Perioperative Cognitive Flexibility Training for the Prevention of Persistent Pain After Thoracic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- The presence of clinically meaningful persistent post-surgical pain 3 months after surgery
研究概览
简要总结
More than 30% of patients undergoing thoracic surgical procedures develop persistent post-surgical pain (PPSP), which results in impaired functioning, diminished quality of life, and increased risk of chronic opioid use. The proposed project aims to determine whether a prospective, randomized, controlled study of smartphone-based perioperative cognitive flexibility training will reduce the incidence of PPSP in high-risk individuals undergoing thoracic surgery.
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 (Care Provider, Investigator, Outcomes Assessor)
盲法说明
All study team members will be blinded to the subject assignment to either intervention (cognitive flexibility training) or control groups (crossword puzzle training), except one coordinator who will monitor participant adherence with the cognitive flexibility training, and send prompts or contact participants to understand barriers to adherence.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults age 18 to 75 undergoing thoracic surgery
- •Access to an active email account
- •Score <50th percentile on Color Word Matching Stroop Test (CWMST) normalized T-score
排除标准
- •Unable to complete cognitive testing
- •Color blindness assessed via self-report
- •Participants who do not speak or read English
- •The inclusion criteria for the observational cohort will be the same, with the exception of Score ≥50th percentile on Color Word Matching Stroop Test (CWMST) normalized T-score.
结局指标
主要结局
The presence of clinically meaningful persistent post-surgical pain 3 months after surgery
时间窗: 3 months after surgery
Participants will be asked about pain at or around their surgical area (dichotomous yes/no answer), and rate the intensity of pain, if present, on 0-10 numerical rating scale, where 0=no pain, and 10=worst imaginable pain. The presence of PPSP will be compared between the intervention arm and the control arm
次要结局
- PROMIS Anxiety Score(3 months after surgery)
- PROMIS Depression score(3 months after surgery)
- Brief Pain Inventory pain interference(1 and 3 months after surgery)
- Brief Pain Inventory pain severity(1 and 3 months after surgery)