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Olfactory and Gustatory dysfunction, Evaluation and the impact on Quality of Life among COVID-19 patients: A multicenter cross section study
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注册号：

Registration number：

 ChiCTR2300073999 

最近更新日期：

Date of Last Refreshed on：

 2023-07-27 09:18:17 

注册时间：

Date of Registration：

 2023-07-27 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Olfactory and Gustatory dysfunction, Evaluation and the impact on Quality of Life among COVID-19 patients: A multicenter cross section study

Public title：

Olfactory and Gustatory dysfunction, Evaluation and the impact on Quality of Life among COVID-19 patients: A multicenter cross section study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Olfactory and Gustatory dysfunction, Evaluation and the impact on Quality of Life among COVID-19 patients: A multicenter cross section study

Scientific title：

Olfactory and Gustatory dysfunction, Evaluation and the impact on Quality of Life among COVID-19 patients: A multicenter cross section study

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

maha alharbi 

研究负责人：

Laila Telmesani 

Applicant：

maha alharbi 

Study leader：

Laila Telmesani 

申请注册联系人电话：

Applicant telephone：

 +966 53 651 3396

研究负责人电话：

Study leader's
telephone：

+966 13 896 6666

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 mahasayyah@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 itelmesani@iau.edu.sa

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

Imam Abdulrahman Bin Faisal University

研究负责人通讯地址：

Imam Abdulrahman Bin Faisal University

Applicant address：

Imam Abdulrahman Bin Faisal University

Study leader's address：

Imam Abdulrahman Bin Faisal University

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

Imam Abdulrahman Bin Faisal University

Applicant's institution：

Imam Abdulrahman Bin Faisal University

研究负责人所在单位：

Imam Abdulrahman Bin Faisal University

Affiliation of the Leader：

Imam Abdulrahman Bin Faisal University

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2020-01-181

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

Institutional Review Board of Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia

Name of the ethic committee：

Institutional Review Board of Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia

伦理委员会批准日期：

Date of approved by ethic committee：

 2020-06-18 00:00:00

伦理委员会联系人：

Professor Badr Abdulrahman Aljandan

Contact Name of the ethic committee：

Professor Badr Abdulrahman Aljandan

伦理委员会联系地址：

Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabi

Contact Address of the ethic committee：

Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabi

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +966 13 333 0190

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

Imam Abdulrahman Bin Faisal University

Primary sponsor：

Imam Abdulrahman Bin Faisal University

研究实施负责（组长）单位地址：

Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabi

Primary sponsor's address：

Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabi

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

SAUDI ARABIA

省(直辖市)：

Dammam

市(区县)：

Country：

SAUDI ARABIA

Province：

Dammam

City：

单位(医院)：

King Fahd Hospital of the University

具体地址：

Bashar Bin Bard St Khobar 34445

Institution
hospital：

King Fahd Hospital of the University

Address：

Bashar Bin Bard St Khobar 34445

经费或物资来源：

No

Source(s) of funding：

No

研究疾病：

Olfactory and Gustatory dysfunction in COVID-19  

Target disease：

Olfactory and Gustatory dysfunction in COVID-19

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

横断面 

Study design：

Cross-sectional 

研究目的：

1. Characterize the occurrence of olfactory and gustatory dysfunctions among COVID-19 confirmed cases in Saudi Arabia and the effect of these chemosensory changes in the quality of life. 2. To investigate the occurrence of olfactory and gustatory dysfunctions in patients with laboratory-confirmed COVID-19 infection. 3. To investigate If infected patients just present with olfactory and gustatory dysfunctions without other significant complaints. And to address sudden anosmia or ageusia as important symptoms of the COVID-19 infection. 4. Address the change in the taste and smell among study participants and the effect of these chemosensory changes on their quality of life 5. Analyze the effect of Quality of life based on QOL survey pattern 6. Analyze the effect of older age, gender, comorbidity ,Late presentation , History of ICU admition and nationality as risk factors related to spreaders  

Objectives of Study：

1. Characterize the occurrence of olfactory and gustatory dysfunctions among COVID-19 confirmed cases in Saudi Arabia and the effect of these chemosensory changes in the quality of life. 2. To investigate the occurrence of olfactory and gustatory dysfunctions in patients with laboratory-confirmed COVID-19 infection. 3. To investigate If infected patients just present with olfactory and gustatory dysfunctions without other significant complaints. And to address sudden anosmia or ageusia as important symptoms of the COVID-19 infection. 4. Address the change in the taste and smell among study participants and the effect of these chemosensory changes on their quality of life 5. Analyze the effect of Quality of life based on QOL survey pattern 6. Analyze the effect of older age, gender, comorbidity ,Late presentation , History of ICU admition and nationality as risk factors related to spreaders

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

• patients with olfactory or gustatory dysfunctions before the pandemic. • patient known sinonasal disease with persistence symptoms before the pandemic. • patients without a laboratory-confirmed COVID-19 infection diagnosis. • sever COVID-19 cases and critically ill at time of study (unable to fulfill the questionnaire

Exclusion criteria：

• patients with olfactory or gustatory dysfunctions before the pandemic. • patient known sinonasal disease with persistence symptoms before the pandemic. • patients without a laboratory-confirmed COVID-19 infection diagnosis. • sever COVID-19 cases and critically ill at time of study (unable to fulfill the questionnaire

研究实施时间：

Study execute time：

从 From 2020-10-01 00:00:00至 To 2020-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2020-10-01 00:00:00 至 To 2020-12-31 00:00:00

干预措施：

Interventions：

组别：

COVID-19 patients

样本量：

 1734

Group：

COVID-19 patients

Sample size：

干预措施：

None

干预措施代码：

Intervention：

None

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 SAUDI ARABIA

省(直辖市)：

 Dammam 

市(区县)：

  

Country：

SAUDI ARABIA

Province：

Dammam

City：

单位(医院)：

 King Fahd Hospital of the University 

单位级别：

  

Institution
hospital：

King Fahd Hospital of the University

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

prevalence of chemosensory dysfunction

指标类型：

主要指标

Outcome：

prevalence of chemosensory dysfunction

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

None

组织：

Sample Name：

None

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 100 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

None

Randomization Procedure (please state who generates the random number sequence and by what method)：

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Blinding：

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

是Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

using hospital data , no data based system

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

using hospital data , no data based system

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

survey based data collection ( patients were recruited from hospital ), SPSS data analysis toll was used

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

survey based data collection ( patients were recruited from hospital ), SPSS data analysis toll was used

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2023-07-27 09:18:12
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