Virtual Pain Care Trial
- Conditions
- WoundWound and InjuriesPain
- Interventions
- Device: Virtual Reality ('VRelax' VR system)
- Registration Number
- NCT05772468
- Brief Summary
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
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 32
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Virtual Reality Therapy (Intervention group 1) Virtual Reality ('VRelax' VR system) 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.
- Primary Outcome Measures
Name Time Method The primary outcome is the change in pain score before and after the first wound care, measured with the Visual Analogue Scale (VAS). Baseline, during the procedure, immediately after procedur The VAS is a horizontal scale from 0 to 10, with 0 indicating ''no pain'' and 10 indicating ''worst pain possible''.
- Secondary Outcome Measures
Name Time Method Mean VAS change of all wound care procedures included in the study Baseline, during the procedure, immediately after procedure The VAS is a horizontal scale from 0 to 10, with 0 indicating ''no pain'' and 10 indicating ''worst pain possible''.
Provider satisfaction Through study completion, an average of 1 year Provider satisfaction, as measured by a self-developed Dutch provider satisfaction questionnaire, focuses on satisfaction about the intervention with the VR system or headphone with audio. The questionnaires included a Visual Analogue Scale (VAS). The VAS is a horizontal scale from 0 to 10, with 0 indicating ''the worst score'' and 10 indicating ''the best score'', or with 0 indicating '''the best score'' and 10 indicating ''the worst score''.
Change from baseline pulse rate at 5 minutes after procedure Baseline, 5 minutes after procedure The pulse rate 5 minutes before intervention (intervention group)/wound care (control group), and 5 minutes after the intervention (intervention group)/wound care (control group)
Change from baseline blood oxygen level at 5 minutes after procedure Baseline, 5 minutes after procedure The blood oxygen level, measured using a pulse oximetry device, 5 minutes before intervention (intervention group)/wound care (control group), and 5 minutes after the intervention (intervention group)/wound care (control group)
Change of blood oxygen level during procedure During procedure The blood oxygen level, measured using a pulse oximetry device, every 5 minutes during procedure
Change from baseline in level of anxiety at 10 minutes after procedure Baseline, 10 minutes after procedure Level of anxiety, as measured by a Dutch translated and validated modification of the Spielberger State-Trait Inventory-6 (STAI-6) questionnaire 10 minutes before and 10 minutes after each three wound care moments.
Change from baseline systolic blood pressure and diastolic blood pressure at 5 minutes after procedure Baseline, 5 minutes after procedure The systolic blood pressure and diastolic blood pressure 5 minutes before the intervention (intervention group)/wound care (control group) and 5 minutes after the intervention (intervention group)/wound care (control group)
Change of systolic blood pressure and diastolic blood pressure during procedure During procedure The systolic blood pressure and diastolic blood pressure every 5 minutes during procedure
Change of respiratory rate during procedure During procedure The respiratory rate every 5 minutes during procedure
Change of pulse rate during procedure During procedure The pulse rate every 5 minutes during procedure
Patient satisfaction Through study completion, an average of 1 week Patient satisfaction, as measured by a self-developed Dutch provider satisfaction questionnaire, focuses on satisfaction about the intervention with the VR system or headphone with audio. The questionnaires included a Visual Analogue Scale (VAS). The VAS is a horizontal scale from 0 to 10, with 0 indicating ''the worst score'' and 10 indicating ''the best score'', or with 0 indicating '''the best score'' and 10 indicating ''the worst score''.
Change from baseline respiratory rate at 5 minutes after procedure Baseline, 5 minutes after procedure The respiratory rate 5 minutes before intervention (intervention group)/wound care (control group), and 5 minutes after the intervention (intervention group)/wound care (control group)
Trial Locations
- Locations (1)
Amsterdam University Medical Center
🇳🇱Amsterdam, Noord-Holland, Netherlands