WoundNCT05772468
Virtual Pain Care Trial
A study testing Virtual Reality ('VRelax' VR system) in people with Wound and Wound and Injuries, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound, Wound and Injuries, Pain
- What is being tested?
- Virtual Reality ('VRelax' VR system)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Nov 2023to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Amsterdam University Medical Center
Amsterdam, North Holland, 1105AZ
About this study
Official title: Virtual Pain Care; the Effectiveness of Virtual Reality Therapy on Reducing Pain, and Anxiety During Complex Wound Care Procedures in Adults
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.
Read the 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
- Conditions
- Wound, Wound and Injuries, Pain
- Being tested
- Virtual Reality ('VRelax' VR system)
- Keywords
- Wound Care, Virtual Reality, Pain management
- Medical subject headings
- Wounds and Injuries, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality ('VRelax' VR system)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Therapy (Intervention group 1) | Experimental | 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. Receives: Device: Virtual Reality ('VRelax' VR system) |
| Care as usual (control group/group 2) | No intervention | The control group (group 2), also known as the care as usual group, receives the standard procedure during wound care without 'VRelax' VR system. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the change in pain score before and after the first wound care, measured with the Visual Analogue Scale (VAS).
The VAS is a horizontal scale from 0 to 10, with 0 indicating ''no pain'' and 10 indicating ''worst pain possible''.
Measured: Baseline, during the procedure, immediately after procedur
Secondary outcomes (12)
Mean VAS change of all wound care procedures included in the study
The VAS is a horizontal scale from 0 to 10, with 0 indicating ''no pain'' and 10 indicating ''worst pain possible''.
Measured: Baseline, during the procedure, immediately after procedure
Change from baseline in level of anxiety at 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.
Measured: Baseline, 10 minutes after procedure
Patient satisfaction
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''.
Measured: Through study completion, an average of 1 week
Provider satisfaction
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''.
Measured: Through study completion, an average of 1 year
Change from baseline systolic blood pressure and diastolic blood pressure at 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)
Measured: Baseline, 5 minutes after procedure
Change of systolic blood pressure and diastolic blood pressure during procedure
The systolic blood pressure and diastolic blood pressure every 5 minutes during procedure
Measured: During procedure
Change from baseline blood oxygen level at 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)
Measured: Baseline, 5 minutes after procedure
Change of blood oxygen level during procedure
The blood oxygen level, measured using a pulse oximetry device, every 5 minutes during procedure
Measured: During procedure
Change from baseline pulse rate at 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)
Measured: Baseline, 5 minutes after procedure
Change of pulse rate during procedure
The pulse rate every 5 minutes during procedure
Measured: During procedure
Change from baseline respiratory rate at 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)
Measured: Baseline, 5 minutes after procedure
Change of respiratory rate during procedure
The respiratory rate every 5 minutes during procedure
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start7 Nov 2023
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marlies P. Schijven, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Marlies Schijven, Prof. dr., Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05772468
- Sponsor's protocol ID
- NL82360.029.22
- Status last verified
- Jan 2025
- First submitted
- 22 Feb 2023
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Pain Care; the Effectiveness of Virtual Reality Therapy on Reducing Pain, and Anxiety During Complex Wound Care Procedures in Adults
- ClinicalTrials.gov ID
- NCT05772468
- Acronym / sponsor ID
- NL82360.029.22
- Conditions
- Wound, Wound and Injuries, Pain
- Keywords
- Wound Care, Virtual Reality, Pain management
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Therapy (Intervention group 1) | Experimental | Device: 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. |
| Care as usual (control group/group 2) | No intervention | –The control group (group 2), also known as the care as usual group, receives the standard procedure during wound care without 'VRelax' VR system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Virtual Reality Therapy (Intervention group 1) |
Primary outcome
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
The VAS is a horizontal scale from 0 to 10, with 0 indicating ''no pain'' and 10 indicating ''worst pain possible''.
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marlies Schijven, Prof. dr. principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality ('VRelax' VR system) in people with Wound and Wound and Injuries, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.