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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05358665
• Other study ID #: 2021-586/58
• Status: Completed
• Start date: May 1, 2021
• Est. completion date: November 15, 2021

Study information

• Verified date: April 2022
• Source: Ankara Yildirim Beyazit University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 909
• Est. completion date: November 15, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over 18 years

• Able to read and understand

• Volunteer to participate

Exclusion Criteria:

• Malignity history

• Head/Face surgery history

Related Conditions & MeSH terms

• COVID-19

Intervention

Other:
• mask use
long term mask use

Locations

Country	Name	City	State
Turkey	Ankara Yildirim Beyazit University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Yildirim Beyazit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Temporomandibular Dysfunction	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	Mask Use Symptoms	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
Secondary	Perceptions of Mask Use	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
Secondary	Fatigue	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
Secondary	Type of Headache	Individuals were asked to show the localization of the headache they experienced through the presented figures.	Baseline
Secondary	Trigger point of temporomandibular joint	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