Preventive Interventions for Chronic Pain Worsening
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
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.
详细描述
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 a homebased intervention connecting these areas. Here, the effects of a non-pharmacological technique delivered through a virtual reality-based pain self-management program will be tested in patients with non-cancer pain lasting three months or more. The intervention target primarily pain relief by providing pain regulating strategies.
The investigators will test the main hypothesis that participants assigned 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 group).The primary aim is to investigate the effects of VRPS on worst pain intensity in the last 24h in patients with non-cancer pain lasting 3 months or more at 2 months post-intervention.The secondary aims are to analyze the effects of the intervention 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
盲法说明
The statistical analysis of the data will be blinded
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
VRPS program
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.
干预措施: Virtual Reality-based Pain Self-management program (Device)
Control group
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.
结局指标
主要结局
Pain intensity
时间窗: 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)
次要结局
- Pain acceptance(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)
- Health status(At baseline, 2 months, 6 months, 9 months and 12 months after intervention)
- Use of medication(At baseline, 2 months, 6 months, 9 months and 12 months after intervention)
- Pain intensity and interference in daily activities(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)
- Depression(At baseline, 2 months, 6 months, 9 months and 12 months after intervention)
- Use of healthcare system(At baseline, 2 months, 6 months, 9 months and 12 months after intervention)
- Anxiety(At baseline, 2 months, 6 months, 9 months and 12 months after intervention)
- Number of absent days at work(At baseline, 2 months, 6 months, 9 months and 12 months after intervention)
研究者
Geana P Kurita
Professor
Rigshospitalet, Denmark