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Use of the Mask and Current Pandemic (Mask)

2022年8月19日更新者：GEMMA V ESPÍ LÓPEZ, PhD、University of Valencia

Population Impact on the Continued Use of the Mask Due to the Avoidance of COVID-19

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.

研究概览

地位

完全的

条件

面膜挤压

详细说明

Introduction

Material and methods

Diseny. 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.

Participants. 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. The study will be carried out at the Faculty of Physiotherapy of the University of Valencia. The participants will sign an informed consent guaranteeing the confidentiality of the data. The study is approved by the ethics committee of our institution.

Outcomes. The sociodemographic characteristics and the use of the mask will be collected. Subsequently, the evaluation instruments without the use of a mask and with the use of the same in: Headache and the impact on headaches, pain related to temporomandibular joint and quality of life.

All data will be coded in a database and analyzed later.

研究类型

观察性的

注册 (实际的)

542

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

西班牙
- - Valencia、西班牙、46010
    - Gemma Victoria Espí-López

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

概率样本

研究人群

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.

描述

Inclusion Criteria:

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.

Exclusion Criteria:

I do not use the mask
institutionalized subjects

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Headache 大体时间：1 day	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 大体时间：1 day	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

次要结果测量

结果测量	措施说明	大体时间
Headache Impact 大体时间：1 day	Headache Impact Test-6 (HIT-6).To measure the impact of headache. The score is calculated as follows: never (6 points), few times (8 points), sometimes (10 points), very often (11 points) and always (13 points). With a total of 49 or less points is considered "little or no impact", between 50-55 "some impact", between 56-59 "significant impact" and 60 or more "very severe impact".	1 day
Influence on quality of life 大体时间：1 day	Will be measured by Cantril Ladder of Life Scale (LADER). The Cantril Staircase (Cantril 1965), measures satisfaction with life. The subject is asked to imagine his life in the best possible way and to describe his hopes and wishes. You are then asked to imagine your future in the worst possible light, your fears and concerns associated with this outcome. Subsequently, the respondent is presented with an image consisting of a ladder numbered from zero to ten, where the top of the ladder represents the best possible life for the subject = 10 and the bottom of the ladder represents the worst possible life = 0.	1 day

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Valencia

调查人员

首席研究员：Gemma V Espí-López、fisiotherapy

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年2月4日

初级完成 (实际的)

2021年3月1日

研究完成 (实际的)

2021年3月30日

研究注册日期

首次提交

2021年1月22日

首先提交符合 QC 标准的

2021年1月22日

首次发布 (实际的)

2021年1月27日

研究记录更新

最后更新发布 (实际的)

2022年8月24日

上次提交的符合 QC 标准的更新

2022年8月19日

最后验证

2022年8月1日