Chronic PainVROPNCT06045741
Virtual Reality - A New Vision on Pain
An observational study of Chronic Pain and Pain, Chronic, run by Sykehuset i Vestfold HF at 1 site in Norway.
Trial summary
The purpose of the project is to investigate if the use of virtual reality (VR) technology with pre-programmed proprietary software can provide better treatment for patients with long-term pain conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Pain, Chronic, Musculoskeletal Disorder
- How many people
- 33 participants
- Where
- 1 siteNorway
- Study dates
- 1 Sep 2023to 18 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients with chronic pain conditions, referred to the outpatient clinic at the division of physical medicine and rehabilitation at Vestfold Hospital Trust.
Who may be able to join
- pain duration > 3 moths
- Master Norwegian spoken language
Who cannot join
- History of malignant disease
- pain duration < 3 Months
- Does not master Norwegian spoken language
- Epilepsy
Trial locations and contacts
1 site in 1 country.
Norway1 site
Klinikk fysikalsk medisin og rehabilitering, Sykehuset i Vestfold
Tønsberg
About this study
The purpose of the project is to investigate if the use of virtual reality (VR) technology with pre-programmed proprietary software can provide better treatment for patients with long-term pain conditions. This is investigated in this pilot study conducted on patients referred to outpatient treatment at the Division of Physical Medicine and Rehabilitation. The pilot study will lay the foundation for a follow-up study (RCT). The effect of VR are evaluated by patient reporting forms; before start-up and 3 months after startup. Patients included in the study receive standard treatment supplemented with the use of VR technology.
The therapists involved will be Interviewed to examine their experiences with the use of the VR-technology in the treatment of patients.
VR technology can potentially contribute to better treatment (e.g. measured in outcomes such as activity, sleep problems, pain intensity, quality of life). Moreover we expect that a VR-assisted treatment to be more cost-effective and increased availability regardless of geography and demography.
- Conditions
- Chronic Pain, Pain, Chronic, Musculoskeletal Disorder, Musculoskeletal Pain, Musculoskeletal Diseases or Conditions, Musculoskeletal Neck Pain
- Keywords
- Virtual Reality, VR, Long lasting pain, Long-term
- Medical subject headings
- Chronic Pain, Musculoskeletal Diseases, Musculoskeletal Pain, Back Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS Pain interference
Consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities.
PROMIS measures are scored on the T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
Measured: Three months
PROMIS Pain intensity
Numeric rating scale (NRS (0-10)) How much a person hurts
Measured: Three months
Secondary outcomes (9)
System Usability Scale (SUS)
The System Usability Scale (SUS) provides a reliable tool for measuring the usability. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree.
Measured: Three months
EQ-5D-5L
Health related quality of life; The Health Utilities Index is a rating scale used to measure general health status and health-related quality of life.
Range fra
Measured: Three months
PROMIS Physical Function
Self-reported capability rather than actual performance of physical activities. PROMIS measures are scored on the T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
Measured: Three months
PROMIS Emotional Distress - Anxiety
Fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart,dizziness).
PROMIS measures are scored on the T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
Measured: Three months
PROMIS Emotional Distress - Depression
Negative mood (sadness, guilt), views of self (self- criticism,worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose).
PROMIS measures are scored on the T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
Measured: Three months
PROMIS Physical Health - Sleep Disturbance
Perceptions of sleep quality, sleep depth, and restoration associated with sleep.
PROMIS measures are scored on the T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
Measured: Three months
PROMIS Social Health - Ability to Participate in Social Roles and Activities
Perceived ability to perform one's usual social roles and activities. PROMIS measures are scored on the T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
Measured: Three months
PROMIS Physical Health - Fatigue
Range of symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles.
PROMIS measures are scored on the T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
Measured: Three months
RTWSE-11 Return ti work self efficacy
The return to work self efficacy (RTW-SE) score quantifies an individual's confidence in their ability to work fully and perform work tasks while suffering from chronic pain conditions.
The score ranges between 1 and 6, higher scores are better.
Threshold values identified in Norwegian samples:
Scores from 3.7 and lower are considered low and are associated with a lower probability of return to work. Scores from 4.6 and above are considered to be high and are associated with a higher probability of return to work.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Sep 2023
- Primary completion18 Aug 2024
- Study completion18 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset i Vestfold HF
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inge Ringheim, Sykehuset i Vestfold HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06045741
- Sponsor's protocol ID
- 21/00032
- Acronym
- VROP
- Status last verified
- Nov 2024
- First submitted
- 13 Sep 2023
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality - A New Vision on Pain
- ClinicalTrials.gov ID
- NCT06045741
- Acronym / sponsor ID
- VROP / 21/00032
- Conditions
- Chronic Pain, Pain, Chronic, Musculoskeletal Disorder, Musculoskeletal Pain, Musculoskeletal Diseases or Conditions, Musculoskeletal Neck Pain
- Keywords
- Virtual Reality, VR, Long lasting pain, Long-term
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Sykehuset i Vestfold HFUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 18 Aug 2024 (actual)
- Study completion
- 18 Aug 2024 (actual)
- First posted
- 21 Sep 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 purpose of the project is to investigate if the use of virtual reality (VR) technology with pre-programmed proprietary software can provide better treatment for patients with long-term pain conditions. This is investigated in this pilot study conducted on patients referred to outpatient treatment at the Division of Physical Medicine and Rehabilitation. The pilot study will lay the foundation for a follow-up study (RCT). The effect of VR are evaluated by patient reporting forms; before start-up and 3 months after startup. Patients included in the study receive standard treatment supplemented with the use of VR technology.
The therapists involved will be Interviewed to examine their experiences with the use of the VR-technology in the treatment of patients.
VR technology can potentially contribute to better treatment (e.g. measured in outcomes such as activity, sleep problems, pain intensity, quality of life). Moreover we expect that a VR-assisted treatment to be more cost-effective and increased availability regardless of geography and demography.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic pain conditions, referred to the outpatient clinic at the division of physical medicine and rehabilitation at Vestfold Hospital Trust.
Key inclusion criteria (2 listed)
- pain duration > 3 moths
- Master Norwegian spoken language
Key exclusion criteria (4 listed)
- History of malignant disease
- pain duration < 3 Months
- Does not master Norwegian spoken language
- Epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PROMIS Pain interference
Time frame: Three months
Consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. PROMIS measures are scored on the T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
PROMIS Pain intensity
Time frame: Three months
Numeric rating scale (NRS (0-10)) How much a person hurts
9 secondary outcomes
System Usability Scale (SUS)
Time frame: Three months
EQ-5D-5L
Time frame: Three months
PROMIS Physical Function
Time frame: Three months
PROMIS Emotional Distress - Anxiety
Time frame: Three months
PROMIS Emotional Distress - Depression
Time frame: Three months
PROMIS Physical Health - Sleep Disturbance
Time frame: Three months
PROMIS Social Health - Ability to Participate in Social Roles and Activities
Time frame: Three months
PROMIS Physical Health - Fatigue
Time frame: Three months
RTWSE-11 Return ti work self efficacy
Time frame: Three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Pain, Chronic, run by Sykehuset i Vestfold HF at 1 site in Norway.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 18 May 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 Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PROMIS Pain interference (time frame: Three months). The study lists 2 primary outcomes in all. 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 18 May 2025.