Chronic Non-Cancer PainNCT06351046
Preventive Interventions for Chronic Pain Worsening
A study testing Virtual Reality-based Pain Self-management program in people with Chronic Non-Cancer Pain, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
This is an open label randomized controlled trial (RCT), which will be conducted with patients of the Copenhagen Wound Healing Center at Bispebjerg Hospital in Copenhagen (DK). The trial has two arms (1:1): A Virtual Reality based Pain Self-management (VRPS) program group, and a control group (usual care). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Non-Cancer Pain
- What is being tested?
- Virtual Reality-based Pain Self-management program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteDenmark
- Study dates
- 14 May 2025to 31 Dec 2027
- 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
- At least 18 years old
- Fluent in the Danish language
- Complaint of pain lasting 3 months or more; in average pain intensity score ≥ 3 (numerical rating scale 0 to 10)
- Access to internet
- Willing and available to participate in the study.
Who cannot join
- Specialized or multidisciplinary pain treatment at baseline
- History of epilepsy
- Seizure disorder
- History of nausea or dizziness
- Hypersensitivity to flashing light or motion or other diseases that may prevent use of virtual reality equipment.
- Injury to eyes, face or neck that impedes comfortable use of virtual reality equipment.
Show all 11Show fewer
- Current cancer disease
- Medical diagnosis of depression
- Cognitive dysfunction that interferers with compliance to the study,
- Currently pregnant or planning to become pregnant during the study period
- No access to the internet during the study period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen, København Ø., 2100
Geana Kurita, PHD.
Suzanne Herling, PHD
About this study
This is an open label randomized controlled trial (RCT), which will be conducted with patients of the Copenhagen Wound Healing Center at Bispebjerg Hospital in Copenhagen (DK). The trial has two arms (1:1): A Virtual Reality based Pain Self-management (VRPS) program group, and a control group (usual care). Included will be 44 patients at least 18 years old; fluent in the Danish language; complaint of pain lasting 3 months or more; in average pain intensity score ≥ 3 (numerical rating scale 0 to 10); access to internet; and willing and available to participate in the study. Excluded will be specialized or multidisciplinary pain treatment at baseline; history of epilepsy, seizure disorder, nausea or dizziness, hypersensitivity to flashing light or motion or other diseases that may prevent use of virtual reality equipment; injury to eyes, face or neck.
Read the detailed description
Considering the need of interventions to improve pain self-management to interrupt the "pain chronification" process and the indications regarding advantages of cognitive behavioral techniques and technologic resources, the purpose of this study is to test a homebased intervention connecting these areas. Here, the effects of a non-pharmacological technique delivered through a virtual reality-based pain self-management program will be tested in patients with non-cancer pain lasting three months or more. The intervention target primarily pain relief by providing pain regulating strategies.
The investigators will test the main hypothesis that participants assigned Virtual Reality-based Pain Self-management program (VRPS) present reduction of pain intensity among other outcomes at 2 months post-intervention as well as after 6-, 9-, and 12-months follow-up when compared to treatment as usual (control group).The primary aim is to investigate the effects of VRPS on worst pain intensity in the last 24h in patients with non-cancer pain lasting 3 months or more at 2 months post-intervention.The secondary aims are to analyze the effects of the intervention on other patient-reported outcomes measures (PROMs), which are pain intensity at follow-ups, pain interference in daily activities, pain catastrophizing, pain acceptance, health-related quality of life, anxiety, depression, perceived change on over-all pain status, use of analgesic medication, and use of health care system among patients with non-cancer pain lasting 3 months or more.
- Conditions
- Chronic Non-Cancer Pain
- Being tested
- Virtual Reality-based Pain Self-management program
- Keywords
- Patient Reported Outcome, Virtual Reality, Pain Intensity, Randomized Controlled Trial, Non-pharmacological treatment
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality-based Pain Self-management programDevice
Also called VRPS
The VRPS has a variety of modules that can be used for pain management. For this project we have selected relaxation, mindful escapes, pain distraction games, and dynamic breathing modules. All modules were designed to minimize triggers of emotional distress or cybersickness.
