- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
-
Valencia, Espagne, 46010
- Gemma Victoria Espí-López
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Headache
Délai: 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.
|
1 day
|
|
Pain Temporomandibular Joint
Délai: 1 day
|
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).
|
1 day
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Headache Impact
Délai: 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".
|
1 day
|
|
Influence on quality of life
Délai: 1 day
|
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.
|
1 day
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Gemma V Espí-López, fisiotherapy
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- ID0031
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .