The Influence of Mindfulness on Patient-Reported Outcomes, Return to Sport and Re-Injury Following Anterior Cruciate Ligament (ACL) Reconstruction Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Change in PROMIS Global Health Questionnaire (GHQ) Score
研究概览
简要总结
Anterior cruciate ligament (ACL) surgery patients experience physical trauma, both in the physical injury itself and following surgery, and face potential long-lasting adverse effects such as muscle weakness, diminished joint function, hip pain, and fear. Many of these patients report more significant anxiety and depression following surgery, which can further compound these patients' adverse outcomes. 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 (PROs) following ACL reconstruction surgery.
详细描述
Rationale and Approach: ACL reconstruction surgery patients experience physical trauma, both in the physical injury itself and following surgery, and face potential adverse long-lasting effects such as muscle weakness, arthritis, persistent knee pain, anxiety, depression, post-traumatic stress, and fear of re-injury. Many of these patients report sufficient psychological trauma that undermines a return to sport and potentially contributes to the risk of re-injury to the repaired knee. 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 ACL reconstruction surgery.
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Specific Aim 1: To determine the influence of mindfulness training on patient-reported outcomes and return to sport following ACL reconstruction surgery
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Hypothesis 1: Mindfulness training will be associated with improvements in pain, quality of life, depression, anxiety, post-traumatic stress and fear of re-injury, as well as greater likelihood of returning to sport in the 24 months following ACL reconstruction surgery
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Specific Aim 2: To determine the influence of mindfulness training on re-injury risk following ACL reconstruction surgery
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Hypothesis 2: Among those participants that return to sport, mindfulness training will be associated with a decreased risk of ipsilateral ACL rupture in the 24 months following ACL reconstruction surgery
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Specific Aim 3: To determine the factors that influence mindfulness efficacy in patient-reported outcomes and return to sport following ACL reconstruction surgery
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Hypothesis 3: Among participants in the mindfulness group, total duration of mindfulness training and female gender will be independently associated with improvements in pain, quality of life, depression, anxiety, post-traumatic stress and fear of re-injury, as well as greater likelihood of returning to sport in the 24 months following ACL reconstruction 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
- 16 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •16-40 years old at the time of the pre-operative visit
- •Regular access to a mobile device compatible with the Healthy Minds Program (HMP) App (Android or iOS)
- •Undergoing ACL surgery
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
- •Knee injury requiring multi-ligament reconstruction
- •Prior ipsilateral knee surgery
- •Prior contralateral ACL reconstruction
研究组 & 干预措施
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)
Standard of Care
Control group receives standard of care only
结局指标
主要结局
Change in PROMIS Global Health Questionnaire (GHQ) Score
时间窗: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
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 Horowitz Impact of Events Scale Score
时间窗: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Post-traumatic stress is assessed via a 15-item survey scored from 0-3 where higher scores indicate greater level of post-traumatic stress.
Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Score
时间窗: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Knee function is assessed via a 10-item survey scored from 0-10 where higher scores means less limitation with activities and less symptoms.
Change in PROMIS Depression Questionnaire Score
时间窗: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Depression will be assessed via an 8-item questionnaire scored from 0-5 where higher scores represents greater depression.
Change in Pain Catastrophizing Scale (PCS) Score
时间窗: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Pain catastrophizing is assessed via a 13-item survey scored from 0-4 where higher scores indicate a higher level of pain catastrophizing.
Change in PROMIS Anxiety Questionnaire Score
时间窗: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Anxiety will be assessed via an 8-item questionnaire scored from 0-5 where higher scores represents greater anxiety.
Change in Athletic Identity Measurement Scale (AIMS) Score
时间窗: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Athletic identity is assessed via a 10-item survey with a total range of scores from 10-70 where higher scores indicate a higher level of athletic identity.
Change in General physical activity questionnaire (GPAQ) Measured as Minutes of Total Physical Activity per day
时间窗: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Higher score indicates higher physical activity.
Change in Single Assessment Numeric Evaluation (SANE) Score
时间窗: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Pain severity is assessed via a single item survey scored from 0-100 where a higher score indicates greater pain.
Change in Tampa Scale of Kinesiophobia 11 (TSK-11) Score
时间窗: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Fear of re-injury is assessed via an 11-item survey scored from 1-4 where higher scores indicate a greater fear of re-injury.
Change in Anterior Cruciate Ligament Return to Sport After Injury scale (ACL-RSI) Score
时间窗: baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months post surgery
Psychological readiness is assessed via a 12-item survey scored on an 11-point scale where higher scores indicate a higher level of readiness.
次要结局
- Knee Range of Motion(6 weeks, 3 months, 6 months, 12 months, 24 months post surgery)
- Change in Jump Landing Assessment: Force Measures(6 weeks, 3 months, 6 months, 12 months, 24 months post surgery)
- Total Duration of Mindfulness Intervention in the Mindfulness Group(up to 24 months)
- Number of Participants Who Return to Sport(up to 24 months)
- Change in Vertical Hop Testing: Force Measures(6 weeks, 3 months, 6 months, 12 months, 24 months post surgery)
- Change in Jump Height(6 weeks, 3 months, 6 months, 12 months, 24 months post surgery)
- Peak Torque(6 weeks, 3 months, 6 months, 12 months, 24 months post surgery)
- Hamstring to Quadriceps Torque Ratio(6 weeks, 3 months, 6 months, 12 months, 24 months post surgery)
- Peak Torque Relative to Body Weight(6 weeks, 3 months, 6 months, 12 months, 24 months post surgery)
- Change in Hop Height(6 weeks, 3 months, 6 months, 12 months, 24 months post surgery)