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Recruiting Not applicable

Preventive Interventions for Chronic Pain Worsening

NCT06351046 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2025-05-14
Last updated
2026-07-09

Condition(s) studied

Chronic Non-Cancer Pain

Investigational drug(s) / intervention(s)

Virtual Reality-based Pain Self-management program

Virtual Reality-based Pain Self-management program: The VRPS has a variety of modules that can be used for pain management. For this project we have selected relaxation, mindful escapes, pain distraction games, and dynamic breathing modules. All modules were designed to minimize triggers of emotional distress or cybersickness.

Study summary

This is an open label randomized controlled trial (RCT), which will be conducted with patients of the Copenhagen Wound Healing Center at Bispebjerg Hospital in Copenhagen (DK). The trial has two arms (1:1): A Virtual Reality based Pain Self-management (VRPS) program group, and a control group (usual care). Included will be 44 patients at least 18 years old; fluent in the Danish language; complaint of pain lasting 3 months or more; in average pain intensity score ≥ 3 (numerical rating scale 0 to 10); access to internet; and willing and available to participate in the study. Excluded will be specialized or multidisciplinary pain treatment at baseline; history of epilepsy, seizure disorder, nausea or dizziness, hypersensitivity to flashing light or motion or other diseases that may prevent use of virtual reality equipment; injury to eyes, face or neck.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * At least 18 years old * Fluent in the Danish language * Complaint of pain lasting 3 months or more; in average pain intensity score ≥ 3 (numerical rating scale 0 to 10) * Access to internet * Willing and available to participate in the study. Exclusion Criteria: * Specialized or multidisciplinary pain treatment at baseline * History of epilepsy * Seizure disorder * History of nausea or dizziness * Hypersensitivity to flashing light or motion or other diseases that may prevent use of virtual reality equipment. * Injury to eyes, face or neck that impedes comfortable use of virtual reality equipment. * Current cancer disease * Medical diagnosis of depression * Cognitive dysfunction that interferers with compliance to the study, * Currently pregnant or planning to become pregnant during the study period * No access to the internet during the study period.

Primary outcome measure(s)

  • Pain intensity — At baseline, 2 months, 6 months, 9 months and 12 months after intervention
    Pain intensity for worst pain in the last 24h: Brief Pain Inventory to measure pain intensity, from no pain (0) to worst pain ever (10)

Trial sites (1)

FacilityCityRegionStatus
Rigshospitalet Copenhagen København Ø. Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06351046 on ClinicalTrials.gov ↗ ← All trials in Denmark