Cystic FibrosisNCT05195216
Psychosocial Factors and Quality of Life in the Effect of Fear of COVID-19 With Cystic Fibrosis
An observational study of Cystic Fibrosis, run by Elif Kabasakal at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study; The COVID-19 pandemic is to investigate the effects of COVID-19 fear levels of patients with cystic fibrosis on the psychosocial and quality of life levels of individuals. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Survey Form, The Hospital Anxiety and Depression Scale, The Fear of COVID-19 Scale,World Health Organization Quality of Life Scale- Bref Form
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2021to 25 Dec 2021
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 64 individuals with cystic fibrosis and 70 healthy individuals participated in the study.
Who may be able to join
- be 16 years of age or older
- Having been diagnosed with Cystic Fibrosis
- Volunteering to participate in the research
Who cannot join
- Being mentally incapable of successfully applying the scales to be applied for evaluation purposes
- Being treated with sedative and antiepileptic drugs
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study; The COVID-19 pandemic is to investigate the effects of COVID-19 fear levels of patients with cystic fibrosis on the psychosocial and quality of life levels of individuals.
Read the detailed description
After individuals were informed about the study, it was administered to individuals who gave written informed consent.This study was carried out on individuals with cystic fibrosis and healthy individuals who meet the eligibility requirements, through online forms.
- Conditions
- Cystic Fibrosis
- Being tested
- Survey Form, The Hospital Anxiety and Depression Scale, The Fear of COVID-19 Scale,World Health Organization Quality of Life Scale- Bref Form
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey Form, The Hospital Anxiety and Depression Scale, The Fear of COVID-19 Scale,World Health Organization Quality of Life Scale- Bref FormBehavioural
Online questionnaires were administered to individuals.
| Study group | Role | What they receive |
|---|---|---|
| individuals with cystic fibrosis | Not described Receives: Behavioral: Survey Form, The Hospital Anxiety and Depression Scale, The Fear of COVID-19 Scale,World Health Organization Quality of Life Scale- Bref Form | |
| healthy individuals | Not described Receives: Behavioral: Survey Form, The Hospital Anxiety and Depression Scale, The Fear of COVID-19 Scale,World Health Organization Quality of Life Scale- Bref Form |
What is being measured
The primary outcome is the main question the study is designed to answer.
fear of covid-19
COVID-19 Fear Scale: This scale is a one-dimensional instrument consisting of seven items with robust psychometric properties that measure fear of COVID-19. It has a 5-point Likert-type rating system (1: Strongly disagree, 5: Strongly agree). It is reliable and valid in assessing fear of COVID-19 among the general population. Turkish validity and reliability of the scale were ensured.
Measured: November- December/2021
Secondary outcomes (1)
psychosocial factors
Hospital Anxiety and Depression Scale (HADS): The scale consists of 14 items. 7 of these items measure anxiety and 7 of them measure depression symptoms. The items in the scale are evaluated with a 4-point Likert scale and are based on a scoring system between 0-3.
Measured: November-December/2021November-December/2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start20 Nov 2021
- Primary completion30 Nov 2021
- Study completion25 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elif Kabasakal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elif Kabasakal, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05195216
- Sponsor's protocol ID
- MedipolU-KABASAKAL-001
- Status last verified
- Jan 2022
- First submitted
- 13 Jan 2022
- Last updated
- 18 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Factors and Quality of Life in the Effect of Fear of COVID-19 With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT05195216
- Acronym / sponsor ID
- MedipolU-KABASAKAL-001
- Conditions
- Cystic Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Elif KabasakalUniversity, hospital or other
- Study start
- 20 Nov 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 25 Dec 2021 (actual)
- First posted
- 18 Jan 2022 (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.
The purpose of this study; The COVID-19 pandemic is to investigate the effects of COVID-19 fear levels of patients with cystic fibrosis on the psychosocial and quality of life levels of individuals.
Detailed description
After individuals were informed about the study, it was administered to individuals who gave written informed consent.This study was carried out on individuals with cystic fibrosis and healthy individuals who meet the eligibility requirements, through online forms.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| individuals with cystic fibrosis | – | Behavioral: Survey Form, The Hospital Anxiety and Depression Scale, The Fear of COVID-19 Scale,World Health Organization Quality of Life Scale- Bref Form |
| healthy individuals | – | Behavioral: Survey Form, The Hospital Anxiety and Depression Scale, The Fear of COVID-19 Scale,World Health Organization Quality of Life Scale- Bref Form |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 64 individuals with cystic fibrosis and 70 healthy individuals participated in the study.
Key inclusion criteria (3 listed)
- be 16 years of age or older
- Having been diagnosed with Cystic Fibrosis
- Volunteering to participate in the research
Key exclusion criteria (3 listed)
- Being mentally incapable of successfully applying the scales to be applied for evaluation purposes
- Being treated with sedative and antiepileptic drugs
- Pregnancy
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 |
|---|---|---|
| Survey Form, The Hospital Anxiety and Depression Scale, The Fear of COVID-19 Scale,World Health Organization Quality of Life Scale- Bref FormOnline questionnaires were administered to individuals. | Behavioural | healthy individuals, individuals with cystic fibrosis |
Primary outcome
fear of covid-19
Time frame: November- December/2021
COVID-19 Fear Scale: This scale is a one-dimensional instrument consisting of seven items with robust psychometric properties that measure fear of COVID-19. It has a 5-point Likert-type rating system (1: Strongly disagree, 5: Strongly agree). It is reliable and valid in assessing fear of COVID-19 among the general population. Turkish validity and reliability of the scale were ensured.
1 secondary outcome
psychosocial factors
Time frame: November-December/2021November-December/2021
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 18 Jan 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cystic Fibrosis, run by Elif Kabasakal 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 3 inclusion and 3 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 18 Jan 2022. 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?
fear of covid-19 (time frame: November- December/2021). 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 18 Jan 2022.