Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06351046
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-03-27
Brief Title:
Preventive Interventions for Chronic Pain Worsening
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Preventive Interventions for Chronic Pain Worsening
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 three arms 111 Mindfulness Based Stress Reduction MBSR group Virtual Reality based Pain Self-management VRPS program group and a control group usual care Included will be 78 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
Detailed Description:
Considering the need of interventions to improve pain self-management to interrupt the pain chronification process and the indications regarding advantages of cognitive behavioral techniques and technologic resources the purpose of this study is to test homebased interventions connecting these two areas Here the effects of an online delivered standardized mindfulness-based stress reduction program and non-pharmacological techniques delivered through a virtual reality-based pain self-management program will be tested in patients with non-cancer pain lasting three months or more Both interventions target primarily pain relief by providing pain regulating strategies
The investigators will test the main hypothesis that participants assigned to Mindfulness-Based Stress Reduction MBSR or Virtual Reality-based Pain Self-management program VRPS present reduction of pain intensity among other outcomes at 2 months post-intervention as well as after 6- 9- and 12-months follow-up when compared to treatment as usual control groupThe primary aim is to investigate the effects of MBSR and VRPS on worst pain intensity in the last 24h in patients with non-cancer pain lasting 3 months or more at 2 months post-interventionThe secondary aims are to analyze the effects of both interventions on other patient-reported outcomes measures PROMs which are pain intensity at follow-ups pain interference in daily activities pain catastrophizing pain acceptance health-related quality of life anxiety depression perceived change on over-all pain status use of analgesic medication and use of health care system among patients with non-cancer pain lasting 3 months or more In addition the effects of the two interventions will be compared
The investigators will test the main hypothesis that participants assigned to Mindfulness-Based Stress Reduction MBSR or Virtual Reality-based Pain Self-management program VRPS present reduction of pain intensity among other outcomes at 2 months post-intervention as well as after 6- 9- and 12-months follow-up when compared to treatment as usual control groupThe primary aim is to investigate the effects of MBSR and VRPS on worst pain intensity in the last 24h in patients with non-cancer pain lasting 3 months or more at 2 months post-interventionThe secondary aims are to analyze the effects of both interventions on other patient-reported outcomes measures PROMs which are pain intensity at follow-ups pain interference in daily activities pain catastrophizing pain acceptance health-related quality of life anxiety depression perceived change on over-all pain status use of analgesic medication and use of health care system among patients with non-cancer pain lasting 3 months or more In addition the effects of the two interventions will be compared
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None