- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02361580
Impact of Keeping a Personal Recovery Diary on Upper Extremity Disability
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.
연구 개요
상세 설명
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
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 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
Exclusion Criteria:
- Pregnant women
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Diary
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.
|
Subject keeps diary of recovery
|
간섭 없음: No Diary
Control Group
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Upper Extremity Disability Measured by PROMIS Upper Extremity
기간: 8 weeks
|
Upper Extremity Disability measured by PROMIS Upper Extremity
|
8 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Avoidance of Painful Activities Measured by PROMIS Pain Interference
기간: 8 weeks
|
Avoidance of painful activities measured by PROMIS Pain Interference
|
8 weeks
|
Symptoms of Depression Measured by PROMIS Depression
기간: 8 weeks
|
Symptoms of depression measured by PROMIS Depression
|
8 weeks
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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