Clinical trial NCT04727762: Use of the Mask and Current Pandemic
Official title: Population Impact on the Continued Use of the Mask Due to the Avoidance of COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Face Mask Squeeze
Keywords: protection
SARS-CoV-2
cephalalgia
mastication
well-being
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 542
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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. 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Headache
timeFrame: 1 day
measure: Pain Temporomandibular Joint
timeFrame: 1 day
Secondary outcomes:
measure: Headache Impact
timeFrame: 1 day
measure: Influence on quality of life
timeFrame: 1 day
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Gemma Victoria Espí-López
Study officials:
affiliation: fisiotherapy
name: Gemma V Espí-López
role: PRINCIPAL_INVESTIGATOR
References: