- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03197311
A Mobile Application for Post-op Analgesic Consumption
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Massachusetts
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Boston, Massachusetts, Förenta staterna, 02118
- Boston University Medical Campus
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Patients between the age of 18-40 years
- Patients who require two mandibular third molars extracted
- Patients with a smartphone
Exclusion Criteria:
- Patients taking any recreational drugs and medications for chronic pain
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Mobile app group
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.
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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.
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Inget ingripande: Control group
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..
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Assessment of quantity of postop analgesic (narcotic and non narcotic) medications used.
Tidsram: At the end of 7 days
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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.
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At the end of 7 days
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Assessment of change in Postoperative pain control
Tidsram: Daily for 7 days post-op (experimental group) and At the end of 7 days (control group)
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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..
|
Daily for 7 days post-op (experimental group) and At the end of 7 days (control group)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Satisfaction with the education received regarding the prescribed medications.
Tidsram: Daily for 7 days post-op (experimental group) and At the end of 7 days (control group)
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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.
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Daily for 7 days post-op (experimental group) and At the end of 7 days (control group)
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Use of the analgesic and post-op care education links on the mobile app.
Tidsram: Daily for 7 days post-op (experimental group) and At the end of 7 days (control group)
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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.
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Daily for 7 days post-op (experimental group) and At the end of 7 days (control group)
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Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Radhika Chigurupati, DMD, MS, Boston University Medical Campus
Studieavstämningsdatum
Studera stora datum
Studiestart (Förväntat)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- H-36258
Plan för individuella deltagardata (IPD)
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Läkemedels- och apparatinformation, studiedokument
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