SARS-CoV-2NCT04631172
Covid-19 Anxiety and Phobia Levels of the Parents
An observational study of SARS-CoV-2 and Anxiety and Fear, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2, Anxiety and Fear, Parents
- What is being tested?
- Coronavirus Anxiety Scale , COVID-19 Phobia Scale
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2020to 15 Oct 2020
- How long will I take part?
- 5 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The parents of pediatric patients who were scheduled to undergo surgery under general anesthesia in Turkey
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Selcuk University, School of Medicine
Konya, 42250
About this study
Official title: 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.
Read the 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).
- Conditions
- SARS-CoV-2, Anxiety and Fear, Parents
- Being tested
- Coronavirus Anxiety Scale , COVID-19 Phobia Scale
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronavirus Anxiety Scale , COVID-19 Phobia ScaleOther
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronavirus Anxiety Scale (CAS)
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.
Measured: 5 months
COVID 19 phobia scale (C19P-S)
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.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start1 May 2020
- Primary completion30 Sep 2020
- Study completion15 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
- Target duration
- 5 Months
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faruk Cicekci, Selcuk University
- Investigators
- Faruk Cicekci, Principal investigator, Selcuk University, School of Medicine, Department of Anesthesiology and Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04631172
- Sponsor's protocol ID
- farukcicekci
- Status last verified
- Nov 2020
- First submitted
- 14 Nov 2020
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Covid-19 Anxiety and Phobia Levels of the Parents of Pediatric Patients
- ClinicalTrials.gov ID
- NCT04631172
- Acronym / sponsor ID
- farukcicekci
- Conditions
- SARS-CoV-2, Anxiety and Fear, Parents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 17 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The parents of pediatric patients who were scheduled to undergo surgery under general anesthesia in Turkey
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronavirus Anxiety Scale , COVID-19 Phobia ScaleUsing two questionnaire completed in face-to-face interviews Participants were asked the Coronavirus Anxiety Scale (CAS), and the COVID-19 Phobia Scale (C19P-S). | Other | – |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faruk Cicekci principal investigator
Selcuk University, School of Medicine, Department of Anesthesiology and Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2 and Anxiety and Fear, run by Selcuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronavirus Anxiety Scale (CAS) (time frame: 5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2020.