- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04727762
Use of the Mask and Current Pandemic (Mask)
Population Impact on the Continued Use of the Mask Due to the Avoidance of COVID-19
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Introduction
Due to the continued use of the mask in order to prevent the spread of COVID-19, an impact on people is observed in different areas. The objective of our study was to collect impact aspects related to the continued use of the mask that may affect the quality of life of the population.
Material and methods
Diseny. For this, an observational study has been carried out that includes an interview with aspects related to headaches, problems in the temporomandibular joint, headache impact and quality of life.
Participants. Subjects of all ages from 18 years old will be recruited who use a mask daily for the avoidance of COVID-19 and with the ability to answer the questions and complete the questionnaires. The study will be carried out at the Faculty of Physiotherapy of the University of Valencia. The participants will sign an informed consent guaranteeing the confidentiality of the data. The study is approved by the ethics committee of our institution.
Outcomes. The sociodemographic characteristics and the use of the mask will be collected. Subsequently, the evaluation instruments without the use of a mask and with the use of the same in: Headache and the impact on headaches, pain related to temporomandibular joint and quality of life.
All data will be coded in a database and analyzed later.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Valencia, España, 46010
- Gemma Victoria Espí-López
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- from 18 years old will be recruited who use a mask daily for the avoidance of COVID-19.
- that they use the face mask at least 2 hours a day
- with the ability to answer the questions and complete the questionnaires.
Exclusion Criteria:
- I do not use the mask
- institutionalized subjects
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Headache
Periodo de tiempo: 1 day
|
An ad hoc questionnaire will be carried out that includes a question about the existence of headache before and after the use of the mask with a dichotomous response (Yes, No) and another about the frequency of headache with the options of daily, weekly or monthly.
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1 day
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Pain Temporomandibular Joint
Periodo de tiempo: 1 day
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The ad hoc questionnaire will include two questions about the existence of joint discomfort in the TMJ before and after the use of the mask with a dichotomous response (Yes, No) and pain when chewing evaluated using the Visual Analog Scale (VAS).
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1 day
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Headache Impact
Periodo de tiempo: 1 day
|
Headache Impact Test-6 (HIT-6).To measure the impact of headache.
The score is calculated as follows: never (6 points), few times (8 points), sometimes (10 points), very often (11 points) and always (13 points).
With a total of 49 or less points is considered "little or no impact", between 50-55 "some impact", between 56-59 "significant impact" and 60 or more "very severe impact".
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1 day
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Influence on quality of life
Periodo de tiempo: 1 day
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Will be measured by Cantril Ladder of Life Scale (LADER).
The Cantril Staircase (Cantril 1965), measures satisfaction with life.
The subject is asked to imagine his life in the best possible way and to describe his hopes and wishes.
You are then asked to imagine your future in the worst possible light, your fears and concerns associated with this outcome.
Subsequently, the respondent is presented with an image consisting of a ladder numbered from zero to ten, where the top of the ladder represents the best possible life for the subject = 10 and the bottom of the ladder represents the worst possible life = 0.
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1 day
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Gemma V Espí-López, fisiotherapy
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
Palabras clave
Otros números de identificación del estudio
- ID0031
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. .