Nonpharmacologic Reduction of Periprocedural Distress and Drug Use
| Status: | Completed |
|---|---|
| Conditions: | Anxiety, Chronic Pain, Dental |
| Therapuetic Areas: | Dental / Maxillofacial Surgery, Musculoskeletal, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/3/2019 |
| Start Date: | November 22, 2017 |
| End Date: | December 31, 2018 |
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
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
- patient satisfaction
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
- patient satisfaction
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.
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.
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
We found this trial at
2
sites
Boston, Massachusetts 02111
Principal Investigator: Ronald Kulich, PhD
Phone: 617-636-2147
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