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Proof of Concept Pain App


- candidate number28009
- NTR NumberNTR6746
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-okt-2017
- Secondary IDsOLVG WO 17.103 
- Public TitleProof of Concept Pain App
- Scientific TitleProof of Concept Pain App
- ACRONYM
- hypothesis1)What are the important design-, usability issues and recommendations when attempting to improve a prototype smartphone application for patient-reported pain outcomes?
2) What is the difference in pain intensity self reported by the patient and the reported NRS by nurses in HER?
- Healt Condition(s) or Problem(s) studiedPost-operative pain, Pain app
- Inclusion criteriaAll patients undergoing surgery are eligible for participation in this proof of concept. A patient must meet all of the following criteria: age 18 years or older, undergoing surgery and in possession of a smartphone and willing to participate in this proof of concept study.
- Exclusion criteriaA patient who meets any of the following criteria will be excluded from participation in this study: age 0-18years, not able to use computer or smartphone, not able to read or understand Dutch.
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 19-sep-2017
- planned closingdate19-nov-2017
- Target number of participants50
- InterventionsPatients willing to participate in this study receive a smartphone application for self registration of postopoperative pain during their admission in hospital
- Primary outcome1) Collecting feedback from patients, healthcare professionals and ICT technicians in order to improve the current prototype pain assessment tool, the PAIN app, and the bidirectional communication and ‘rapid response’ of ward nurses and the anaesthetic team.

2) Exploring the differences in reliability validity and the responsiveness between patient self reported pain intensity and the reported NRS by nurses in EMR
- Secondary outcome1) Overview of the development and production of the PAIN App. (‘Technical Document’)

2) Developing and testing the post operative pain management workflow
- Timepoints-start patient recruitment september 19th 2017
-end patient inclusion november 19th 2017
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMSc. B. Thiel
- CONTACT for SCIENTIFIC QUERIESMSc. B. Thiel
- Sponsor/Initiator OLVG
- Funding
(Source(s) of Monetary or Material Support)
WM de Hoop Stichting, SIDN fonds
- Publications
- Brief summaryIn this proof of concept study we will collect data of patients, healthcare professionals and ICT technician’s experiences on the usability and the validity of the application. The use of this application during the course of this study will have no clinical implications for the treatment of postoperative pain. Patients will receive care as usual provided by the ward nurses.
- Main changes (audit trail)
- RECORD13-okt-2017 - 28-okt-2017


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