Postoperative Telehealth Mindfulness Intervention to Improve Pain-related Outcomes and Reduce Opioid Use After Lumbar Spine Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Acceptability - Satisfaction With Intervention
研究概览
简要总结
Lumbar spine pain is the leading cause of years lived with a disability and affects over 50 million individuals in the United States. Rates of spine surgeries performed to address degenerative spine conditions have increased markedly. A subset of patients experience poor pain, functional, or quality of life outcomes after surgery.
This study will adapt and evaluate the feasibility and potential benefits of both a one-on-one and a group-delivered, face-to-face telehealth, mindfulness intervention for patients recovering from lumbar spine surgery. The goals of the intervention are to improve short and long-term pain management, reduce the need for long-term pain medications, and improve physical and psychological well-being after surgery. The study will result in a refined intervention manual based on feasibility, participant exit interviews and satisfaction surveys which will be piloted in a future randomized controlled trial.
详细描述
We will conduct a two-arm, nonrandomized, mixed-methods trial to refine a telehealth mindfulness-based intervention (MBI) for patients recovering from spine surgery. The procedures will be as follows:
- Recruit, consent and enroll up to 26 patients over a period of 8 months who are planning to have their first lumbar spine surgery for a degenerative spine condition at the Vanderbilt Comprehensive Spine Center. Recruitment will occur at a routine preoperative clinic visit or over the phone, with the spine surgeon's permission to approach the patient.
- Two weeks after enrolled patients complete surgery, they will meet with an interventionist for eight, weekly one-on-one or group-delivered telehealth MBI sessions over a Zoom online telehealth platform. Sessions will be 75 minutes long (90 minutes for the first session). Sessions will be audio recorded and the interventionists will be supervised weekly.
- Participants will complete self-report assessments prior to surgery, two weeks after surgery (pre-intervention) and three months after surgery (post-intervention).
- After completing the intervention, participants will complete an intervention satisfaction survey and an audio-recorded 30-minute semi-structured interview over the phone to provide feedback regarding their experience with the intervention components and relevance to their postoperative recovery.
- We will code and analyze interview data continuously (every 2-4 interviews) until we reach data saturation and then integrate results from interviews and self-report surveys to determine relevant intervention adaptations, constructing a refined intervention protocol for pilot testing in a randomized controlled trial. We anticipate needing approximately 13-20 participants to complete interviews to reach data saturation (i.e. no new, relevant information obtained from interviews).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English-speaking adults
- •Between the ages of 18 and 90
- •Scheduled for a laminectomy and/or fusion at Vanderbilt Spine Center
- •Scheduled for their first lumbar spine surgery
- •Radiographic evidence of a degenerative condition including but not limited to spinal stenosis, spondylosis with or without myelopathy, and spondylolisthesis
- •Presence of back and/or lower extremity pain persisting for at least 3 months
- •Access to stable internet.
- •Able to participate in weekly, remote sessions with a study therapist for 8 weeks after surgery
排除标准
- •Microsurgical technique as the primary procedure (i.e. isolated laminotomy or microdiscectomy)
- •Having surgery for the primary indication of a spinal deformity
- •Having surgery secondary to pseudarthrosis, trauma, infection, or tumor
- •Current/history of a primary psychotic or major thought disorder or hospitalization for reasons related to psychosis
- •Diagnosis of Alzheimer's disease or another form of dementia
- •Traumatic Brain Injury (greater than mild severity)
- •History of bipolar disorder or dissociative disorder
- •Active substance use disorder (in past month)
- •Current Posttraumatic Stress Disorder (PTSD) symptoms (in past month)
研究组 & 干预措施
Individual telehealth mindfulness
Telehealth mindfulness sessions delivered one-on-one with mindfulness therapist
干预措施: Individual telehealth mindfulness (Behavioral)
Group Telehealth Mindfulness
Telehealth mindfulness sessions delivered in a small-group format with mindfulness therapist
干预措施: Group telehealth mindfulness (Behavioral)
结局指标
主要结局
Acceptability - Satisfaction With Intervention
时间窗: 3 months following lumbar spine surgery
Nine items assessing satisfaction with the postsurgical telehealth mindfulness intervention (sum of item scores; higher scores indicate higher satisfaction; scores can range from 7 to 55)
Feasibility - Session Attendance
时间窗: 3 months following lumbar spine surgery
Percent of sessions attended out of 8
Feasibility - Study Retention
时间窗: 3 months following lumbar spine surgery
Percentage of participants enrolled who complete the study
次要结局
- Depression Short Form 4a(3 months postoperative)
- Pain Self-efficacy Questionnaire(3 months postoperative)
- Pain Bothersomeness(3 months postoperative)
- Perceived Stress Scale - 4(3 months postoperative)
- Five Facet Mindfulness Questionnaire - 15(3 months postoperative)
- Back and Leg Pain Intensity(3 months postoperative)
- Pain Interference Short-form 4a(3 months postoperative)
- Overall Pain Intensity(3 months postoperative)
- Self-reported Opioid Medication Use(3 months postoperative)
- Anxiety Short Form 4a(3 months postoperative)
- Tampa Scale for Kinesiophobia -13(3 months postoperative)
- Oswestry Disability Index(3 months postoperative)
- Pain Catastrophizing Scale(3 months postoperative)
研究者
Carrie Brintz
Assistant Professor
Vanderbilt University Medical Center