The Effects of Long-Term Mask Use in the Pandemic Period

April 28, 2022 updated by: Ankara Yildirim Beyazıt University

An Investigation of Temporomandibular Pain, Headache, and Fatigue in Relation With Long-Term Mask Use During the Pandemics

Various restrictions have been made all over the world due to coronavirus pandemics. In addition to situations such as social isolation and hygiene, the use of masks is among these rules. In addition to the protection it provides, the use of masks causes some negative situations in individuals. For this reason, the aim of our study is to examine the effects of long-term mask use on temporomandibular dysfunction, headache and fatigue.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

909

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Ankara Yildirim Beyazit University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

People using masks

Description

Inclusion Criteria:

  • Over 18 years
  • Able to read and understand
  • Volunteer to participate

Exclusion Criteria:

  • Malignity history
  • Head/Face surgery history

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
There are individuals who use masks for less than 4 hours daily.
Other: mask use
long term mask use
Group 2
There are individuals who use masks for 4-8 hours daily.
Other: mask use
long term mask use
Group 3
There are individuals who use masks for more than 8 hours daily.
Other: mask use
long term mask use

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Temporomandibular Dysfunction
Time Frame: Baseline
According to the scores obtained from the scale, 0-15 points mean no temporomandibular dysfunction symptoms, 20-45 points mean mild temporomandibular dysfunction symptoms, 50-65 points mean moderate temporomandibular dysfunction symptoms, and 70-100 severe temporomandibular dysfunction symptoms.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mask Use Symptoms
Time Frame: Baseline
It was evaluated whether long-term use of masks had negative effects such as pain, skin problems, sleep, voice problems, temporomandibular problems. The results are given in terms of frequency.
Baseline
Perceptions of Mask Use
Time Frame: Baseline
The mask discomfort perception scale was used to evaluate the uncomfortable perceptions of mask use over visual analog scale. Scores were recorded as 0- no problem, 10- many problems.
Baseline
Fatigue
Time Frame: Baseline
Fatigue was assessed with the Chalder Fatigue Scale. Each item in the scale consisting of physical and mental fatigue sub-parameters is scored between 0-3. The total score ranges from 0 to 33, and as the score increases, fatigue increases.
Baseline
Type of Headache
Time Frame: Baseline
Individuals were asked to show the localization of the headache they experienced through the presented figures.
Baseline
Trigger point of temporomandibular joint
Time Frame: Baseline
Pain intensity at the temporomandibular joint trigger points was evaluated with visual analog scale. It was recorded as 0, no pain; 10 very severe pain.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Yildirim Beyazıt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Actual)

August 31, 2021

Study Completion (Actual)

November 15, 2021

Study Registration Dates

First Submitted

April 28, 2022

First Submitted That Met QC Criteria

April 28, 2022

First Posted (Actual)

May 3, 2022

Study Record Updates

Last Update Posted (Actual)

May 3, 2022

Last Update Submitted That Met QC Criteria

April 28, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2021-586/58

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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