Pre-habilitation Interventions to Empower Patients With Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 163
- 试验地点
- 1
- 主要终点
- Change from baseline pain catastrophizing at 2, 6 and 12 months
研究概览
简要总结
The development of alternative methods to address simple clinical needs and easy interventions of self-application are desired in the pre-habilitation period (waiting list). To our knowledge that are very few studies regarding interventions for patients in waiting list for specialized treatment of chronic non-cancer pain (CNCP) and they do not include cognitive-behavioural programs. This project is based on the hypothesis that educational and cognitive-behavioural interventions help to reduce deleterious effects of pain on some areas of patient's life. Therefore, the goal is to test two different interventions to help patients to self-manage their pain and avoid worsening in the pre-clinical period.
详细描述
It is a randomized controlled trial for application and assessment of two interventions: an educational Video-based Pain Program (VP) and Empowered Relief Program (ER). The primary purpose of our study is to investigate the effect of ER and VP on the Pain Catastrophizing Score in people with CNCP who are waiting for Multidisciplinary pain treatment. The secondary aim is to analyse the effects on other patient reported outcomes such as pain intensity, pain interference in daily activities, pain catastrophizing, pain acceptance, quality of life, mood, perceived change on over-all pain status, as well as consumption of pain medicine and usage of healthcare services. The effects of the two interventions will be compared with each other and a control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Statistical analysis of 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
- •First appointment date at the Multidisciplinary Pain Centre scheduled at least three months after the invitation to participate in this study
- •At least 18 years old
- •Fluent in the Danish language
- •Access to internet
- •Willing and available to participate in the study
排除标准
- •History of cognitive dysfunction that interfere with understanding of the educational program and answering the questionnaires
- •Current history of severe depression
- •Current use of private pain services
研究组 & 干预措施
VP group
Participants are linked to online informative videos on chronic pain produced by the Multidisciplinary Pain Centre (Rigshospitalet, DK). Ten video-modules of 2-6 minutes each. 1. Chronic pain development in Denmark, treatment offered at the Centre. 2. How chronic pain can affect life in all its facets. Chronic complex pain explained. 3. Psychological models used to describe affected life domains. The role of dysfunctional thoughts on e.g. anxiety. 4. The connection between pain and factors that can reduce energy level. 5. Pain interference in the familiar dynamic and relations. 6. Information about how to balance activity and rest - and on daily breathing exercises. 7. The Rules and opportunities when health challenges working life e.g. work relocation. 8. The importance of healthy habits regarding eating, sleep, and self-treating. 9. Selection of medication according to the patient's quality of life. 10. Expected side effects of medication and on measures to counteract side effects.
干预措施: Educational Video-based Pain Program (Behavioral)
ER group
Participants will attend a single-session, 2-hour online group class. The program has two main components: didactics and skills acquisition. Participants will learn about pain self-regulation and self-management. The program content includes strategies to empower individuals with chronic non-cancer pain as following: 1) the identification of unhelpful thought patterns in the moment, 2) regulation of cognition and emotion, including thought reframing and mindset, 3) how to decrease physiological hyperarousal using relaxation techniques (binaural relaxation audio file for diaphragmatic breathing and progressive muscle relaxation), and 4) establishing self-soothing actions. At the end of the class, participants will develop a self-tailored plan for implementing these skills/strategies in daily life to use behaviors that modulate attention and counteract helplessness (Darnall et al 2014). The online class will be delivered by a nurse certified in the ER.
干预措施: Empowered Relief Program (Behavioral)
Control group
Participants in the control group will not receive any of the interventions. This project will not interfere with any current or future pain treatment. After the end of collecting data, the Multidisciplinary Pain Centre will eventually make available the videos that compose VP to all patients.
结局指标
主要结局
Change from baseline pain catastrophizing at 2, 6 and 12 months
时间窗: Baseline, 2 months, 6 months, and 12 months after the intervention
Pain catastrophizing in the last 24 hours; Pain Catastrophizing Score
次要结局
- Change from baseline health status at 2, 6 and 12 months(Baseline, 2 months, 6 months, and 12 months after the intervention)
- Change from baseline pain intensity and interference in daily activities at 2, 6 and 12 months(Baseline, 2 months, 6 months, and 12 months after the intervention)
- Change from baseline pain acceptance at 2, 6 and 12 months(Baseline, 2 months, 6 months, and 12 months after the intervention)
- Change from baseline anxiety at 2, 6 and 12 months(Baseline, 2 months, 6 months, and 12 months after the intervention)
- Change from baseline health-related quality of life at 2, 6 and 12 months(Baseline, 2 months, 6 months, and 12 months after the intervention)
- Change from baseline depression at 2, 6 and 12 months(Baseline, 2 months, 6 months, and 12 months after the intervention)
- Use of medication and health care system at 2, 6 and 12 months(2 months, 6 months, and 12 months after the intervention)
研究者
Geana P Kurita
Senior researcher
Rigshospitalet, Denmark