Virtual Pain Care Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Virtual Reality ('VRelax' VR system).
- Who it may be relevant to
- Registry conditions: Wound, Wound and Injuries, Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Virtual Pain Care; the Effectiveness of Virtual Reality Therapy on Reducing Pain, and Anxiety During Complex Wound Care Procedures in Adults
Overview
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.
Detailed 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
Interventions
- Device 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.
Primary outcome measures
- The primary outcome is the change in pain score before and after the first wound care, measured with the Visual Analogue Scale (VAS). [Time frame: Baseline, during the procedure, immediately after procedur]
Secondary outcome measures (12)
- Mean VAS change of all wound care procedures included in the study [Time frame: Baseline, during the procedure, immediately after procedure]
- Change from baseline in level of anxiety at 10 minutes after procedure [Time frame: Baseline, 10 minutes after procedure]
- Patient satisfaction [Time frame: Through study completion, an average of 1 week]
- Provider satisfaction [Time frame: Through study completion, an average of 1 year]
- Change from baseline systolic blood pressure and diastolic blood pressure at 5 minutes after procedure [Time frame: Baseline, 5 minutes after procedure]
- Change of systolic blood pressure and diastolic blood pressure during procedure [Time frame: During procedure]
- Change from baseline blood oxygen level at 5 minutes after procedure [Time frame: Baseline, 5 minutes after procedure]
- Change of blood oxygen level during procedure [Time frame: During procedure]
- Change from baseline pulse rate at 5 minutes after procedure [Time frame: Baseline, 5 minutes after procedure]
- Change of pulse rate during procedure [Time frame: During procedure]
- Change from baseline respiratory rate at 5 minutes after procedure [Time frame: Baseline, 5 minutes after procedure]
- Change of respiratory rate during procedure [Time frame: During procedure]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Netherlands · 1 center
- Amsterdam University Medical Center — Amsterdam
Identifiers
NCT: NCT05772468 · NL82360.029.22