Preoperative Mindfulness in Musculoskeletal Tumor Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Difference in State Trait Anxiety Score between Groups
研究概览
简要总结
Psychosocial distress is common in patients with an oncologic diagnosis, with anxiety being present in almost 20-30% of the patients.[1, 2, 10] Mindfulness exercises have shown to reduce this distress.[4, 5]
Recently, the implementation of a 60-second mindfulness-based intervention has shown to have momentary effects on pain, anxiety, depression and anger in orthopaedic upper extremity patients.[9] However, its lasting effect after the single intervention was not evaluated. Nonetheless, because the intervention is not time consuming and is easy to implement it may benefit orthopaedic oncology patients in their pre-operative coping.
The implementation of a 60-second mindfulness-based intervention has shown to have momentary effects on pain, anxiety, depression and anger in orthopaedic upper extremity participants. In this research study, the investigators are studying a 60-second interactive personalized acceptance-based mindfulness exercise
详细描述
The aim of this study is to evaluate the effect of a preoperative 60-second interactive personalized acceptance-based mindfulness exercise (intervention) versus a brief educational pamphlet (control) on anxiety in patients undergoing curative surgery for a musculoskeletal malignancy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult (>18 years) patients attending the Orthopaedic Oncology Department outpatient clinic (Dr. Santiago Lozano-Calderon, Dr. Kevin Raskin, Dr. J. Schwab) at the MGH with a histologically confirmed musculoskeletal malignancy undergoing curative surgery will be enrolled at their last preoperative visit.
- •Patients with a musculoskeletal malignancy undergoing curative surgical treatment
- •Histologic confirmation of malignancy prior to curative surgery
- •Primary surgery of musculoskeletal malignancy at the Massachusetts General Hospital
- •Able to give informed consent
- •English fluency and literacy
- •-- English fluency is needed because the intervention (a 60-seconds video) is in English and there is no alternate version available.
- •Age ≥18 years
- •Exclusion criteria:
- •Significant axis I or II psychopathology that would interfere with participation in the study
- •Pregnant patients
- •Metastasis at presentation
排除标准
- 未提供
结局指标
主要结局
Difference in State Trait Anxiety Score between Groups
时间窗: from enrollment to the day of admission for surgery up to 3 weeks
State-Trait Anxiety Inventory (STAI) for Adults - Form Y-1, is a measure to evaluate trait and state anxiety and helps to diagnose anxiety and to differentiate it from depressive syndromes
次要结局
- Difference in Pain Intensity Score between Groups(from enrollment to the day of admission for surgery up to 3 weeks)
- Difference in Anxiety Score between Groups(from enrollment to the day of admission for surgery up to 3 weeks)
- Difference in Depression Score between Groups(from enrollment to the day of admission for surgery up to 3 weeks)
- Difference in Distress Score between Groups(from enrollment to the day of admission for surgery up to 3 weeks)
- Difference in Anger Score between Groups(from enrollment to the day of admission for surgery up to 3 weeks)
研究者
Ana-Maria Vranceanu, PhD
Prinicipal Investigator
Massachusetts General Hospital