Covid-19 Anxiety and Phobia Levels of the Parents

• ClinicalTrials.gov Identifier: NCT04631172
• Recruitment Status: Completed
• First Posted: November 17, 2020
• Last Update Posted: November 18, 2020
• Sponsor: Selcuk University
• Information provided by (Responsible Party): Faruk Cicekci, Selcuk University

Study Description

Brief Summary:

A pandemic that originated in the Wuhan region of China in December 2019 was detected as a new type of coronavirus disease called coronavirus 2019 (COVID-19). In the first phase of the outbreak, specialists explained ways to maintain physical health . However, pediatric surgical procedures and anesthesia applications continued during this period. Surgery in pediatric patients is an unpleasant and potentially 'threatening' experience, often followed by preoperative anxiety due to the child's illness, hospitalization, fear of anesthesia - especially the time of anesthesia induction - and the surgery itself . Anesthesia is a stressful procedure for the child and the entire family. Both the COVID-19 pandemic and the surgical procedure are reflected in the symptoms of anxiety, fear or acute stress disorder for children and their families. As the disease spread, investigators started to emphasize the importance of protecting mental health. Identifying factors that contribute to significant preoperative anxiety levels in pediatric patients and their parents can help healthcare professionals choose the most appropriate from a variety of alternative strategies for anxiety control. This study was planned to evaluate the COVID-19 anxiety and phobia levels of the parents of pediatric patients are scheduled to undergo surgery under general anesthesia in Turkey.

Condition or disease	Intervention/treatment
SARS-CoV-2; Anxiety and Fear; Parents	Other: Coronavirus Anxiety Scale , COVID-19 Phobia Scale

Detailed Description:

The population of the study was created from the parents of pediatric patients who were scheduled for surgery under general anesthesia between May 2020 and September 2020 at Selcuk University Department of Anesthesiology and Reanimation. The data were obtained through face-to-face interviews before the child was taken to surgery after the necessary explanations were made to the parents of the children by the researchers. To enable the parents to answer the questions easily, a separate room in the relevant clinic was used for the interviews. The characteristics of the children and parents, supplementary data of the parents regarding the child's illness, and contact information were obtained. Participants were asked to complete a sociodemographic data form, the Coronavirus Anxiety Scale (CAS), and the COVID-19 Phobia Scale (C19P-S).

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 150 participants
• Observational Model: Other
• Time Perspective: Cross-Sectional
• Target Follow-Up Duration: 5 Months
• Official Title: Evaluation of Covid-19 Anxiety and Phobia Levels of the Parents of Pediatric Patients
• Actual Study Start Date: May 1, 2020
• Actual Primary Completion Date: September 30, 2020
• Actual Study Completion Date: October 15, 2020

Groups and Cohorts

Intervention Details:

• Other: Coronavirus Anxiety Scale , COVID-19 Phobia Scale
  Using two questionnaire completed in face-to-face interviews Participants were asked the Coronavirus Anxiety Scale (CAS), and the COVID-19 Phobia Scale (C19P-S).

Outcome Measures

Primary Outcome Measures :

1. Coronavirus Anxiety Scale (CAS) [ Time Frame: 5 months ]
   The Coronavirus Anxiety Scale (CAS), which was developed by Lee and validated in Turkish by Evren et al., was used to evaluate the COVID-19 anxiety level. In the validation study, the Cronbach's alpha of the Turkish version of CAS was 0.87. This results of the study showed that the CAS was highly reliable. CAS is a 5-point Likert-type scale. The scale consists of five questions and one dimension. Scoring of the scale is evaluated as 0 = never, 1 = rare, less than a day or two, 2 = a few days, 3 = more than a week, and 4 = almost every day in the last two weeks. The total score ranges from 0 to 20. Lee determined the CAS cut-off score of 9 to distinguish those with dysfunctional anxiety from those without anxiety.
2. COVID 19 phobia scale (C19P-S) [ Time Frame: 5 months ]
   COVID 19 phobia scale (C19P-S) is a 20-item, 4-subdimension (psychological, somatic, social and economic) scale in which items are answered in a 5-point response format developed by Arpacı et al. 7 to measure the phobia that may develop against COVID-19. In the validation study, the Cronbach's alpha of the Turkish version of C19P-S was 0.92. In the present study, Cronbach's alpha was 0.94. The results of the study demonstrated that the C19P-S was exceptionally reliable. The scale items are rated between 1 "strongly disagree" and 5, "strongly agree. Sub-dimension scores are obtained by the sum of the points of the answers given to the items belonging to that sub-dimension, while the total C19P-S score is obtained by the total of the subdimension scores, ranging between 20 and 100 points.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

The parents of pediatric patients who were scheduled to undergo surgery under general anesthesia in Turkey

Criteria

Inclusion Criteria:

• Parents of pediatric patients with American Society of Anesthesiologists classification (ASA) I-II, aged 1-12 years who were administered anesthesia to undergo surgery were included in the study.

Exclusion Criteria:

• Parents of children with ASA III or higher risk, expected to have difficult intubation, serious complications related to intraoperative surgery or anesthesia (e.g. respiratory depression, myocardial depression, cardiac arrhythmia, bronchospasm, laryngospasm, anaphylactic reaction, hypotension, bleeding), and could not communicate were excluded from the study.

Contacts and Locations

Locations

Turkey

Selcuk University, School of Medicine

Konya, Turkey, 42250

Sponsors and Collaborators

Selcuk University

Investigators

• Principal Investigator: Faruk Cicekci; Selcuk University, School of Medicine, Department of Anesthesiology and Intensive Care

More Information

• Responsible Party: Faruk Cicekci, Principal investigator, Selcuk University
• ClinicalTrials.gov Identifier: NCT04631172
• Other Study ID Numbers: farukcicekci
• First Posted: November 17, 2020
• Last Update Posted: November 18, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Anxiety Disorders; Mental Disorders