Covid19OBNCT04681261
Occupational Balance, Fear and Agoraphobia
An observational study of Covid19, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to investigate occupational balance, fear of Covid-19 and agoraphobia in adults during the Covid-19 pandemic. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Covid19
- What is being tested?
- this study is not an intervention study
- How many people
- 699 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 May 2020to 4 Jun 2020
- 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 19 to 65 years
- All sexes
- Adult, Older adult
Study population: adult individuals
Who may be able to join
- between 19-65 years of age
Who cannot join
- <19 years and >65 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Occupational Balance, Fear and Agoraphobia in Adults
This study was planned to investigate occupational balance, fear of Covid-19 and agoraphobia in adults during the Covid-19 pandemic.
Read the detailed description
During the Covid-19 pandemic, the occupational balance of individuals change and the sedentary activities preferences, that pose a risk for health, increase.The outbreak also produced effects such as fear of sickness and death in addition to changing daily life and work routines, occupational balance and social participation. This study was planned to investigate occupational balance, fear of Covid-19 and agoraphobia in adults during the Covid-19 pandemic.
- Conditions
- Covid19
- Being tested
- this study is not an intervention study
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
this study is not an intervention studyOther
this study is not an intervention study
What is being measured
The primary outcome is the main question the study is designed to answer.
Occupational Balance Questionnaire
The Occupational Balance Questionnaire (OBQ) is a scale that measures self-rated OB in different dimensions. 11 item in the scale is scored on a 4-point scale from 'strongly disagree' to 'strongly agree'. The total score is obtained by summing the individual items and ranges from 0 to 33, with higher scores indicating higher OB.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start4 May 2020
- Primary completion4 Jun 2020
- Study completion4 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Hacettepe 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
- 699 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özgü İnal, Hacettepe University
- Investigators
- Özgü İnal, Principal investigator, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04681261
- Sponsor's protocol ID
- 2020/185
- Acronym
- OB
- Status last verified
- May 2020
- First submitted
- 18 Dec 2020
- Last updated
- 23 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Occupational Balance, Fear and Agoraphobia in Adults
- ClinicalTrials.gov ID
- NCT04681261
- Acronym / sponsor ID
- OB / 2020/185
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 699 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 4 May 2020 (actual)
- Primary completion
- 4 Jun 2020 (actual)
- Study completion
- 4 Jun 2020 (actual)
- First posted
- 23 Dec 2020 (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.
This study was planned to investigate occupational balance, fear of Covid-19 and agoraphobia in adults during the Covid-19 pandemic.
Detailed description
During the Covid-19 pandemic, the occupational balance of individuals change and the sedentary activities preferences, that pose a risk for health, increase.The outbreak also produced effects such as fear of sickness and death in addition to changing daily life and work routines, occupational balance and social participation. This study was planned to investigate occupational balance, fear of Covid-19 and agoraphobia in adults during the Covid-19 pandemic.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- adult individuals
Key inclusion criteria (1 listed)
- between 19-65 years of age
Key exclusion criteria (1 listed)
- <19 years and >65 years old
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 |
|---|---|---|
| this study is not an intervention studythis study is not an intervention study | Other | – |
Primary outcome
Occupational Balance Questionnaire
Time frame: 3 months
The Occupational Balance Questionnaire (OBQ) is a scale that measures self-rated OB in different dimensions. 11 item in the scale is scored on a 4-point scale from 'strongly disagree' to 'strongly agree'. The total score is obtained by summing the individual items and ranges from 0 to 33, with higher scores indicating higher OB.
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 23 Dec 2020.
- Individual participant dataSharing planned: No
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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.
Özgü İnal principal investigator
Trakya University
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 Covid19, run by Hacettepe 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 1 inclusion and 1 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 23 Dec 2020. 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?
Occupational Balance Questionnaire (time frame: 3 months). 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 23 Dec 2020.