Preventive Interventions for Chronic Pain Worsening
ConditionChronic Non-Cancer Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRigshospitalet, Denmark
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Specialized or multidisciplinary pain treatment at baseline
History of epilepsy
Seizure disorder
History of nausea or dizziness
Trial design
Design model
Factorial
Treatments tested in this trial
Virtual Reality-based Pain Self-management program
DeviceThe 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.
Treatment groups
44 Participants
are divided into 2 treatment groupsGroup A: VRPS programExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
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)
Time frame
At baseline, 2 months, 6 months, 9 months and 12 months after interventionSecondary outcomes
1
Pain intensity and interference in daily activities
Brief Pain Inventory to measure pain intensity from no pain (0) to worst pain ever (10) at follow-ups and interference on general activity, mood, walking ability, work, social relations, sleep, and enjoyment of life
Time frame
At baseline, 2 months, 6 months, 9 months and 12 months after intervention2
Pain catastrophizing
Pain Catastrophizing Scale, using a 5-point Likert scale ranging from 0 (never) to 4 (always) to assess patterns of negative cognition and emotion in the context of actual or anticipated pain
Time frame
At baseline, 2 months, 6 months, 9 months and 12 months after intervention3
Pain acceptance
Chronic Pain Acceptance Questionnaire to assess engagement in activity (despite pain), pain willingness, and total pain acceptance score, using a rating scale from 0 to 6. Never true (0) to always true (6)
Time frame
At baseline, 2 months, 6 months, 9 months and 12 months after intervention4
Health status
patient-generated outcome assessed by the Measure Yourself Medical Outcome Profile (MYMOP2), which measures effects from health care interventions on physical, emotional, or social symptoms/problems. It is problem-specific and includes general wellbeing
Time frame
At baseline, 2 months, 6 months, 9 months and 12 months after interventionOther outcomes
1
Satisfaction with the intervention
Satisfaction with the intervention will be asked to the intervention group by general questions about the intervention experienced with answers in a 6-point scale (0=completely dissatisfied to 5= completely satisfied) and there will be space to write comments.
Time frame
At 2 months, 6 months, 9 months and 12 months after interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Rigshospitalet, Denmark
Lead sponsor
The Novo Nordic Foundation
Collaborator
Source ClinicalTrials.gov