Preventive Interventions for Chronic Pain Worsening

NCT06351046 | Recruiting

• 1 other identifier: NCT05178082_WP3
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Non-Cancer Pain

Keywords

Patient Reported Outcome; Virtual Reality; Pain Intensity; Randomized Controlled Trial; Non-pharmacological treatment

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  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)

  At baseline, 2 months, 6 months, 9 months and 12 months after intervention

Secondary Outcomes (10)

• Pain intensity and interference in daily activities

  At baseline, 2 months, 6 months, 9 months and 12 months after intervention

• Pain catastrophizing

  At baseline, 2 months, 6 months, 9 months and 12 months after intervention

• Pain acceptance

  At baseline, 2 months, 6 months, 9 months and 12 months after intervention

• Health status

  At baseline, 2 months, 6 months, 9 months and 12 months after intervention

• Health related quality of life

  At baseline, 2 months, 6 months, 9 months and 12 months after intervention

Other Outcomes (1)

• Satisfaction with the intervention

  At baseline, 2 months, 6 months, 9 months and 12 months after intervention

Study Arms (2)

VRPS program

EXPERIMENTAL

VRPS is based on four evidence-based principles of cognitive-behavioral therapy and pain neuroscience education. For this project we have selected relaxation, mindful escapes, pain distraction games, and dynamic breathing modules.The eight consecutive weeks program period of intervention is composed of one initial physical meeting with 1h duration to explain the basis/principles of the virtual tools offered, how the virtual appliance works and should be used, including safety recommendations as calm environment at home, sitting or lying position during use. Groups of maximum 13 patients will be organized. Patients will be instructed to use the equipment at least once a day and it can be used as many times as they wish per day aiming to reduce pain intensity or to avoid pain. Patients will also be asked to keep a diary to register the equipment use during the study period to secure the data.

Device: Virtual Reality-based Pain Self-management program

Control group

NO INTERVENTION

Participants in the control group will not receive any of the interventions. This study will not interfere with medical treatment plan and patients from the three groups can receive other pain treatment prescribed by physician.

Interventions

Virtual Reality-based Pain Self-management program DEVICE

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.

Also known as: VRPS

VRPS program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• The Novo Nordic Foundation: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, København Ø., 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Geana Kurita, PhD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Geana Kurita, PhD

CONTACT

35454797; geana.kurita@regionh.dk

Suzanne F Forsyth Herling, PhD

CONTACT

35458624; suzanne.forsyth.herling.01@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The statistical analysis of the data will be blinded
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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 VRPS group, and a control group (usual care). Participants will be randomly assigned to one of the groups. Assessments will occur at baseline and 2, 6, 9, and 12 months after intervention.

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 8, 2024
• Study Start: May 14, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

DK (1)