The Influence of Mindfulness on Patient-Reported Outcomes Following Hip Preservation Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Change in International Hip Outcome Tool (IHOT) Score
研究概览
简要总结
Hip preservation surgery patients experience physical trauma, both in the physical injury itself and following surgery, and face potential long-lasting effects such as muscle weakness or diminished joint function, hip pain, and fear. Many of these patients report greater anxiety and depression following surgery, which can further compound negative outcomes in these patients. This study is a single-blind, randomized controlled trial design to evaluate the effects of a remotely-delivered 8-week mindfulness intervention on patient-reported outcomes following hip preservation surgery.
详细描述
The goal is to identify whether a mobile-based daily mindfulness program for the immediate eight weeks following hip preservation surgery improves outcomes in patients. The investigators hypothesize that patients who participate in a mindfulness intervention will have less pain, better hip function, greater quality of life, and improved scores on standardized patient reported outcome measures for 24 months following surgery.
The investigators expect their findings will re-direct post-operative strategies beyond the physical recovery in orthopedic surgery patients and improve long-term outcomes. To test the overall hypothesis and contribute significantly to understanding of the impact of a psychosocial intervention on outcomes in orthopedic surgery patients, the specific aim is to determine the influence of mindfulness training on patient-reported outcomes following hip preservation surgery.
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Specific Aim 1: To determine the influence of mindfulness training on patient-reported outcomes following hip preservation surgery
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Hypothesis 1: Mindfulness training will be associated with improvements in pain, post-operative opiate use, hip function, quality of life and improved scores on standardized patient reported outcome measures for 24 months following hip preservation surgery
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Specific Aim 2: To determine the factors that influence mindfulness efficacy in patient-reported outcomes following hip preservation surgery
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Hypothesis 2: Among participants in the mindfulness group, total duration of mindfulness training, female gender, and higher education level will be independently and positively associated with improvements in pain, hip function, and quality of life for 24 months following hip preservation surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
All healthcare providers involved in the care of the participant following surgery (surgeon, physician's assistants, nurses, medical assistants, etc.) will be blinded to the group assignment of each participant.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-45 years old at the time of the pre-operative visit
- •Access to a mobile device compatible with the freely available Healthy Minds Program (HMP) App (Android or iOS)
- •Participation in study 2019-0363
排除标准
- •Prior diagnosis of serious mental illness (schizophrenia, bipolar disorder, schizoaffective disorder, etc).
- •Significant prior experience with meditation or mindfulness, defined as greater than 30 minutes in a month during the past year
研究组 & 干预措施
Standard of Care
Control group receives standard of care only
Mindfulness Intervention plus Standard of Care
The Foundations and Awareness modules of the HMP app require a minimum of 133 and 253 minutes, equating to less than 5 and less than 10 minutes per day on average, respectively. Date, duration, and content of usage will be recorded for each participant through the app. Participants will have access to the entire contents of the app for the full duration of the study.
干预措施: Healthy Minds Program (HMP) App (Behavioral)
结局指标
主要结局
Change in International Hip Outcome Tool (IHOT) Score
时间窗: baseline, 3 months, 6 months, 12 months, 24 months
Hip-related QoL is assessed via a 12-item survey scored from 0-10 where higher scores represent better hip-related quality of life.
Change in PROMIS Anxiety and Depression Questionnaire Score
时间窗: baseline, 3 months, 6 months, 12 months, 24 months
Anxiety and depression will be assessed via an 8-item questionnaire scored from 0-5 where higher scores represents greater anxiety and depression.
Change in Hip Outcome Score (HOS-ADL and HOS-SS)
时间窗: baseline, 3 months, 6 months, 12 months, 24 months
Function with Activities of Daily Living and Sport Specific activities are assessed via a 28-items scored from 0-4 where higher scores indicate improved function.
Change in Modified Harris Hip Score (mHHS)
时间窗: baseline, 3 months, 6 months, 12 months, 24 months
Hip function is assessed via an 8-item survey scored on various scales with a total possible range of scores from 0-91 where higher scores indicate better hip pain and function.
Change in PROMIS Global Health Questionnaire (GHQ) Score
时间窗: baseline, 3 months, 6 months, 12 months, 24 months
Global quality of life (QoL) will be assessed via a 9-item questionnaire scored on a 0-100 scale where higher scores indicate better QoL, pain interference, and fatigue.
Change in Single Assessment Numeric Evaluation (SANE) Score
时间窗: baseline, 3 months, 6 months, 12 months, 24 months
Current illness is assessed via a single item survey scored from 0-100 where a higher score represents closer to uninjured baseline.
次要结局
- Total Duration of Mindfulness Training in the Mindfulness Group(up to 24 months)