- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04525742
COVID-19 Pandemic and Parents of Disabled Children
October 31, 2020 updated by: Berrin Hüner, Gaziosmanpasa Research and Education Hospital
COVID-19 Pandemic From the Perspective of Parents of Disabled Children
Pandemic period could affect the disabled children's rehabilitation and follow-up negatively because of preventive measures and this could create adverse results on their parents.
In this research, it is aimed to determine the positive and negative effects of pandemic on parents and disabled children and to provide an insight for future solutions.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
To determine the effect of COVID-19 pandemic and the possible difficulties experienced by the parents of disabled children, a questionnaire was prepared.
It takes approximately 10-15 minutes to complete the survey.
Questionnaire is loaded to qualtrics program and sent to the families by e-mail or social media accounts.
Study Type
Interventional
Enrollment (Actual)
309
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gaziosmanpasa
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İstanbul, Gaziosmanpasa, Turkey, 34255
- Health Science University Gaziosmanpasa Training and Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Having disabled child/children
- Having ability and facility to use internet
- Having ability to read and write
- Having enough cognitive capacity to answer the questionnaire
- To accept to participate the research
Exclusion Criteria:
- Not having disabled child/children
- Not having ability and facility to use internet
- Not having ability to read and write
- Not having enough cognitive capacity to answer the questionnaire
- Not to accept to participate the research
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Parents who have a disabled child or children
Parents having disabled child or children will be included in the research and it will be wanted to complete the survey questionary
|
It will be a cross sectional study to obtain the information on difficulties lived by disabled children's parents during recent pandemic period
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
A questionnaire that we created will be used to determine the difficulties experienced by disabled children's parents during Covid 19 pandemic related to their medical follow-up
Time Frame: 4 weeks
|
Difficulties related to rehabilitation facilities, other medical conditions or ortosis could increase because of Covid 19 pandemic unique conditions
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Fear of COVID-19 Scale
Time Frame: 4 weeks
|
The Fear of COVID-19 Scale, a seven-item scale, has robust psychometric properties.
It is reliable and valid in assessing fear of COVID-19 among the general population and will also be useful in allaying COVID-19 fears among individuals.
Score is minimum 7 pointts and maximum 35 points.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Resa Aydin, Professor, Istanbul University Istanbul Faculty of Medicine
- Principal Investigator: Evrim Karadağ Saygı, Professor, Marmara University Faculty of Medicine
- Principal Investigator: Özden Özyemisçi Taşkıran, Professor, Koc University Faculty of Medicine
- Principal Investigator: Nalan Çapan, Professor, Istanbul University Istanbul Faculty of Medicine
- Study Director: Ebru Yilmaz Yalçınkaya, Professor, Health Science University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 5, 2020
Primary Completion (Actual)
August 30, 2020
Study Completion (Actual)
September 15, 2020
Study Registration Dates
First Submitted
June 28, 2020
First Submitted That Met QC Criteria
August 23, 2020
First Posted (Actual)
August 25, 2020
Study Record Updates
Last Update Posted (Actual)
November 3, 2020
Last Update Submitted That Met QC Criteria
October 31, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Brain Damage, Chronic
- Genetic Diseases, Inborn
- Musculoskeletal Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Muscular Disorders, Atrophic
- COVID-19
- Cerebral Palsy
- Muscular Dystrophies
Other Study ID Numbers
- 105
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Study protocol was established by Berrin Huner and Ebru Yilmaz Yalcınkaya Statistical analysis (Power analysis) was established by Ozden Ozyemisci Taskiran Informed consent was written by Berrin Huner
IPD Sharing Time Frame
Research is planned to bu conducted between June 15 th and July 15 th 2020.
After 15 th of July in 1 week coming statistical analysis will be finished and than in 3 weeks article will be written
IPD Sharing Access Criteria
In necessary cases colleced data from the research will be shared with the local ethical committe
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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