Fatiga en el Síndrome de Sjögren Primario
El nivel de fatiga y su relación con la actividad de la enfermedad, el dolor, el insomnio y los parámetros psicométricos en el síndrome de Sjögren primario
Fatigue is a common clinical finding in Primary Sjögren's syndrome (PSS). In PSS, there is not enough data about the conditions in which fatigue develops and which clinical conditions the disease is associated with. This study was aimed to determine the level of fatigue in Primary Sjögren syndrome and to investigate the factors affecting the level of fatigue.
Descripción general del estudio
Estado
Descripción detallada
While fatigue is seen with a prevalence of 7-8% in the normal population, it is more prevalent in Primary Sjögren's syndrome (PSS). In the studies conducted so far, the frequency of fatigue was seen at a frequency of over 30% in Primary Sjögren's syndrome. Although fatigue is so common in PSS, there is not enough data about the conditions in which fatigue develops in PSS. Other common conditions in PSS, apart from fatigue, are psychometric disorders such as common pain, depression and anxiety, and sleep disorders. In the studies conducted so far, each situation mentioned is common in PSS and seems to be related to each other. In the literature, there is no data on how many psychometric parameters, pain level, and insomnia affect fatigue and which are independent risk factors in PSS.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Bursa
-
Yıldırım, Bursa, Turquía (Türkiye), 16310
- Koray Ayar
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Volunteers who were followed up with a diagnosis of PSS in the center where the study was conducted and met the inclusion and exclusion criteria.
Descripción
Inclusion Criteria:
- Patients diagnosed with PSS according to the 2016 ACR / EULAR criteria
- Healthy hospital staff
Exclusion Criteria:
- Pregnant women
- Cancer patients
- Those with other connective tissue diseases other than PSS
- Multiple sclerosis patients
- Chronic obstructive pulmonary disease
- Those with heart failure and adrenal insufficiency
- Those with renal failure: GFR <60 ml/min
- Anemia: Hemoglobin <11 g / dl in women, hemoglobin <12 g / dl in men
- Hypothyroidism: TSH >5 mu / L
- Those with electrolyte disturbance
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: CASE_CONTROL
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Primary Sjögren's syndrome
The patient's diagnosed with Primary Sjögren's according to 2016 ACR/EULAR classification criteria |
The questionnaire, based on patient report outcome data in which the presence of fatique is investigated in participants. The questionnaire, based on patient report outcome data in which the presence of depression is investigated in participants. The questionnaire, based on patient report outcome data in which the presence of anxiety is investigated in participants. The questionnaire, based on patient report outcome data in which the presence of insomnia is investigated in participants. The questionnaire, based on patient report outcome data in which the severity of Sjögren's syndrome is investigated in participants. Activity scale in which the activity of Sjögren's syndrome is evaluated based on the laboratory and imaging tests of the patients and the examination findings of the evaluator. The questionnaire, based on patient report outcome data in which the severity and extent of pain in the body are investigated in participants. |
|
Healthy Controls
Healthy hospital workers without any chronic disease |
The questionnaire, based on patient report outcome data in which the presence of fatique is investigated in participants. The questionnaire, based on patient report outcome data in which the presence of depression is investigated in participants. The questionnaire, based on patient report outcome data in which the presence of anxiety is investigated in participants. The questionnaire, based on patient report outcome data in which the presence of insomnia is investigated in participants. The questionnaire, based on patient report outcome data in which the severity and extent of pain in the body are investigated in participants. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
FACIT-F
Periodo de tiempo: day 1
|
FUNCTIONAL ASSESSMENT OF CHRONIC ILLNESS THERAPY-FATİQUE |
day 1
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
BDI
Periodo de tiempo: day 1
|
Beck Depression Inventory |
day 1
|
|
BAI
Periodo de tiempo: day 1
|
Beck Anxiety Inventory |
day 1
|
|
ISS
Periodo de tiempo: day 1
|
Insomnia Severity Scale |
day 1
|
|
PDQ
Periodo de tiempo: day 1
|
Pain Detect Questionnaire |
day 1
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Koray Ayar, M.D., Univesity of Health Science, Bursa Yuksek Ihtisas Training and Research Hospital
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 (Actual)
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
- Enfermedades musculoesqueléticas
- Enfermedades de la Boca
- Enfermedades Estomatognáticas
- Enfermedades del Sistema Nervioso
- Enfermedades Musculares
- Desordenes mentales
- Enfermedades Neuromusculares
- Artritis
- Enfermedades Articulares
- Enfermedades reumáticas
- Enfermedades del tejido conectivo
- Enfermedades autoinmunes
- Enfermedades del sistema inmunológico
- Síntomas de comportamiento
- Enfermedades de los ojos
- Artritis Reumatoide
- Xerostomía
- Enfermedades de las glándulas salivales
- Síndromes del ojo seco
- Enfermedades del aparato lagrimal
- Condiciones Patológicas, Signos y Síntomas
- Comportamiento
- Enfermedades de la piel y del tejido conectivo
- Signos y síntomas
- Trastornos somatomorfos
- Desórdenes de ansiedad
- Fibromialgia
- Depresión
- Fatiga
- Síndrome de Sjogren
Otros números de identificación del estudio
- 2011-KAEK-25 2020/12-10
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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. .