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临床试验/NCT02661724
NCT02661724已完成不适用

Take Charge of Burn Pain: A Randomized Controlled Trial of a Web-based Self-Management Intervention to Improve Burn Pain Outcomes

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 137 人开始时间: 2015年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
137
试验地点
1
主要终点
Change in Pain Severity and Pain-Related Interference

研究概览

简要总结

Persons with burn-related pain remain under treated and do not have access to comprehensive burn pain management. We seek to extend evidence-based cognitive behavioral pain management strategies to a group of burn survivors that are currently under treated for for burn pain with a specific goal of reducing pain related interference in life activities.

Investigators will conduct a randomized controlled trial to test the central hypothesis that a computer-based cognitive-behavioral program (Take Charge of Burn Pain) will improve pain management, psychological health, and improve participation in burn survivors. Specific aims include: 1) to determine the efficacy of a web-based self-management intervention in reducing pain and pain-related interference and increasing pain management self-efficacy; and 2) to determine whether Take Charge of Burn Pain improves psychological health and participation in life activities in persons with burn injury pain. Emerging research suggests that web-based pain management interventions may be a feasible and effective alternative to clinic-based interventions for patients with mobility and geographic restrictions, such as those treated at tertiary burn centers.

详细描述

Burns are among the most painful of all injuries requiring painful daily wound care and rehabilitation procedures. Despite the best efforts of burn care professionals, burns frequently result in acute and chronic suffering and poor functional outcomes for otherwise healthy individuals with many years of productive life remaining. The evidence base directing burn pain management is generally weak, with much work based on clinical preferences rather than scientific evidence. There is a tremendous need for clinical trials to evaluate and improve the standard of care. While pharmacological treatment options are widely available for burn survivors throughout the emergent, acute, and rehabilitation phases of healing there is limited access to comprehensive pain management. It is critical to establish accessible pain management approaches that address the emotional, cognitive and physical dimensions of the burn pain experience. Cognitive behavioral therapy (CBT) has proven effective for patients with chronic pain and studies have demonstrated the efficacy of providing tele-rehabilitation CBT services for improving outcomes in persons with disability. However, tele-rehabilitation CBT pain management has not been traditionally offered or studied in persons with burn-related pain. The population of burn survivors has limited access to comprehensive pain management including CBT due to lack of access, financial constraints, and mobility issues that render clinic-based CBT impractical. Innovative rehabilitation interventions and delivery methods are needed to improve pain, functional, psychological and participation outcomes in burn survivors with significant, yet untreated, pain problems.

Investigators propose to conduct a two group randomized controlled trial to test the central hypothesis that web-based CBT will improve pain severity, pain interference, self-efficacy, psychological health and participation in life activities for burn survivors with pain. Emerging research suggests that tele-rehabilitation may be a feasible, and effective alternative (with much broader applicability) to clinic-based interventions for patients with access restrictions. This project will address 2 specific aims:

Specific Aim 1: To determine the efficacy of a web-based, CBT self-management intervention (Take Charge of Burn Recovery - Pain [TCBR-Pain) in improving pain management self-efficacy, and reducing pain and pain-related interference in burn survivors with pain.

Outcomes will be measured using a battery of standardized tests at baseline, 2 month (treatment completion) and 5 month post-treatment follow-up. Self-reported pain self-efficacy, pain severity and pain interference will be measured using validated instruments (Pain Self-efficacy Scale, Brief Pain Inventory respectively).

Hypothesis 1: TCBR- Pain participants will demonstrate significantly greater improvement in pain self-efficacy, pain severity and pain interference relative to the attention-control group at 2 month (treatment completion) and 5 month follow up.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Persons ages 18 to 70 years old having experienced a burn injury requiring hospitalization at least 6 months prior to enrollment;
  • •Reporting a pain severity score on the Brief Pain inventory of 4 (0-10) or higher;
  • •Reporting pain of at least 3 months duration; and
  • •English speaking due to feasibility of providing the web-based intervention only in English at this time.

排除标准

  • •Significant neurological or psychiatric condition precluding informed consent.
  • •Lack of access to a computer that is connected to the worldwide web.

研究组 & 干预措施

Take Charge Burn - Pain (TCBR-Pain)

Experimental

The TCBR-Pain program includes 7 lessons addressing key dimensions of pain management for persons with burn injury. Each session is about 20 minutes and focuses on burn injury recovery and life style education. Sessions begin with a brief self-assessment and in later sessions, the participant is given graphical feedback on their progress.

干预措施: TCBR-Pain (Behavioral)

Education attention control

No Intervention

The attention group receives an educational materials that is matched to the TCBR-Pain intervention in terms of session length and time on the web-based program. The web-based Education attention condition includes 7 sessions delivered over 7 weeks. The Education Attention Control is education materials commonly employed in rehabilitation centers and has been successfully used in several studies as a comparison to active rehabilitation interventions

结局指标

主要结局

Change in Pain Severity and Pain-Related Interference

时间窗: 2 and 5 month

The Brief Pain Inventory (BPI) will be used to assess pain severity and establish that the pain intensity inclusion criteria are met. The BPI includes two primary dimensions: pain severity (4 items) and pain interference (7 items), each rated on 0 to 10 scales.

次要结局

  • Change in Participation in life activities(2 and 5 month)
  • Change in PTSD Anxiety(2 and 5 month)
  • Change in Depression(2 and 5 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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