Psychosocial Factors and Quality of Life in the Effect of Fear of COVID-19 With Cystic Fibrosis

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.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Behavioral: Survey Form, The Hospital Anxiety and Depression Scale, The Fear of COVID-19 Scale,World Health Organization Quality of Life Scale- Bref Form

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 Type: Observational
• Enrollment (Actual): 128

Contacts and Locations

Study Locations

• Turkey
  • İ̇stanbul
    • Istanbul, İ̇stanbul, Turkey, 34734
      • Elif Kabasakal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Online questionnaires were administered to individuals.
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; Online questionnaires were administered to individuals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	November-December/2021November-December/2021

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
quality of life assessment	It is an internationally comparable assessment tool developed by the World Health Organization. The scale evaluates the level of quality of life. The scale consists of 26 items. The Turkish version of WHOQOL-Bref consists of 27 items. Question 27 has been added to the Turkish version of the scale as a national environmental field and is used only in national studies. The scale includes the areas of physical health, psychological health, social relations, environment and national environment. It has a 5-point likert-type rating system. The score of each area is important on its own. Higher scores in each area indicate better quality of life. The first two questions of the quality of life scale are not included in the scoring and are evaluated separately. The number of questions, which was 26 in the original of the scale, is used as 27 in the Turkish version.	November-December/2021November-December/2021

Collaborators and Investigators

• Sponsor: Elif Kabasakal

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2021
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): December 25, 2021

Study Registration Dates

• First Submitted: January 13, 2022
• First Submitted That Met QC Criteria: January 13, 2022
• First Posted (Actual): January 18, 2022

Study Record Updates

• Last Update Posted (Actual): January 18, 2022
• Last Update Submitted That Met QC Criteria: January 13, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: MedipolU-KABASAKAL-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No