Virtual Pain Care Trial

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status: Invitation-only

Conditions: Wound; Wound and Injuries; Pain

Treatments: Device: Virtual Reality ('VRelax' VR system)

Study type: Interventional

Funder types: Other

Identifiers

NCT05772468

NL82360.029.22

Details and patient eligibility

About

The main objective of this study is to evaluate the effect on pain of Virtual Reality Therapy as add-on therapy during wound care procedures in adults.

Full description

After inclusion and completion of the informed consent form, patients are randomly allocated to the intervention group or control group in a 1:1 ratio. Randomization will not be blinded since both the provider and patient know if the patient will be wearing the VR system during wound care or not wearing the VR system.

Patients are randomly assigned to one of two groups:

Group 1 - Intervention group 1, Virtual Reality Therapy Group 2 - Control group, care as usual

Enrollment: 32 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Individuals aged 18 or older with wounds receiving wound care
• 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 understand Dutch language at primary school level
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Virtual Reality Therapy (Intervention group 1)

Experimental group

Description:

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.

Treatment:

Device: Virtual Reality ('VRelax' VR system)

Care as usual (control group/group 2)

No Intervention group

Description:

The control group (group 2), also known as the care as usual group, receives the standard procedure during wound care without 'VRelax' VR system.