| Study group | Role | What they receive |
|---|---|---|
| VRPS program | Experimental | VRPS is based on four evidence-based principles of cognitive-behavioral therapy and pain neuroscience education. For this project we have selected relaxation, mindful escapes, pain distraction games, and dynamic breathing modules.The eight consecutive weeks program period of intervention is composed of one initial physical meeting with 1h duration to explain the basis/principles of the virtual tools offered, how the virtual appliance works and should be used, including safety recommendations as calm environment at home, sitting or lying position during use. Groups of maximum 13 patients will be organized. Patients will be instructed to use the equipment at least once a day and it can be used as many times as they wish per day aiming to reduce pain intensity or to avoid pain. Patients will also be asked to keep a diary to register the equipment use during the study period to secure the data. Receives: Device: Virtual Reality-based Pain Self-management program |
| Control group | No intervention | Participants in the control group will not receive any of the interventions. This study will not interfere with medical treatment plan and patients from the three groups can receive other pain treatment prescribed by physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity for worst pain in the last 24h: Brief Pain Inventory to measure pain intensity, from no pain (0) to worst pain ever (10)
Measured: At baseline, 2 months, 6 months, 9 months and 12 months after intervention
Secondary outcomes (10)
Pain intensity and interference in daily activities
Brief Pain Inventory to measure pain intensity from no pain (0) to worst pain ever (10) at follow-ups and interference on general activity, mood, walking ability, work, social relations, sleep, and enjoyment of life
Measured: At baseline, 2 months, 6 months, 9 months and 12 months after intervention
Pain catastrophizing
Pain Catastrophizing Scale, using a 5-point Likert scale ranging from 0 (never) to 4 (always) to assess patterns of negative cognition and emotion in the context of actual or anticipated pain
Measured: At baseline, 2 months, 6 months, 9 months and 12 months after intervention
Pain acceptance
Chronic Pain Acceptance Questionnaire to assess engagement in activity (despite pain), pain willingness, and total pain acceptance score, using a rating scale from 0 to 6. Never true (0) to always true (6)
Measured: At baseline, 2 months, 6 months, 9 months and 12 months after intervention
Health status
patient-generated outcome assessed by the Measure Yourself Medical Outcome Profile (MYMOP2), which measures effects from health care interventions on physical, emotional, or social symptoms/problems. It is problem-specific and includes general wellbeing
Measured: At baseline, 2 months, 6 months, 9 months and 12 months after intervention
Health related quality of life
Physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health using the RAND 36-Item Short Form Health Survey version 1.0. First, precoded numeric values are recoded per the scoring key. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
Measured: At baseline, 2 months, 6 months, 9 months and 12 months after intervention
Anxiety
General Anxiety Disorder - 7 (GAD-7) is commonly used as a measure of general anxiety severity. Measured on a rating scale,- "from not at all" (0) to "almost every day" (3)
Measured: At baseline, 2 months, 6 months, 9 months and 12 months after intervention
Depression
Patient Health Questionnaires scale (PHQ-9) can help track a patient's overall depression severity as well as track the improvement of specific symptoms with treatment. Measured on a rating scale,- from "not at all" (0) to "almost every day" (3)
Measured: At baseline, 2 months, 6 months, 9 months and 12 months after intervention
Use of medication
Medication used (type and quantity) The information collected will refer to the period from patient inclusion to up one year follow-up.
Measured: At baseline, 2 months, 6 months, 9 months and 12 months after intervention
Use of healthcare system
The number of times that he/she used the health care system because of his chronic pain problem and treatment received (pharmacologic, surgical, rehabilitation, etc.). The information collected will refer to the period from patient inclusion to up one year follow-up.
Measured: At baseline, 2 months, 6 months, 9 months and 12 months after intervention
Number of absent days at work
Number of absent days at work because of pain will be asked directly to the patients through the electronic forms. The information collected will refer to the period from patient inclusion to up one year follow-up.
Measured: At baseline, 2 months, 6 months, 9 months and 12 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start14 May 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Non-Cancer PainStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This is an open label randomized controlled trial (RCT), which will be conducted with patients of the Copenhagen Wound Healing Center at Bispebjerg Hospital in Copenhagen (DK). The trial has two arms (1:1) a VRPS group, and a control group (usual care). Participants will be randomly assigned to one of the groups. Assessments will occur at baseline and 2, 6, 9, and 12 months after intervention.
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- The Novo Nordic Foundation
- Responsible party
- Principal investigator, Geana P Kurita, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Geana Kurita, PhD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351046
- Sponsor's protocol ID
- NCT05178082_WP3
- Status last verified
- Apr 2026
- First submitted
- 27 Mar 2024
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive Interventions for Chronic Pain Worsening
- ClinicalTrials.gov ID
- NCT06351046
- Acronym / sponsor ID
- NCT05178082_WP3
- Conditions
- Chronic Non-Cancer Pain
- Keywords
- Patient Reported Outcome, Virtual Reality, Pain Intensity, Randomized Controlled Trial, Non-pharmacological treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- The Novo Nordic Foundation
- Study start
- 14 May 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Apr 2024 (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.
This is an open label randomized controlled trial (RCT), which will be conducted with patients of the Copenhagen Wound Healing Center at Bispebjerg Hospital in Copenhagen (DK). The trial has two arms (1:1): A Virtual Reality based Pain Self-management (VRPS) program group, and a control group (usual care). Included will be 44 patients at least 18 years old; fluent in the Danish language; complaint of pain lasting 3 months or more; in average pain intensity score ≥ 3 (numerical rating scale 0 to 10); access to internet; and willing and available to participate in the study. Excluded will be specialized or multidisciplinary pain treatment at baseline; history of epilepsy, seizure disorder, nausea or dizziness, hypersensitivity to flashing light or motion or other diseases that may prevent use of virtual reality equipment; injury to eyes, face or neck.
