COVID-19NCT05358665
The Effects of Long-Term Mask Use in the Pandemic Period
An observational study of COVID-19, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- mask use
- How many people
- 909 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2021to 15 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People using masks
Who may be able to join
- Over 18 years
- Able to read and understand
- Volunteer to participate
Who cannot join
- Malignity history
- Head/Face surgery history
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- COVID-19
- Being tested
- mask use
- Keywords
- mask, temporomandibular joint disorders, headache, fatigue
- Medical subject headings
- COVID-19, Temporomandibular Joint Disorders, Headache, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mask useOther
long term mask use
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | There are individuals who use masks for less than 4 hours daily. Receives: Other: mask use | |
| Group 2 | There are individuals who use masks for 4-8 hours daily. Receives: Other: mask use | |
| Group 3 | There are individuals who use masks for more than 8 hours daily. Receives: Other: mask use |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (5)
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
Type of Headache
Individuals were asked to show the localization of the headache they experienced through the presented figures.
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start1 May 2021
- Primary completion31 Aug 2021
- Study completion15 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 909 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05358665
- Sponsor's protocol ID
- 2021-586/58
- Status last verified
- Apr 2022
- First submitted
- 28 Apr 2022
- Last updated
- 3 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of Temporomandibular Pain, Headache, and Fatigue in Relation With Long-Term Mask Use During the Pandemics
- ClinicalTrials.gov ID
- NCT05358665
- Acronym / sponsor ID
- 2021-586/58
- Conditions
- COVID-19
- Keywords
- mask, temporomandibular joint disorders, headache, fatigue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 909 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 3 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: mask useThere are individuals who use masks for less than 4 hours daily. |
| Group 2 | – | Other: mask useThere are individuals who use masks for 4-8 hours daily. |
| Group 3 | – | Other: mask useThere are individuals who use masks for more than 8 hours daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People using masks
Key inclusion criteria (3 listed)
- Over 18 years
- Able to read and understand
- Volunteer to participate
Key exclusion criteria (2 listed)
- Malignity history
- Head/Face surgery history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mask uselong term mask use | Other | Group 1, Group 2, Group 3 |
Primary outcome
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.
5 secondary outcomes
Mask Use Symptoms
Time frame: Baseline
Perceptions of Mask Use
Time frame: Baseline
Fatigue
Time frame: Baseline
Type of Headache
Time frame: Baseline
Trigger point of temporomandibular joint
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temporomandibular Dysfunction (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2022.