NCT04727762

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
542

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 27, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

February 4, 2021

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
Last Updated

August 24, 2022

Status Verified

August 1, 2022

Enrollment Period

25 days

First QC Date

January 22, 2021

Last Update Submit

August 19, 2022

Conditions

Keywords

protectionSARS-CoV-2cephalalgiamasticationwell-being

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Headache Impact

    1 day

  • Influence on quality of life

    1 day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • I do not use the mask
  • institutionalized subjects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gemma Victoria Espí-López

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Headache

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gemma V Espí-López

    fisiotherapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 22, 2021

First Posted

January 27, 2021

Study Start

February 4, 2021

Primary Completion

March 1, 2021

Study Completion

March 30, 2021

Last Updated

August 24, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations