NCT06045741

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2024

Completed
Last Updated

May 18, 2025

Status Verified

November 1, 2024

Enrollment Period

12 months

First QC Date

September 13, 2023

Last Update Submit

May 13, 2025

Conditions

Keywords

Virtual RealityVRLong lasting painLong-term

Outcome Measures

Primary Outcomes (2)

  • 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.

    Three months

  • PROMIS Pain intensity

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

    Three months

Secondary Outcomes (9)

  • System Usability Scale (SUS)

    Three months

  • EQ-5D-5L

    Three months

  • PROMIS Physical Function

    Three months

  • PROMIS Emotional Distress - Anxiety

    Three months

  • PROMIS Emotional Distress - Depression

    Three months

  • +4 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with chronic pain conditions, referred to the outpatient clinic at the division of physical medicine and rehabilitation at Vestfold Hospital Trust.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikk fysikalsk medisin og rehabilitering, Sykehuset i Vestfold

Tønsberg, Norway

Location

MeSH Terms

Conditions

Chronic PainMusculoskeletal DiseasesMusculoskeletal PainBack Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

September 13, 2023

First Posted

September 21, 2023

Study Start

September 1, 2023

Primary Completion

August 18, 2024

Study Completion

August 18, 2024

Last Updated

May 18, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations