The Study of the Relationship of Insomnia in the Traditional Chinese Medicine and Western Medicine at Local Clinic
23 de mayo de 2017 actualizado por: Ching-Liang Hsieh, China Medical University Hospital
Insomnia is one of the most main diseases of civilization in the world, which chronic insomnia is up to 30% in Taiwan under the latest statistics and a common disease which appears to sleep difficultly, sleep interrupted, wake up early or wake up still tired. Long-term persistence of these symptoms will lead to the occurrence of mental illness and then affect people's emotional behavior and cognitive memory, showing that insomnia is an important modern health issues. Recently, "individual response patterns" was proposed by modern medicine. This thinking process and spirit seems to be compatible with the traditional Chinese medicine (TCM) therapy of "Differential Treatment". The purpose of this study, the Athens Insomnia Scale (AIS), commonly used to quickly screen for insomnia patients and the evaluation of Western medicine efficacy in Western medicine clinic, and investigation of Syndrome Type of TCM to find out whether with Syndrome Type of TCM and AIS in the associated factors, and confirm the necessity and importance of Syndrome Type of TCM, for future reference and basis for the development of integrated medicine.
In the cross-section study with an interview on survey, sampling Miaoli County an Chinese medicine clinic, in line with standard sampling of 200 patients with insomnia were recruited. The questionnaires contained two instruments including Athens Insomnia Scale (AIS), and Syndrome Type of TCM questionnaire. Cross-table, chi-square test, variance analysis and Pearson product-moment correlation was used to find the relation.
Descripción general del estudio
Estado
Estado
Desconocido
Condiciones
Condiciones
Descripción detallada
Insomnia is a common sleep disturbance, there were more than a quarter of people with sleep disorders, the prevalence with more and higher, seriously affecting the health and quality of life.
The Athens Insomnia Scale (referred to as AIS) can help physicians more accurately diagnose and understand the state of insomnia patients.
The purpose of this study was investigated the correlation among the disease status, treatment and AIS assessment, hoping enough traditional Chinese physician and Western physician's clinical reference.
Methods: This study used the cross-sectional questionnaire survey with the convenience sampling method.
Screened 200 patients according to the diagnostic criteria for insomnia and conducted a survey from the local clinic at Miaoli County.
Tipo de estudio
Tipo de estudio
De observación
Inscripción (Anticipado)
Inscripción
200
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
Estudio Contacto
- Nombre: Shin-Huey Tseng
- Número de teléfono: +886-956272668
- Correo electrónico: u105043001@cmu.edu.tw
Ubicaciones de estudio
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Miaoli County, Taiwán, 350
- Reclutamiento
- Zhunan Ho-Te Chinese medicine clinic
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Contacto:
- Shin-Huey Tseng
- Número de teléfono: 886-956272668
- Correo electrónico: u105043001@cmu.edu.tw
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
20 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
an Chinese medicine clinic at Miaoli County
Descripción
Inclusion Criteria:
- Compliance with the International Statistical Classification of Diseases and Related Health Problems (ICD)-10 and the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV and other international standards in the diagnosis of non-organic insomnia criteria to determine the main diagnosis and secondary diagnosis of insomnia: A. Complaint of difficulty initiating sleep, difficulty maintaining sleep, or waking up too early, or sleep that is chronically nonrestorative or poor in quality. B. Any sleep difficulty at least three times a week and during the period of the last month. C. Over concerns or worries about sleep. D. The night time sleep difficulty is related to daytime impairment: mood disturbance or social and vocational dysfunction
- Cooperation with physician voluntarily, communication with physician normally
Exclusion Criteria:
- Teenagers and babies
- Insomnia associated with other sleep disorders most commonly includes sleep related breathing disorders (e.g.,obstructive sleep apnea), movement disorders (e.g.,restless legs or periodic limb movements during sleep) or circadian rhythm sleep disorders;
- Insomnia due to medical or psychiatric disorders (Schizophrenia, paranoia, affective psychosis, bipolar disorder, depression, organic psychosis like brain injury, epilepsy, dementia and so on), or to drug/substance (comorbid insomnia); and
- Primary insomnias including psychophysiological, idiopathic, and paradoxical insomnias.
- Lack of intelligence or other reasons it is difficult to correctly fill the questionnaire
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Número de grupos/cohortes
1
Cohortes e Intervenciones
Grupo / CohorteGrupo / Cohorte |
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Insomnia
those with unsatisfactory sleep quantity and/or quality (difficulty with sleep induction, awakenings during the night, early morning awakening, total sleep time, and overall quality of sleep), complaint of a minimum frequency (at least three times a week) and duration (1 month), marked distress caused by the sleep problem and/or interference with ordinary activities of daily living
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Questionnaires and Data analysis
Periodo de tiempo: Patients were estimated any sleep difficulty during the period of last 4 weeks and then finished record about 15-20 minutes. A copy was done after 2 weeks. From date of randomization until the date of final documented progression, assessed 2 months.
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Scores for each sleep dimension on the AIS questionnaire compared to Syndrome Type of TCM questionnaire.
The AIS questionnaire contains 8 items which are rated on 0-3 scale ("0" means "no problem", "1" means "mild problem", "2" means "marked problem", "3" means "severe problem").
For each dimension, item scores are coded, summed, and transformed on to a scale from 0 (best sleep) to 24 (worst sleep) as an individual's sleep outcome.
Syndrome Type of TCM questionnaire contains 6 patterns: pattern of yin deficiency with effulgent fire, pattern of deficiency of both heart and spleen, pattern of liver depression transforming into fire, pattern of phlegm-heat harassing internally, pattern of heart and gallbladder qi insufficiency, the other patterns as well and case numbers are counted as an TCM pattern's outcome.
Finally, study the distribution law of insomnia's TCM pattern identification and relative factors of AIS.
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Patients were estimated any sleep difficulty during the period of last 4 weeks and then finished record about 15-20 minutes. A copy was done after 2 weeks. From date of randomization until the date of final documented progression, assessed 2 months.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: Ching-Liang Hsieh, China Medical University Hospital
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
19 de mayo de 2017
Finalización primaria (Anticipado)
Finalización primaria
4 de mayo de 2018
Finalización del estudio (Anticipado)
Finalización del estudio
4 de mayo de 2018
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
18 de mayo de 2017
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
23 de mayo de 2017
Publicado por primera vez (Actual)
Publicado por primera vez
24 de mayo de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
24 de mayo de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
23 de mayo de 2017
Última verificación
Última verificación
1 de mayo de 2017
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- CRREC-106-028
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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