NCT05195216

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2021

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2021

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 18, 2022

Completed
Last Updated

January 18, 2022

Status Verified

January 1, 2022

Enrollment Period

10 days

First QC Date

January 13, 2022

Last Update Submit

January 13, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    November- December/2021

Secondary Outcomes (1)

  • psychosocial factors

    November-December/2021November-December/2021

Other Outcomes (1)

  • quality of life assessment

    November-December/2021November-December/2021

Study Arms (2)

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

Interventions

Online questionnaires were administered to individuals.

healthy individualsindividuals with cystic fibrosis

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

64 individuals with cystic fibrosis and 70 healthy individuals participated in the study.

You may qualify if:

  • be 16 years of age or older
  • Having been diagnosed with Cystic Fibrosis
  • Volunteering to participate in the research

You may not qualify if:

  • Being mentally incapable of successfully applying the scales to be applied for evaluation purposes
  • Being treated with sedative and antiepileptic drugs
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elif Kabasakal

Istanbul, İ̇stanbul, 34734, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
ekabasakal

Study Record Dates

First Submitted

January 13, 2022

First Posted

January 18, 2022

Study Start

November 20, 2021

Primary Completion

November 30, 2021

Study Completion

December 25, 2021

Last Updated

January 18, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations