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- Klinische proef 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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02118
- Boston University Medical Campus
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Geen tussenkomst: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Assessment of quantity of postop analgesic (narcotic and non narcotic) medications used.
Tijdsspanne: 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
Tijdsspanne: 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..
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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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Satisfaction with the education received regarding the prescribed medications.
Tijdsspanne: 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.
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Radhika Chigurupati, DMD, MS, Boston University Medical Campus
Studie record data
Bestudeer belangrijke data
Studie start (Verwacht)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- H-36258
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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