Effects of a Peri-operative Brief Mindfulness-based Intervention on Post-operative Pain and Disability Among Anxious Patients With Chronic Pain Undergoing Total Hip Arthroplasty - a Feasibility and Acceptability Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in pain-related disability, as measured by the Brief Pain Inventory - Pain Interference scale, at approximately 48 hours post-surgery.
研究概览
简要总结
This study evaluates the effectiveness of a brief mindfulness-based intervention on post-operative pain and disability among anxious patients with chronic pain undergoing total hip arthroplasty.
All participants will receive an educational brochure and links to videos containing strategies for coping with pain and anxiety. The half of the participants who are allocated to the treatment arm will also receive a 10 minute mindfulness intervention called a body scan.
详细描述
Psychological distress or anxiety is common in patients awaiting surgical procedures and can have impact on both physical and mental health, leading to significantly reduced quality of life. It has been associated with a slower and more complicated postoperative recovery and has been established as an independent predictor of pain and pain related outcomes after surgery.
Pharmacological interventions and provision of information about surgical processes are two ways that pre-operative anxiety is currently addressed. Mindfulness-based interventions have shown positive results in reducing psychological distress and improving pain related outcomes and may be a promising treatment avenue to evaluate in a surgical population.
With the goal of conducting a full-scale definitive trial to investigate the effectiveness of a brief mindfulness-based intervention on post-operative pain and disability among anxious patients with chronic pain undergoing total hip arthroplasty, this pilot study has been developed to demonstrate proof of concept, test/refine the intervention, recruitment, and data collection procedures, and test the intervention's acceptability in the peri-operative setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Adult (age 18+) patients presenting at the Pre-Admission Unit (PAU) at the General campus of The Ottawa Hospital (TOH) for total hip arthroplasty (THA)
- •History of pain for ≥3 months (chronic pain)
- •Anxiety scores of ≥8 on the Generalized Anxiety Disorder 7-item (GAD-7) scale
- •Ability to understand oral and written English or French
排除标准
- •Refusal or inability to provide consent
- •Severe depressive symptoms as indicated by score ≥ 20 on the Patient Health Questionnaire (PHQ-9) scale
- •Prior mindfulness training experience
- •Pre-planned same day discharge after surgery
结局指标
主要结局
Change in pain-related disability, as measured by the Brief Pain Inventory - Pain Interference scale, at approximately 48 hours post-surgery.
时间窗: Within 4 hours before surgery and approximately 48 hours after transfer from recovery to the orthopedic floor
The primary outcome will be the mean score of the Brief Pain Inventory (BPI) Interference Scale 48 hours post-surgery. The interference scale measures the degree to which pain interferes in the lives of participants in 7 domains: general activity, mood, walking ability, normal work, relations with other persons, sleep and enjoyment of life on a scale from 0 to 10. The higher the score, the greater the pain interferes with patient's activities.
次要结局
- Change in pain catastrophizing, as measured by the Pain Catastrophizing Scale(Within 4 hours before surgery and approximately 48 hours after transfer from recovery to the orthopedic floor.)
- Change in pain intensity, as measured by the Brief Pain Inventory.(Within 4 hours before surgery and approximately 48 hours after transfer from recovery to the orthopedic floor.)
- Change in quality of life, as measured by the EuroQOL-5D(Within 4 hours before surgery and approximately 48 hours after transfer from recovery to the orthopedic floor.)
- Change in mindfulness, as measured by the Short Form Five Facet Mindfulness Questionnaire.(Within 4 hours before surgery and approximately 48 hours after transfer from recovery to the orthopedic floor.)