Use of the Mask and Current Pandemic (Mask)

Population Impact on the Continued Use of the Mask Due to the Avoidance of COVID-19

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.

Study Overview

• Status: Completed
• Conditions: Face Mask Squeeze

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.

• Study Type: Observational
• Enrollment (Actual): 542

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46010
    • Gemma Victoria Espí-López

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Headache	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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Headache Impact	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	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

Collaborators and Investigators

• Sponsor: University of Valencia
• Investigators: Principal Investigator: Gemma V Espí-López, fisiotherapy

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2021
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): March 30, 2021

Study Registration Dates

• First Submitted: January 22, 2021
• First Submitted That Met QC Criteria: January 22, 2021
• First Posted (Actual): January 27, 2021

Study Record Updates

• Last Update Posted (Actual): August 24, 2022
• Last Update Submitted That Met QC Criteria: August 19, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: SARS-CoV-2; well-being; mastication; protection; cephalalgia
• Other Study ID Numbers: ID0031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No