Tooth Extraction Status NosNCT03197311
A Mobile Application for Post-op Analgesic Consumption
A study testing Mobile app in people with Tooth Extraction Status Nos and Post Operative Pain, run by Boston University at 1 site in United States.
Trial summary
Surgical extraction of third molars is one of the most common outpatient procedures performed by oral surgeons. The prescription of postoperative narcotic and NSAID analgesics is the standard of care practice to relieve symptoms of pain, swelling, and trismus after these procedures. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Tooth Extraction Status Nos, Post Operative Pain, Patient Satisfaction
- What is being tested?
- Mobile app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2019to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients between the age of 18-40 years
- Patients who require two mandibular third molars extracted
- Patients with a smartphone
Who cannot join
- Patients taking any recreational drugs and medications for chronic pain
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University Medical Campus
Boston, Massachusetts, 02118
About this study
Official title: A Mobile Application to Monitor Patient's Analgesic Consumption After Minor Oral Surgery.
Surgical extraction of third molars is one of the most common outpatient procedures performed by oral surgeons. The prescription of postoperative narcotic and NSAID analgesics is the standard of care practice to relieve symptoms of pain, swelling, and trismus after these procedures. The majority of these patients do not return for follow up unless they experience a problem. There is limited data on whether the patients use the narcotics as directed and what is their practice of disposal of the remaining medications that were not consumed.
In this research the effectiveness of postop analgesic consumption, analgesic disposal practice, pain control, and patient satisfaction will be compared between patients who are randomized to the intervention group who will use a developed mobile application and a control group who will not use the mobile app.
Read the detailed description
A pilot randomized clinical trial will be conducted to determine if use of a mobile application improves adherence to narcotic analgesic use and their disposal and patient satisfaction post-surgical extraction of third molars in an outpatient setting. Eligible consented subjects will be randomized into either the mobile app group or the control group. Both groups will receive standard of care which includes prescription of postoperative narcotic and NSAID analgesics and usual postoperative instructions.For the mobile group, the Medable Axon Software developed by Stanford University will be used to customize a mobile application that will be used one week post surgery to monitor postoperative analgesic consumption and disposal practices, pain control, and patient satisfaction, In the control group, case report forms will be used to gather data from the electronic medical records and a telephone survey will be done one week post surgery to obtain data on patient satisfaction. A total of 20 consecutive eligible patients will be enrolled in this pilot trial..
- Conditions
- Tooth Extraction Status Nos, Post Operative Pain, Patient Satisfaction, Narcotic Use, Mobile App
- Being tested
- Mobile app
- Keywords
- Oral surgery, Medication adherence
- Medical subject headings
- Pain, Postoperative, Patient Satisfaction, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile appOther
A customized mobile application will be developed and downloaded to subjects; smartphones to monitor postoperative analgesic consumption, and disposal; pain control and patient satisfaction. The mobile app will provide notifications for medications and select education links on the prescribed analgesics. Subjects will receive reminders to take medications as directed. Subjects will be able to monitor and report their pain during the first week after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Mobile app group | Experimental | In addition to receiving standard of care which includes prescription of postoperative narcotic and NSAID analgesics and usual postoperative instructions a customized mobile app will be downloaded to the participant's smartphone to application to monitor postoperative analgesic consumption, disposal and pain control and patient satisfaction for one week after surgery. Receives: Other: Mobile app |
| Control group | No intervention | The control group will receive the standard of care which includes prescription of postoperative narcotic and NSAID analgesics and usual postoperative instructions and a case report form will be used to gather data from the medical record and from a post op telephone survey a week after surgery.. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of quantity of postop analgesic (narcotic and non narcotic) medications used.
Each patient will be given 18-24 tablets the prescription: 1. Acetaminophen with 5mg oxycodone 2. Acetaminophen with 5mg hydrocodone 3. Acetaminophen with 30 mg codine and asked to report each time they take a tablet via the app in the experimental group while the control group will answer the question how many tablets do you have remaining as part of the post survey at the end of 1 week.
Measured: At the end of 7 days
Assessment of change in Postoperative pain control
The Short Form McGill Pain Questionnaire (SF-MPQ) will be used to assess post-op pain control. It consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors. Lower scores are associated with less pain..
Measured: Daily for 7 days post-op (experimental group) and At the end of 7 days (control group)
Secondary outcomes (2)
Satisfaction with the education received regarding the prescribed medications.
Assessment of patient satisfaction using a survey. For the subjects in the experimental group, they will be asked to complete a emoticon survey on the app which would correspond to the following descriptions: Excellent=4, good=3, average=2, poor=1.The subjects in the control group will be asked the same question as part of the post satisfaction survey without the emoticons as a sentence question. A lower score indicates low satisfaction.
Measured: Daily for 7 days post-op (experimental group) and At the end of 7 days (control group)
Use of the analgesic and post-op care education links on the mobile app.
Educational links will be available to view as part of the app and usage will be monitored by website traffic. Higher numbers would indicate greater usage of educational links.
