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Completed

NCT Number: NCT06312735

VR for Patients With Chronic Pain (Wait & Work)

This cluster-RCT evaluates the effect of therapeutic virtual reality (VR) on patients with chronic musculoskeletal pain (CMP) who are on a waiting list to receive pain treatment. The used VR application, Reducept, offers pain education and pain management techniques. This home-based, stand-alone, immersive VR intervention was used daily for four weeks in the intervention group. The control group received standard care (no treatment). Primary outcome measure for this study was health-related quality of life, secondary outcome measures included various pain-related variables (e.g. pain self-efficacy and acceptance. Outcome variables will be measured after four weeks and follow-up after six months.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Deventer Ziekenhuis, Deventer, Overijssel, Netherlands

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • aged 18 years or older
  • suffering from primary or secondary CMP
  • finished with biomedical diagnostics and treatment
  • open to biopsychosocial treatment
  • willing and capable of complying with study procedures.

Exclusion criteria

  • not able to finish the VR intervention due to physical (e.g. visual impairment), mental (e.g. severe sensitivity to stimuli) or practical problems (e.g. insufficient tech-literacy)
  • unable to finish Dutch questionnaires.

Treatment and study plan

VR (Reducept)

Device

Reducept is a novel VR intervention that consists of a combination of pain neuroscience education (PNE) and pain management techniques. It includes different psychological therapy modalities (e.g. acceptance and commitment therapy (ACT), cognitive behavioral therapy (CBT) and hypnotherapy) into a single application.

Primary outcomes

  1. Change in quality of life measured using the short-form 12 (SF-12)

    Time frame: Baseline, directly after the intervention, and at six months follow-up

    This questionnaire on quality of life scores from 12 (worst possible score) to 56 (best possible score)

Secondary outcomes

  1. Change in pain intensity measured using the numeric pain rating scale (NPRS)

    Time frame: Baseline, directly after the intervention, and at six months follow-up

    This questionnaire on pain intensity scores from 0 (best possible score) to 100 (worst possible score)

  2. Change in pain catastrophizing measured using the pain catastrophizing scale (PCS)

    Time frame: Baseline, directly after the intervention, and at six months follow-up

    This questionnaire on pain catastrophizing scores from 0 (best possible score) to 52 (worst possible score).

  3. Change in pain self-efficacy measured using the pain self-efficacy questionnaire (PSEQ)

    Time frame: Baseline, directly after the intervention, and at six months follow-up

    This questionnaire scores from 0 (worst possible score) to 60 (best possible score).

  4. Change in pain acceptance measured using the chronic pain acceptance questionnaire (CPAQ-8)

    Time frame: Baseline, directly after the intervention, and at six months follow-up

    This questionnaire scores from 0 (worst possible score) to 48 (best possible score).

  5. Change in feelings of anxiety and depression measured using the hospital anxiety and depression scale (HADS)

    Time frame: Baseline, directly after the intervention, and at six months follow-up

    This questionnaire scores from 0 (worst possible score) to 42 (best possible score).

  6. Change in quality of care measured using the client satisfaction questionnaire (CSQ-8)

    Time frame: Baseline, directly after the intervention, and at six months follow-up

    This questionnaire scores from 8 (worst possible score) to 32 (best possible score).

  7. Change in medication use measured using an open-ended question

    Time frame: Baseline, directly after the intervention, and at six months follow-up

    This question inquires about current medication use

Sponsors and collaborators

Lead sponsor

University of Twente

Other

Registry information

Official study title

Cluster-randomized Controlled Trial of Virtual Reality for Patients With Chronic Musculoskeletal Pain (Wait & Work)

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 15, 2024
Registry last updated
Apr 11, 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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