- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Detaljerad beskrivning
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
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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
|
Inget ingripande: No Diary
Control Group
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Upper Extremity Disability Measured by PROMIS Upper Extremity
Tidsram: 8 weeks
|
Upper Extremity Disability measured by PROMIS Upper Extremity
|
8 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Avoidance of Painful Activities Measured by PROMIS Pain Interference
Tidsram: 8 weeks
|
Avoidance of painful activities measured by PROMIS Pain Interference
|
8 weeks
|
Symptoms of Depression Measured by PROMIS Depression
Tidsram: 8 weeks
|
Symptoms of depression measured by PROMIS Depression
|
8 weeks
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2014P002781
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