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临床试验/NCT02361580
NCT02361580终止不适用

Impact of Keeping a Personal Recovery Diary on Upper Extremity Disability

Massachusetts General Hospital0 个研究点目标入组 9 人开始时间: 2015年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
9
主要终点
Upper Extremity Disability Measured by PROMIS Upper Extremity

研究概览

简要总结

Primary null hypothesis:

• Keeping a personal diary has no effect on upper-extremity disability (assessed w/ PROMIS [Patient Reported Outcome Measurement Information System] upper extremity) 8 weeks after injury.

Secondary null hypotheses:

  • Keeping a personal diary has no effect on avoidance of painful activities (assessed w/ PROMIS pain interference) 8 weeks after injury.
  • Keeping a personal diary has no effect on symptoms of depression (assessed w/ PROMIS depression) 8 weeks after injury.
  • There are no factors associated with upper-extremity disability 8 weeks after injury.

详细描述

Recovery from injury can be counterintuitive and taxing. It is natural to feel protective and prepare for the worst. Healthy exercises can seem unwise. It can seem like things are taking too long or getting off track. We have noticed that small improvements such as being able to resume a cherished activity (e.g. knitting or swimming) or achieving some success with exercises (e.g. obtaining full supination after fracture of the distal radius), can help patients feel like things are going to be okay. That feeling seems to make it easier to do exercises and resume function activities.

We wonder if awareness of this process (mindfulness) would help patients recover more rapidly. Keeping a journal is one method for encouraging mindfulness. It allows patients to express themselves and tell their stories. There is evidence that such "narrative medicine" can be healing. We anticipate that patients who perceive little or no progress will be able to look back on how they were feeling earlier on and appreciate that things are moving in the right direction. We also hope that their journal material might be useful for other patients that are having trouble seeing the "light at the end of the tunnel", so as part of this study, we will get permission to use their quotes anonymously in future patient care materials and future research. To our knowledge, research on the impact of keeping a personal diary/journal of recovery is scant, particularly pertaining to recovery from upper extremity trauma.

Explanatory variables:

  • Diary or no Diary
  • Diagnosis (fracture, sprain, contusion, skin laceration, complex laceration [tendon, nerve])
  • Location (hand, wrist, forearm, elbow, arm, shoulder)
  • Sex
  • Age
  • Education
  • Work status
  • Insurance (worker's compensation, private, public, other)
  • Visit type
  • Prior treatment received
  • Other pain conditions
  • Smoking status
  • Marital status
  • Physical or Occupational Therapy

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
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 new patients (>18 years) with an acute injury of the upper extremity (fracture, laceration, sprain, contusion)
  • •English fluency and literacy
  • •Able to take informed consent

排除标准

  • •Pregnant women

研究组 & 干预措施

Diary

Experimental

Subjects that are randomized to the diary group will be told to keep a diary of their recovery. The study is focusing on the effect of keeping a diary on disability, rather than the content of the diary.

干预措施: Diary (Other)

No Diary

No Intervention

Control Group

结局指标

主要结局

Upper Extremity Disability Measured by PROMIS Upper Extremity

时间窗: 8 weeks

Upper Extremity Disability measured by PROMIS Upper Extremity

次要结局

  • Avoidance of Painful Activities Measured by PROMIS Pain Interference(8 weeks)
  • Symptoms of Depression Measured by PROMIS Depression(8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David C. Ring, MD

Chief of Hand and Upper Extremity Service

Massachusetts General Hospital

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