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The efficacy of Virtual Reality in Burn Care


- candidate number24423
- NTR NumberNTR5858
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-mei-2016
- Secondary IDsNL54030.099.15 RTPO Leeuwarden
- Public TitleThe efficacy of Virtual Reality in Burn Care
- Scientific TitlePsychological variables associated with the effect of VR during wound care
- ACRONYM
- hypothesisVR turned out to be promising as adjunct non-pharmacological intervention during wound dressing changes. Because the evidence for VR as pain relief is limited, more high-quality studies are needed to investigate the effect of VR on procedural pain. This study focuses on both the effectiveness and efficacy of VR.
- Healt Condition(s) or Problem(s) studiedVirtual Reality, Pain relief, Wound care , Psychologic factors
- Inclusion criteria- Age 8 years and older
- Expected admission time for at least 4 days
- Informed consent
- Mentally competent
- Dutch speaking and reading
- Permission of nurse,
- if in doubt, consultation doctor, clinical psychologist, psychiatrist and/or principal investigator
- Ability to use VR
- Exclusion criteria- Physical impairments (facial burns)
- Need for intensive care / severe comorbidity
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2016
- planned closingdate1-jul-2018
- Target number of participants128
- InterventionsInteractive Virtual Reality computerbased distraction through 3D Head Mounted Display
- Primary outcomeVR is effective in reducing pain, when there are both statistically and clinically significant differences between the VAS-scores of overall pain during care as usual with VR and care as usual.
- Secondary outcome- The satisfaction with the use of VR is meaningful when the VAS-score of satisfaction with care as usual with VR is not statistically and clinically significantly lower than the VAS-score of satisfaction with care as usual.
- The identification of independent variables associated with the expected statistically and clinically significant differences in pain and satisfaction, between care as usual with VR and care as usual.
- The number of milligrams sedation and/or analgesics used during care as usual with VR compared to care as usual.
- The number of patients reporting side-effects (like nausea) as a consequence of the use of VR. If patients using VR report significant more side effects than patients not using VR (care as usual), we have to investigate the reason of these (game choice / equipment, other).
- The description of the user friendliness of the VR-equipment with patients and medical professionals.
- Timepoints- VAS-score pain
- VAS-score satisfaction
- Question to presence of side-effects
- Question to user-friendliness of VR-equipment
- Questionnaires (ZBV, BSPAS, BDI/CDI, CERQ)
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. K.F. Lamberts
- CONTACT for SCIENTIFIC QUERIESDr. K.F. Lamberts
- Sponsor/Initiator Martini Hospital Groningen
- Funding
(Source(s) of Monetary or Material Support)
Vriendenloterij
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD31-mei-2016 - 1-jul-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl