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

Sponsor
Ankara Yildirim Beyazıt University (Other)
Overall Status
Completed
CT.gov ID
NCT05358665
Collaborator
(none)
909
1
6.5
139.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: mask use

Study Design

Study Type:
Observational
Actual Enrollment :
909 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
An Investigation of Temporomandibular Pain, Headache, and Fatigue in Relation With Long-Term Mask Use During the Pandemics
Actual Study Start Date :
May 1, 2021
Actual Primary Completion Date :
Aug 31, 2021
Actual Study Completion Date :
Nov 15, 2021

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Temporomandibular Dysfunction [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.

Secondary Outcome Measures

  1. Mask Use Symptoms [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.

  2. Perceptions of Mask Use [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.

  3. Fatigue [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.

  4. Type of Headache [Baseline]

    Individuals were asked to show the localization of the headache they experienced through the presented figures.

  5. Trigger point of temporomandibular joint [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Over 18 years

  • Able to read and understand

  • Volunteer to participate

Exclusion Criteria:
  • Malignity history

  • Head/Face surgery history

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ankara Yildirim Beyazit University Ankara Turkey

Sponsors and Collaborators

  • Ankara Yildirim Beyazıt University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ankara Yildirim Beyazıt University
ClinicalTrials.gov Identifier:
NCT05358665
Other Study ID Numbers:
  • 2021-586/58
First Posted:
May 3, 2022
Last Update Posted:
May 3, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ankara Yildirim Beyazıt University

Study Results

No Results Posted as of May 3, 2022