AnxietyNCT04715477
Intensive Care Anxiety in SARS-CoV-2 Patients
An observational study of Anxiety, run by Derince Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
It should be known by the clinician that COVID-19 patients are prone to anxiety, and these disorders need to be properly diagnosed and addressed to improve prognosis, shorten hospital stay and avoid long-term mental health problems. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety
- What is being tested?
- Hospital Anxiety Depression Measure
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jan 2021to 15 Apr 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Co-operative patients over 18 years of age, with COVID PCR + admission to intensive care unit, will be included in the study.
Who may be able to join
- Above 18 years old
- COVID PCR +,
- admitted to intensive care,
- conscious, cooperative patients
Who cannot join
- Having hearing and speaking problems,
- Can't speak Turkish or English,
- who do not have the cognitive level to understand and answer the questions,
- Communication problems such as dementia and Alzheimer's,
- patients receiving sedation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
İlke Küpeli
İzmit, Kocaeli̇
İLKE KÜPELİ
About this study
Official title: Intensive Care Anxiety in SARS-CoV-2 (COVID 19) Patients
It should be known by the clinician that COVID-19 patients are prone to anxiety, and these disorders need to be properly diagnosed and addressed to improve prognosis, shorten hospital stay and avoid long-term mental health problems.
- Conditions
- Anxiety
- Being tested
- Hospital Anxiety Depression Measure
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospital Anxiety Depression MeasureBehavioural
Hospital Anxiety Depression Measure
| Study group | Role | What they receive |
|---|---|---|
| Hospital Anxiety Depression Measure | Hospital Anxiety Depression Measure Receives: Behavioral: Hospital Anxiety Depression Measure |
What is being measured
The primary outcome is the main question the study is designed to answer.
intensive care Anxiety
Hospital Anxiety Depression scale
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start17 Jan 2021 (estimated)
- Primary completion1 Apr 2021 (estimated)
- Study completion15 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Derince Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İLKE KÜPELİ, Derince Training and Research Hospital
- Investigators
- ilke kupeli, Principal investigator, Derince Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715477
- Sponsor's protocol ID
- derince TRH 2
- Status last verified
- Jan 2021
- First submitted
- 15 Jan 2021
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Deng J, Zhou F, Hou W, Silver Z, Wong CY, Chang O, Huang E, Zuo QK. The prevalence of depression, anxiety, and sleep disturbances in COVID-19 patients: a meta-analysis. Ann N Y Acad Sci. 2021 Feb;1486(1):90-111. doi: 10.1111/nyas.14506. Epub 2020 Oct 2.
PubMed 33009668Rogers JP, Chesney E, Oliver D, Pollak TA, McGuire P, Fusar-Poli P, Zandi MS, Lewis G, David AS. Psychiatric and neuropsychiatric presentations associated with severe coronavirus infections: a systematic review and meta-analysis with comparison to the COVID-19 pandemic. Lancet Psychiatry. 2020 Jul;7(7):611-627. doi: 10.1016/S2215-0366(20)30203-0. Epub 2020 May 18.
PubMed 324376793. Aydemir Ö, Güvenir T, Küey L, Kültür S. Hastane Anksiyete ve Depresyon Ölçeği Türkçe Formunun Geçerlik Güvenilirlik Çalışması. Türk Psikiyatri Dergisi 1997;8:280-287.
Kupeli I, Kara MY, Yakin I, Caglayan AC. Anxiety and depression in the first 24 h in COVID-19 patients who underwent non-invasive mechanical ventilation in the intensive care unit. Ir J Med Sci. 2022 Oct;191(5):2291-2295. doi: 10.1007/s11845-021-02808-8. Epub 2021 Oct 19.
PubMed 34664224
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Care Anxiety in SARS-CoV-2 (COVID 19) Patients
- ClinicalTrials.gov ID
- NCT04715477
- Acronym / sponsor ID
- derince TRH 2
- Conditions
- Anxiety
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Derince Training and Research HospitalUniversity, hospital or other
- Study start
- 17 Jan 2021 (estimated)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 15 Apr 2021 (estimated)
- First posted
- 20 Jan 2021 (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.
It should be known by the clinician that COVID-19 patients are prone to anxiety, and these disorders need to be properly diagnosed and addressed to improve prognosis, shorten hospital stay and avoid long-term mental health problems.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospital Anxiety Depression Measure | – | Behavioral: Hospital Anxiety Depression MeasureHospital Anxiety Depression Measure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Co-operative patients over 18 years of age, with COVID PCR + admission to intensive care unit, will be included in the study.
Key inclusion criteria (4 listed)
- Above 18 years old
- COVID PCR +,
- admitted to intensive care,
- conscious, cooperative patients
Key exclusion criteria (5 listed)
- Having hearing and speaking problems,
- Can't speak Turkish or English,
- who do not have the cognitive level to understand and answer the questions,
- Communication problems such as dementia and Alzheimer's,
- patients receiving sedation
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 |
|---|---|---|
| Hospital Anxiety Depression MeasureHospital Anxiety Depression Measure | Behavioural | Hospital Anxiety Depression Measure |
Primary outcome
intensive care Anxiety
Time frame: 3 month
Hospital Anxiety Depression scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Results publication: PubMed 33009668Deng J, Zhou F, Hou W, Silver Z, Wong CY, Chang O, Huang E, Zuo QK. The prevalence of depression, anxiety, and sleep disturbances in COVID-19 patients: a meta-analysis. Ann N Y Acad Sci. 2021 Feb;1486(1):90-111. doi: 10.1111/nyas.14506. Epub 2020 Oct 2.
- Results publication: PubMed 32437679Rogers JP, Chesney E, Oliver D, Pollak TA, McGuire P, Fusar-Poli P, Zandi MS, Lewis G, David AS. Psychiatric and neuropsychiatric presentations associated with severe coronavirus infections: a systematic review and meta-analysis with comparison to the COVID-19 pandemic. Lancet Psychiatry. 2020 Jul;7(7):611-627. doi: 10.1016/S2215-0366(20)30203-0. Epub 2020 May 18.
- Results publication3. Aydemir Ö, Güvenir T, Küey L, Kültür S. Hastane Anksiyete ve Depresyon Ölçeği Türkçe Formunun Geçerlik Güvenilirlik Çalışması. Türk Psikiyatri Dergisi 1997;8:280-287.
- Derived from this study: PubMed 34664224Kupeli I, Kara MY, Yakin I, Caglayan AC. Anxiety and depression in the first 24 h in COVID-19 patients who underwent non-invasive mechanical ventilation in the intensive care unit. Ir J Med Sci. 2022 Oct;191(5):2291-2295. doi: 10.1007/s11845-021-02808-8. Epub 2021 Oct 19.
- Individual participant dataSharing planned: No
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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.
ilke kupeli principal investigator
Derince Training and Research Hospital
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 Anxiety, run by Derince Training and Research Hospital 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 20 Jan 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ilke kupeli (05555485632, ilkeser2004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intensive care Anxiety (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04715477, which also lists 4 linked publications.
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 20 Jan 2021.