VROP: Virtual Reality - A New Vision on Pain

Sponsor
Sykehuset i Vestfold HF (Other)
Overall Status
Recruiting
CT.gov ID
NCT06045741
Collaborator
(none)
50
1
15
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Study Details

Study Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Virtual Reality - A New Vision on Pain
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2024

Outcome Measures

Primary Outcome Measures

  1. PROMIS Pain interference [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 [Three months]

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

Secondary Outcome Measures

  1. System Usability Scale (SUS) [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 [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 [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 [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Klinikk fysikalsk medisin og rehabilitering, Sykehuset i Vestfold Tønsberg Norway

Sponsors and Collaborators

  • Sykehuset i Vestfold HF

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Inge Ringheim, PhD, Sykehuset i Vestfold HF
ClinicalTrials.gov Identifier:
NCT06045741
Other Study ID Numbers:
  • 21/00032
First Posted:
Sep 21, 2023
Last Update Posted:
Sep 26, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Inge Ringheim, PhD, Sykehuset i Vestfold HF
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 26, 2023