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Virtual Reality - A New Vision on Pain

Virtual Reality - A New Vision on Pain

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06045741
Acronym
VROP
Enrollment
33
Registered
2023-09-21
Start date
2023-09-01
Completion date
2024-08-18
Last updated
2025-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Back Pain, Chronic Pain, Musculoskeletal Diseases or Conditions, Musculoskeletal Disorder, Musculoskeletal Neck Pain, Musculoskeletal Pain, Pain, Chronic

Keywords

Virtual Reality, VR, Long lasting pain, Long-term

Brief 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. 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.

Interventions

None listed

Sponsors

Sykehuset i Vestfold HF
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* pain duration \> 3 moths * Master Norwegian spoken language

Exclusion criteria

* History of malignant disease * pain duration \< 3 Months * Does not master Norwegian spoken language * Epilepsy

Design outcomes

Primary

MeasureTime frameDescription
PROMIS Pain interferenceThree monthsConsequences 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 intensityThree monthsNumeric rating scale (NRS (0-10)) How much a person hurts

Secondary

MeasureTime frameDescription
PROMIS Physical FunctionThree monthsSelf-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.
PROMIS Emotional Distress - AnxietyThree monthsFear (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.
PROMIS Emotional Distress - DepressionThree monthsNegative 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.
System Usability Scale (SUS)Three monthsThe 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.
PROMIS Social Health - Ability to Participate in Social Roles and ActivitiesThree monthsPerceived 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.
PROMIS Physical Health - FatigueThree monthsRange 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.
RTWSE-11 Return ti work self efficacyThree monthsThe 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.
PROMIS Physical Health - Sleep DisturbanceThree monthsPerceptions 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.
EQ-5D-5LThree monthsHealth 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

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026