Measured: Daily for 7 days post-op (experimental group) and At the end of 7 days (control group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study startOct 2019 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Why it stopped: Unable to obtain funding for this research.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth Extraction Status NosStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Radhika Chigurupati, DMD, MS, Study director, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03197311
- Sponsor's protocol ID
- H-36258
- Status last verified
- Oct 2019
- First submitted
- 21 Jun 2017
- Last updated
- 8 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile Application to Monitor Patient's Analgesic Consumption After Minor Oral Surgery.
- ClinicalTrials.gov ID
- NCT03197311
- Acronym / sponsor ID
- H-36258
- Conditions
- Tooth Extraction Status Nos, Post Operative Pain, Patient Satisfaction, Narcotic Use, Mobile App
- Keywords
- Oral surgery, Medication adherence
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to obtain funding for this research.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- Oct 2019 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 23 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Surgical extraction of third molars is one of the most common outpatient procedures performed by oral surgeons. The prescription of postoperative narcotic and NSAID analgesics is the standard of care practice to relieve symptoms of pain, swelling, and trismus after these procedures. The majority of these patients do not return for follow up unless they experience a problem. There is limited data on whether the patients use the narcotics as directed and what is their practice of disposal of the remaining medications that were not consumed.
In this research the effectiveness of postop analgesic consumption, analgesic disposal practice, pain control, and patient satisfaction will be compared between patients who are randomized to the intervention group who will use a developed mobile application and a control group who will not use the mobile app.
Detailed description
A pilot randomized clinical trial will be conducted to determine if use of a mobile application improves adherence to narcotic analgesic use and their disposal and patient satisfaction post-surgical extraction of third molars in an outpatient setting. Eligible consented subjects will be randomized into either the mobile app group or the control group. Both groups will receive standard of care which includes prescription of postoperative narcotic and NSAID analgesics and usual postoperative instructions.For the mobile group, the Medable Axon Software developed by Stanford University will be used to customize a mobile application that will be used one week post surgery to monitor postoperative analgesic consumption and disposal practices, pain control, and patient satisfaction, In the control group, case report forms will be used to gather data from the electronic medical records and a telephone survey will be done one week post surgery to obtain data on patient satisfaction. A total of 20 consecutive eligible patients will be enrolled in this pilot trial..
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile app group | Experimental | Other: Mobile appIn addition to receiving standard of care which includes prescription of postoperative narcotic and NSAID analgesics and usual postoperative instructions a customized mobile app will be downloaded to the participant's smartphone to application to monitor postoperative analgesic consumption, disposal and pain control and patient satisfaction for one week after surgery. |
| Control group | No intervention | –The control group will receive the standard of care which includes prescription of postoperative narcotic and NSAID analgesics and usual postoperative instructions and a case report form will be used to gather data from the medical record and from a post op telephone survey a week after surgery.. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients between the age of 18-40 years
- Patients who require two mandibular third molars extracted
- Patients with a smartphone
Key exclusion criteria (1 listed)
- Patients taking any recreational drugs and medications for chronic pain
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 |
|---|---|---|
| Mobile appA customized mobile application will be developed and downloaded to subjects; smartphones to monitor postoperative analgesic consumption, and disposal; pain control and patient satisfaction. The mobile app will provide notifications for medications and select education links on the prescribed analgesics. Subjects will receive reminders to take medications as directed. Subjects will be able to monitor and report their pain during the first week after surgery. | Other | Mobile app group |
Primary outcome
Assessment of quantity of postop analgesic (narcotic and non narcotic) medications used.
Time frame: At the end of 7 days
Each patient will be given 18-24 tablets the prescription: 1. Acetaminophen with 5mg oxycodone 2. Acetaminophen with 5mg hydrocodone 3. Acetaminophen with 30 mg codine and asked to report each time they take a tablet via the app in the experimental group while the control group will answer the question how many tablets do you have remaining as part of the post survey at the end of 1 week.
Assessment of change in Postoperative pain control
Time frame: Daily for 7 days post-op (experimental group) and At the end of 7 days (control group)
The Short Form McGill Pain Questionnaire (SF-MPQ) will be used to assess post-op pain control. It consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors. Lower scores are associated with less pain..
2 secondary outcomes
Satisfaction with the education received regarding the prescribed medications.
Time frame: Daily for 7 days post-op (experimental group) and At the end of 7 days (control group)
Use of the analgesic and post-op care education links on the mobile app.
Time frame: Daily for 7 days post-op (experimental group) and At the end of 7 days (control group)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
- 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.
Radhika Chigurupati, DMD, MS study director
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile app in people with Tooth Extraction Status Nos and Post Operative Pain, run by Boston University at 1 site 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 3 inclusion and 1 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: withdrawn, as of the sponsor's last update on 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Assessment of quantity of postop analgesic (narcotic and non narcotic) medications used. (time frame: At the end of 7 days). The study lists 2 primary outcomes in all. 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 8 Oct 2019.