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OpenTrials
Completed

NCT Number: NCT06045741

Virtual Reality - A New Vision on Pain

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.

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Key information

Conditions

Chronic Pain Back Pain Muscular Diseases Musculoskeletal Diseases Musculoskeletal Diseases or Conditions Musculoskeletal Disorder Musculoskeletal Neck Pain Musculoskeletal Pain Neurologic Manifestations Pain Pain, Chronic Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikk fysikalsk medisin og rehabilitering, Sykehuset i Vestfold

Tønsberg, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. PROMIS Pain intensity

    Time frame: Three months

    Numeric rating scale (NRS (0-10)) How much a person hurts

Secondary outcomes

  1. System Usability Scale (SUS)

    Time frame: Three months

    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.

  2. EQ-5D-5L

    Time frame: Three months

    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

  3. PROMIS Physical Function

    Time frame: Three months

    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.

  4. PROMIS Emotional Distress - Anxiety

    Time frame: Three months

    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.

  5. PROMIS Emotional Distress - Depression

    Time frame: Three months

    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.

  6. PROMIS Physical Health - Sleep Disturbance

    Time frame: Three months

    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.

  7. PROMIS Social Health - Ability to Participate in Social Roles and Activities

    Time frame: Three months

    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.

  8. PROMIS Physical Health - Fatigue

    Time frame: Three months

    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.

  9. RTWSE-11 Return ti work self efficacy

    Time frame: Three months

    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.

Sponsors and collaborators

Lead sponsor

Sykehuset i Vestfold HF

Other

Registry information

Acronym: VROP

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 21, 2023
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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