- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Descripción detallada
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
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: 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
|
Sin intervención: No Diary
Control Group
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Upper Extremity Disability Measured by PROMIS Upper Extremity
Periodo de tiempo: 8 weeks
|
Upper Extremity Disability measured by PROMIS Upper Extremity
|
8 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Avoidance of Painful Activities Measured by PROMIS Pain Interference
Periodo de tiempo: 8 weeks
|
Avoidance of painful activities measured by PROMIS Pain Interference
|
8 weeks
|
Symptoms of Depression Measured by PROMIS Depression
Periodo de tiempo: 8 weeks
|
Symptoms of depression measured by PROMIS Depression
|
8 weeks
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2014P002781
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Diary
-
Birmingham Women's and Children's NHS Foundation...ReclutamientoSaludable | Síntomas del tracto urinario inferiorReino Unido
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Public Health Foundation Enterprises, Inc.National Institute of Mental Health (NIMH); Emory University; San Francisco Department... y otros colaboradoresTerminadoComportamiento de riesgo | Prevención del VIH | Adherencia, Medicación | Profilaxis previa a la exposiciónEstados Unidos
-
Public Health Foundation Enterprises, Inc.National Institute of Mental Health (NIMH); Emory University; San Francisco Department... y otros colaboradoresTerminadoComportamiento de riesgo | Prevención del VIH | Adherencia, Medicación | Profilaxis previa a la exposiciónEstados Unidos