Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
32 participants
INTERVENTIONAL
2023-11-07
2025-11-01
Brief Summary
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Detailed Description
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Patients are randomly assigned to one of two groups:
Group 1 - Intervention group 1, Virtual Reality Therapy Group 2 - Control group, care as usual
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Virtual Reality Therapy (Intervention group 1)
In addition to the standard wound care procedure, the Virtual Reality Therapy group (intervention group 1) will receive the VR system during the wound care. The VR system consists of Virtual Reality glasses, and a headphone. The application VRelax will be used, which will contain various videos for the patient those from to relax and be distracted. This group wears the VR system 10 minutes before the start of the wound care, until 1 minute after the wound care has ended.
Virtual Reality ('VRelax' VR system)
The intervention group 1 will be wearing the 'VRelax' Virtual Reality system during the wound care moment in addition to the standard procedure. The VR system consists of Virtual Reality glasses, and a headphone. The VRelax Application will be used.
Care as usual (control group/group 2)
The control group (group 2), also known as the care as usual group, receives the standard procedure during wound care without 'VRelax' VR system.
No interventions assigned to this group
Interventions
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Virtual Reality ('VRelax' VR system)
The intervention group 1 will be wearing the 'VRelax' Virtual Reality system during the wound care moment in addition to the standard procedure. The VR system consists of Virtual Reality glasses, and a headphone. The VRelax Application will be used.
Eligibility Criteria
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Inclusion Criteria
* Individuals who will undergo minimum of 1 to a maximum of 3 sequential complex wound care procedures
* At least 1 prior painful wound care procedure, where they have indicated a VAS ≥ 4, or patients reporting a VAS ≥ 4 before initiating the wound care procedure.
Exclusion Criteria
* Individuals not being able to read or write Dutch
* Individuals diagnosed with dementia and/or cognitive impairment
* Individuals diagnosed with epilepsy
* Individuals diagnosed with migraine
* Individuals with severe dizziness and/or nausea
* Individuals with a known history of claustrophobia
* Individuals who are unable to sign informed consent owing to mental disorder or formally stated to be incompetent to decide
* Individuals who have no feeling in the wound care area
* Individuals with physical (and/or cognitive) disabilities on the face, eye, ear, nose and neck that prevent the use of the VR headgear and/or headphones
18 Years
ALL
No
Sponsors
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
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Marlies P. Schijven
Professor doctor
Principal Investigators
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Marlies Schijven, Prof. dr.
Role: PRINCIPAL_INVESTIGATOR
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Locations
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Amsterdam University Medical Center
Amsterdam, North Holland, Netherlands
Countries
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Other Identifiers
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NL82360.029.22
Identifier Type: -
Identifier Source: org_study_id
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