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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05195216
• Other study ID #: MedipolU-KABASAKAL-001
• Status: Completed
• Start date: November 20, 2021
• Est. completion date: December 25, 2021

Study information

• Verified date: January 2022
• Source: Medipol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: December 25, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

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.

Locations

Country	Name	City	State
Turkey	Elif Kabasakal	Istanbul	I?stanbul

Sponsors (1)

Lead Sponsor	Collaborator
Elif Kabasakal

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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