Effectiveness of an mHealth Psychosocial Intervention to Prevent Transition From Acute to Chronic Postsurgical Pain in Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 433
- 试验地点
- 1
- 主要终点
- Post-surgical pain intensity and interference
研究概览
简要总结
This is a randomized controlled trial to test effectiveness of the SurgeryPal intervention vs. education control to improve acute and chronic pain and health outcomes in youth undergoing major musculoskeletal surgery. Youth will be randomized on an individual level using a factorial design to SurgeryPal or Education during 2 phases of intervention: 1) pre-operative phase (4 week duration delivered over the 4 weeks leading up to surgery), and 2) post-operative phase (4 week duration following surgery). Thus there will be 4 treatment arms. Participants will undergo 4 assessments, independent of their treatment assignment: T1: Baseline (pre-randomization); T2: acute post-surgery outcomes (daily assessment of acute outcomes beginning day 1 through day 14 after hospital discharge from surgery); T3: Post-surgery follow-up (assessment of outcomes at 3-months post-surgery); T4: Final post-surgery follow-up (assessment of outcomes at 6-months post-surgery).
详细描述
Major musculoskeletal surgeries are associated with particularly high prevalence of both acute and chronic post-surgical pain (CPSP), with 80% of youth reporting intense acute pain after hospital discharge, and up to half reporting CPSP up to one year after spine surgery. Interventions to improve recovery and reduce pain after surgery have potential to interrupt a negative trajectory of suffering and disability associated with chronic pain. Our specific aims are: Primary: (1) Determine effectiveness of a pre-operative mHealth psychosocial intervention to improve acute pain outcomes in adolescents undergoing major musculoskeletal surgery, (2) Determine effectiveness of a post-operative mHealth psychosocial intervention to improve chronic pain outcomes at 3 months in adolescents undergoing major musculoskeletal surgery, (3) Determine the combined effects of pre- and post-operative psychosocial intervention on chronic pain outcomes. Secondary: (1) Determine effectiveness of pre-operative psychosocial intervention to reduce opioid use during the 14 days following hospital discharge, (2) Determine effectiveness of psychosocial intervention to improve health-related quality of life following surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •12 to 18 years old at the time of enrollment
- •Undergoing scheduled spinal fusion surgery (eligible indications: juvenile/adolescent idiopathic scoliosis, congenital scoliosis, spondylolisthesis or kyphosis)
- •Parent/Caregiver
- •Parent or legal guardian of child who meets study criteria
排除标准
- •Does not speak or understand English
- •Has severe learning disability, cognitive impairment or intellectual delay (i.e. unable to read at 5th grade level)
- •Does not have access to a smart device (smartphone, iPad or tablet; Teens can borrow an iPad from the study team if one is available)
- •Recent psychiatric admission (in the past 30 days)
- •Severe systemic disease (neuromuscular scoliosis, cancer)
- •On a regular treatment regimen for a severe chronic medical condition
- •Prior major surgery (open surgery such as heart, lung, brain, abdominal surgery, or prior spine surgery)
- •Diagnosed chronic musculoskeletal pain condition (e.g. complex regional pain syndrome, fibromyalgia, widespread musculoskeletal pain)
- •Parent/Caregiver
- •Does not speak or understand English
- •Does not have access to a smart device (smartphone, iPad or tablet)
研究组 & 干预措施
Pre-operative and Post-operative Education intervention
This arm receives access to Patient Education intervention in the pre- and post-operative phases.
干预措施: Education (Behavioral)
Pre-operative CBT intervention (SurgeryPal), Post-operative Education intervention
This arm receives access to CBT intervention in the pre-operative phase and Patient Education in the post-operative phase.
干预措施: CBT (SurgeryPal) (Behavioral)
Pre-operative CBT intervention (SurgeryPal), Post-operative Education intervention
This arm receives access to CBT intervention in the pre-operative phase and Patient Education in the post-operative phase.
干预措施: Education (Behavioral)
Pre-operative Education intervention, Post-operative CBT intervention (SurgeryPal)
This arm receives access to Patient Education intervention during the pre-operative period and CBT intervention during the post-operative period.
干预措施: CBT (SurgeryPal) (Behavioral)
Pre-operative Education intervention, Post-operative CBT intervention (SurgeryPal)
This arm receives access to Patient Education intervention during the pre-operative period and CBT intervention during the post-operative period.
干预措施: Education (Behavioral)
Pre-operative and Post-operative CBT intervention (SurgeryPal)
This arm receives access to CBT intervention during the pre-operative and post-operative period.
干预措施: CBT (SurgeryPal) (Behavioral)
结局指标
主要结局
Post-surgical pain intensity and interference
时间窗: Up to 3 weeks post-surgery
The Brief Pain Inventory (BPI) has 2 scales: pain intensity (4 items) and pain interference (7 items). Items are averaged to yield scale scores, ranging from 0 to 10, with higher scores indicating greater pain intensity or interference. The 24 hour (short) version of this measure will be completed via REDCap daily for 14 days post-hospital discharge (beginning on day 1 after hospital discharge, and ending up to 3-weeks post-surgery).
Chronic pain intensity and interference
时间窗: 3 months post-surgery
The Brief Pain Inventory (BPI) has 2 scales: pain intensity (4 items) and pain interference (7 items). Items are averaged to yield scale scores, ranging from 0 to 10, with higher scores indicating greater pain intensity or interference. The 24 hour (short) version of this measure will be completed via REDCap daily for 7 days at 3 months after the participant's surgery date.
次要结局
- Change in opioid misuse(Baseline, 3-months post-surgery, 6-months post-surgery)
- Change in mental health(Baseline, 3-months post-surgery, 6-months post-surgery)
- Change in psychosocial distress(Baseline, 3-months post-surgery, 6-months post-surgery)
- Change in pain catastrophizing(Baseline, 3-months post-surgery)
- Change in sleep quality(Baseline, 3-months post-surgery, 6-months post-surgery)
- Global pain severity(Up to 3 weeks post-surgery, 3-months post-surgery, 6-months post-surgery)
- Change in health-related quality of life(Baseline, 3-months post-surgery, 6-months post-surgery)
- Change in opioid use(Baseline, Up to 3 weeks post-surgery, 3-months post-surgery, 6-months post-surgery)
研究者
Jennifer Rabbitts, MBChB
Principal Investigator, Anesthesiologist
Seattle Children's Hospital