measures
| Measure |
Comfort Talk® App Group
n=15 Participants
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
|
White Noise Group
n=11 Participants
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
|
|---|---|---|
|
Average Maximal Pain During 1 Week After Treatment
|
2.9 units on a scale
Standard Deviation 1.4
|
3.1 units on a scale
Standard Deviation 1.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 7 daysPopulation: All enrolled participants
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)
Outcome measures
| Measure |
Comfort Talk® App Group
n=37 Participants
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
|
White Noise Group
n=35 Participants
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
|
|---|---|---|
|
Number of Participants Receiving New Prescriptions for Drugs
|
8 participants
|
5 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 hrsPatient 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)
Outcome measures
| Measure |
Comfort Talk® App Group
n=37 Participants
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
|
White Noise Group
n=35 Participants
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
|
|---|---|---|
|
Patient Satisfaction
|
4.6 units on a scale
Interval 3.5 to 5.0
|
4.6 units on a scale
Interval 3.3 to 5.0
|
Adverse Events
Comfort Talk® App Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
White Noise Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place