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COVID-19 Pandemic and Parents of Disabled Children

Primary Purpose

COVID-19, Disabilities Multiple, Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Difficulties lived by disabled children's parents in the period of COVID-19 pandemic
Sponsored by
Gaziosmanpasa Research and Education Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for COVID-19 focused on measuring cerebral palsy, COVID-19, pandemic, disability

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Health Science University Gaziosmanpasa Training and Research Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Parents who have a disabled child or children

Arm Description

Parents having disabled child or children will be included in the research and it will be wanted to complete the survey questionary

Outcomes

Primary Outcome Measures

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
Difficulties related to rehabilitation facilities, other medical conditions or ortosis could increase because of Covid 19 pandemic unique conditions

Secondary Outcome Measures

The Fear of COVID-19 Scale
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.

Full Information

First Posted
June 28, 2020
Last Updated
October 31, 2020
Sponsor
Gaziosmanpasa Research and Education Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04525742
Brief Title
COVID-19 Pandemic and Parents of Disabled Children
Official Title
COVID-19 Pandemic From the Perspective of Parents of Disabled Children
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
July 5, 2020 (Actual)
Primary Completion Date
August 30, 2020 (Actual)
Study Completion Date
September 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gaziosmanpasa Research and Education Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Disabilities Multiple, Cerebral Palsy, Muscular Dystrophies
Keywords
cerebral palsy, COVID-19, pandemic, disability

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
One study group will be researched- only disabled children's parents, in one arm -way
Masking
None (Open Label)
Masking Description
No masking will be done
Allocation
N/A
Enrollment
309 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parents who have a disabled child or children
Arm Type
Other
Arm Description
Parents having disabled child or children will be included in the research and it will be wanted to complete the survey questionary
Intervention Type
Other
Intervention Name(s)
Difficulties lived by disabled children's parents in the period of COVID-19 pandemic
Intervention Description
It will be a cross sectional study to obtain the information on difficulties lived by disabled children's parents during recent pandemic period
Primary Outcome Measure Information:
Title
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
Description
Difficulties related to rehabilitation facilities, other medical conditions or ortosis could increase because of Covid 19 pandemic unique conditions
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
The Fear of COVID-19 Scale
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Resa Aydin, Professor
Organizational Affiliation
İstanbul University İstanbul Faculty of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Evrim Karadağ Saygı, Professor
Organizational Affiliation
Marmara University Faculty of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Özden Özyemisçi Taşkıran, Professor
Organizational Affiliation
Koc University Faculty of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nalan Çapan, Professor
Organizational Affiliation
İstanbul University İstanbul Faculty of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ebru Yilmaz Yalçınkaya, Professor
Organizational Affiliation
Health Science University
Official's Role
Study Director
Facility Information:
Facility Name
Health Science University Gaziosmanpasa Training and Research Hospital
City
İstanbul
State/Province
Gaziosmanpasa
ZIP/Postal Code
34255
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
32226353
Citation
Ahorsu DK, Lin CY, Imani V, Saffari M, Griffiths MD, Pakpour AH. The Fear of COVID-19 Scale: Development and Initial Validation. Int J Ment Health Addict. 2022;20(3):1537-1545. doi: 10.1007/s11469-020-00270-8. Epub 2020 Mar 27.
Results Reference
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COVID-19 Pandemic and Parents of Disabled Children

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