- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04631172
Covid-19 Anxiety and Phobia Levels of the Parents
November 16, 2020 updated by: Faruk Cicekci, Selcuk University
Evaluation of Covid-19 Anxiety and Phobia Levels of the Parents of Pediatric Patients
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Konya, Turkey, 42250
- Selcuk University, School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The parents of pediatric patients who were scheduled to undergo surgery under general anesthesia in Turkey
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Coronavirus Anxiety Scale (CAS)
Time Frame: 5 months
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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.
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5 months
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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.
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5 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Faruk Cicekci, Selcuk University, School of Medicine, Department of Anesthesiology and Intensive Care
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2020
Primary Completion (Actual)
September 30, 2020
Study Completion (Actual)
October 15, 2020
Study Registration Dates
First Submitted
November 14, 2020
First Submitted That Met QC Criteria
November 14, 2020
First Posted (Actual)
November 17, 2020
Study Record Updates
Last Update Posted (Actual)
November 18, 2020
Last Update Submitted That Met QC Criteria
November 16, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- farukcicekci
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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