Detailed description
Considering the need of interventions to improve pain self-management to interrupt the "pain chronification" process and the indications regarding advantages of cognitive behavioral techniques and technologic resources, the purpose of this study is to test a homebased intervention connecting these areas. Here, the effects of a non-pharmacological technique delivered through a virtual reality-based pain self-management program will be tested in patients with non-cancer pain lasting three months or more. The intervention target primarily pain relief by providing pain regulating strategies.
The investigators will test the main hypothesis that participants assigned Virtual Reality-based Pain Self-management program (VRPS) present reduction of pain intensity among other outcomes at 2 months post-intervention as well as after 6-, 9-, and 12-months follow-up when compared to treatment as usual (control group).The primary aim is to investigate the effects of VRPS on worst pain intensity in the last 24h in patients with non-cancer pain lasting 3 months or more at 2 months post-intervention.The secondary aims are to analyze the effects of the intervention on other patient-reported outcomes measures (PROMs), which are pain intensity at follow-ups, pain interference in daily activities, pain catastrophizing, pain acceptance, health-related quality of life, anxiety, depression, perceived change on over-all pain status, use of analgesic medication, and use of health care system among patients with non-cancer pain lasting 3 months or more.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an open label randomized controlled trial (RCT), which will be conducted with patients of the Copenhagen Wound Healing Center at Bispebjerg Hospital in Copenhagen (DK). The trial has two arms (1:1) a VRPS group, and a control group (usual care). Participants will be randomly assigned to one of the groups. Assessments will occur at baseline and 2, 6, 9, and 12 months after intervention.
| Arm | Type | Receives |
|---|---|---|
| VRPS program | Experimental | Device: Virtual Reality-based Pain Self-management programVRPS is based on four evidence-based principles of cognitive-behavioral therapy and pain neuroscience education. For this project we have selected relaxation, mindful escapes, pain distraction games, and dynamic breathing modules.The eight consecutive weeks program period of intervention is composed of one initial physical meeting with 1h duration to explain the basis/principles of the virtual tools offered, how the virtual appliance works and should be used, including safety recommendations as calm environment at home, sitting or lying position during use. Groups of maximum 13 patients will be organized. Patients will be instructed to use the equipment at least once a day and it can be used as many times as they wish per day aiming to reduce pain intensity or to avoid pain. Patients will also be asked to keep a diary to register the equipment use during the study period to secure the data. |
| Control group | No intervention | –Participants in the control group will not receive any of the interventions. This study will not interfere with medical treatment plan and patients from the three groups can receive other pain treatment prescribed by physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years old
- Fluent in the Danish language
- Complaint of pain lasting 3 months or more; in average pain intensity score ≥ 3 (numerical rating scale 0 to 10)
- Access to internet
- Willing and available to participate in the study.
Key exclusion criteria (11 listed)
- Specialized or multidisciplinary pain treatment at baseline
- History of epilepsy
- Seizure disorder
- History of nausea or dizziness
- Hypersensitivity to flashing light or motion or other diseases that may prevent use of virtual reality equipment.
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-based Pain Self-management programAlso: VRPSThe VRPS has a variety of modules that can be used for pain management. For this project we have selected relaxation, mindful escapes, pain distraction games, and dynamic breathing modules. All modules were designed to minimize triggers of emotional distress or cybersickness. | Device | VRPS program |
Primary outcome
Pain intensity
Time frame: At baseline, 2 months, 6 months, 9 months and 12 months after intervention
Pain intensity for worst pain in the last 24h: Brief Pain Inventory to measure pain intensity, from no pain (0) to worst pain ever (10)
10 secondary outcomes
Pain intensity and interference in daily activities
Time frame: At baseline, 2 months, 6 months, 9 months and 12 months after intervention
Pain catastrophizing
Time frame: At baseline, 2 months, 6 months, 9 months and 12 months after intervention
Pain acceptance
Time frame: At baseline, 2 months, 6 months, 9 months and 12 months after intervention
Health status
Time frame: At baseline, 2 months, 6 months, 9 months and 12 months after intervention
Health related quality of life
Time frame: At baseline, 2 months, 6 months, 9 months and 12 months after intervention
Anxiety
Time frame: At baseline, 2 months, 6 months, 9 months and 12 months after intervention
Depression
Time frame: At baseline, 2 months, 6 months, 9 months and 12 months after intervention
Use of medication
Time frame: At baseline, 2 months, 6 months, 9 months and 12 months after intervention
Use of healthcare system
Time frame: At baseline, 2 months, 6 months, 9 months and 12 months after intervention
Number of absent days at work
Time frame: At baseline, 2 months, 6 months, 9 months and 12 months after intervention
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 9 Jul 2026.
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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.
Geana Kurita, PhD principal investigator
Copenhagen University Hospital, Rigshospitalet
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-based Pain Self-management program in people with Chronic Non-Cancer Pain, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 9 Jul 2026. 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 Denmark. 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?
Contact Geana Kurita, PhD (35454797, geana.kurita@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: At baseline, 2 months, 6 months, 9 months and 12 months after intervention). 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 9 Jul 2026.