Clinical trial NCT06312735: VR for Patients With Chronic Pain (Wait & Work)
Official title: Cluster-randomized Controlled Trial of Virtual Reality for Patients With Chronic Musculoskeletal Pain (Wait & Work)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: University of Twente
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in quality of life measured using the short-form 12 (SF-12)
timeFrame: Baseline, directly after the intervention, and at six months follow-up
Secondary outcomes:
measure: Change in pain intensity measured using the numeric pain rating scale (NPRS)
timeFrame: Baseline, directly after the intervention, and at six months follow-up
measure: Change in pain catastrophizing measured using the pain catastrophizing scale (PCS)
timeFrame: Baseline, directly after the intervention, and at six months follow-up
measure: Change in pain self-efficacy measured using the pain self-efficacy questionnaire (PSEQ)
timeFrame: Baseline, directly after the intervention, and at six months follow-up
measure: Change in pain acceptance measured using the chronic pain acceptance questionnaire (CPAQ-8)
timeFrame: Baseline, directly after the intervention, and at six months follow-up
measure: Change in feelings of anxiety and depression measured using the hospital anxiety and depression scale (HADS)
timeFrame: Baseline, directly after the intervention, and at six months follow-up
measure: Change in quality of care measured using the client satisfaction questionnaire (CSQ-8)
timeFrame: Baseline, directly after the intervention, and at six months follow-up
measure: Change in medication use measured using an open-ended question
timeFrame: Baseline, directly after the intervention, and at six months follow-up
Other outcomes:
Locations:
city: Emmeloord
country: Netherlands
facility: Revalidatie Friesland
state: Friesland
city: Deventer
country: Netherlands
facility: Deventer Ziekenhuis
state: Overijssel
city: Enschede
country: Netherlands
facility: Roessingh rehabilitation center
state: Overijssel
city: Hengelo
country: Netherlands
facility: Nocepta
state: Overijssel
Study officials:
References: