InfectionNCT04454333
COVID-19 in Pain Perspective
An observational study of Infection and COVID, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In our hospital's Infectious Diseases and Clinical Microbiology service, patients who have been hospitalized due to Covid -19 infection have a musculoskeletal pain and headache during this process, and 466 patients will be recruited to compare them with the pre-disease state of the patients and to evaluate the pain… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- How many people
- 466 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jun 2020to 20 Jun 2020
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In our hospital, patients who were treated with the diagnosis of COVID-19 were selected. During the selection, patients between the ages of 18-95 were selected, considering the inclusion and exclusion criteria.
Who may be able to join
- Patients with positive PCR test results obtained from combined throat and nasopharyngeal swab samples
- patients consistent with Covid-19 infection as a result of thorax computed tomography, although PCR test results were negative.
Who cannot join
- Patients who have undergone surgery and trauma in the painful area in the past 3 months,
- Patients with pathological disease that can cause underlying pain
- Pregnant women
- Those who have psychiatric illness and use psychiatric drugs
- Presence of malignancy
- Patients with severe cognitive deficits
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Şişli Hamidiye Etfal Training and Research Hospital
Istanbul
About this study
In our hospital's Infectious Diseases and Clinical Microbiology service, patients who have been hospitalized due to Covid -19 infection have a musculoskeletal pain and headache during this process, and 466 patients will be recruited to compare them with the pre-disease state of the patients and to evaluate the pain status of the patients after treatment.
Read the detailed description
This retrospectively designed study was carried out by analyzing SARS-CoV-2 infected and hospitalized patients in our hospital for 2 month. The patients, whose contact information can be accessed from the hospital records, will be called by phone and pain inquiries were made during the SARS-CoV-2 infection process. In addition, patients' demographic data, living conditions (number and characteristics of the person in the household), comorbidities, symptom inquiry related to infection, duration of symptoms, length of hospitalstay, pre-infection pain conditions and current pain, anxiety, depression levels and quality of life will be questioned.
The pain questioning include the painful body region/s, severity (Numeric Rating Scale), type of analgesic drugs used, and duration of use that occurred during infection. Anxiety and depression levels will be evaluated, hospital anxiety and depression scale (HADS), and quality of life will be evaluated with SF-12 health assessment questionnaire.
- Keywords
- infections, pain, Coronavirus
- Medical subject headings
- Infections, Pain, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized caused by COVID-19 | A total of 466 patients hospitalized with the diagnosis of SARS-COV-2 at the University of Health Sciences, Şişli Hamidiye Etfal Training and Research Hospital were retrospectively screened. 212 of these patients did not answer the calls, 34 of them could not be reached because they gave the wrong phone number beforehand. 4 of the patients called by the phone had communication problems due to language problems and 10 people did not want to fill the questionnaire. 206 of them were contacted by the phone and their pain and myalgia in the head, neck-back, waist, shoulder and hip regions before, during and after SARS-COV-2, their anxiety and depression levels after SARS-COV-2, and their quality of life were questioned. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale for Pain
Evaluation of severity of pain for head, back-neck and extremities by Numeric Rating Scale. Scoring will be done between 0 minimum and 10 maximum values. Higher scores mean worse outcome.
Measured: up to 10 weeks
Hospital Anxiety and Depression Scale (HADS)
Evaluation of patient's anxiety and depression level in hospital by Hospital Anxiety and Depression Scale (HADS). The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-report screening scale. It contains two 7-item scales: one for anxiety and one for depression both with a score range of 0-21. Higher scores mean a worse outcome.
Measured: up to 10 weeks
SF-12 Health assesment Questionaire
Evaluation of patient's quality of life by SF-12 Health assesment Questionaire. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). Higher scores mean a better outcome.
Measured: up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start3 Jun 2020
- Primary completion18 Jun 2020
- Study completion20 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 466 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aylin Ayyıldız, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- Aylin Ayyıldız, MD, Principal investigator, Şişli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04454333
- Sponsor's protocol ID
- 2811
- Status last verified
- Jun 2020
- First submitted
- 30 Jun 2020
- Last updated
- 1 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sahin T, Ayyildiz A, Gencer-Atalay K, Akgun C, Ozdemir HM, Kuran B. Pain Symptoms in COVID-19. Am J Phys Med Rehabil. 2021 Apr 1;100(4):307-312. doi: 10.1097/PHM.0000000000001699.
PubMed 33480608
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 in Pain Perspective
- ClinicalTrials.gov ID
- NCT04454333
- Acronym / sponsor ID
- 2811
- Keywords
- infections, pain, Coronavirus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 466 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 3 Jun 2020 (actual)
- Primary completion
- 18 Jun 2020 (actual)
- Study completion
- 20 Jun 2020 (actual)
- First posted
- 1 Jul 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.
In our hospital's Infectious Diseases and Clinical Microbiology service, patients who have been hospitalized due to Covid -19 infection have a musculoskeletal pain and headache during this process, and 466 patients will be recruited to compare them with the pre-disease state of the patients and to evaluate the pain status of the patients after treatment.
Detailed description
This retrospectively designed study was carried out by analyzing SARS-CoV-2 infected and hospitalized patients in our hospital for 2 month. The patients, whose contact information can be accessed from the hospital records, will be called by phone and pain inquiries were made during the SARS-CoV-2 infection process. In addition, patients' demographic data, living conditions (number and characteristics of the person in the household), comorbidities, symptom inquiry related to infection, duration of symptoms, length of hospitalstay, pre-infection pain conditions and current pain, anxiety, depression levels and quality of life will be questioned.
The pain questioning include the painful body region/s, severity (Numeric Rating Scale), type of analgesic drugs used, and duration of use that occurred during infection. Anxiety and depression levels will be evaluated, hospital anxiety and depression scale (HADS), and quality of life will be evaluated with SF-12 health assessment questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospitalized caused by COVID-19 | – | –A total of 466 patients hospitalized with the diagnosis of SARS-COV-2 at the University of Health Sciences, Şişli Hamidiye Etfal Training and Research Hospital were retrospectively screened. 212 of these patients did not answer the calls, 34 of them could not be reached because they gave the wrong phone number beforehand. 4 of the patients called by the phone had communication problems due to language problems and 10 people did not want to fill the questionnaire. 206 of them were contacted by the phone and their pain and myalgia in the head, neck-back, waist, shoulder and hip regions before, during and after SARS-COV-2, their anxiety and depression levels after SARS-COV-2, and their quality of life were questioned. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In our hospital, patients who were treated with the diagnosis of COVID-19 were selected. During the selection, patients between the ages of 18-95 were selected, considering the inclusion and exclusion criteria.
Key inclusion criteria (2 listed)
- Patients with positive PCR test results obtained from combined throat and nasopharyngeal swab samples
- patients consistent with Covid-19 infection as a result of thorax computed tomography, although PCR test results were negative.
Key exclusion criteria (6 listed)
- Patients who have undergone surgery and trauma in the painful area in the past 3 months,
- Patients with pathological disease that can cause underlying pain
- Pregnant women
- Those who have psychiatric illness and use psychiatric drugs
- Presence of malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Numeric Rating Scale for Pain
Time frame: up to 10 weeks
Evaluation of severity of pain for head, back-neck and extremities by Numeric Rating Scale. Scoring will be done between 0 minimum and 10 maximum values. Higher scores mean worse outcome.
Hospital Anxiety and Depression Scale (HADS)
Time frame: up to 10 weeks
Evaluation of patient's anxiety and depression level in hospital by Hospital Anxiety and Depression Scale (HADS). The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-report screening scale. It contains two 7-item scales: one for anxiety and one for depression both with a score range of 0-21. Higher scores mean a worse outcome.
SF-12 Health assesment Questionaire
Time frame: up to 10 weeks
Evaluation of patient's quality of life by SF-12 Health assesment Questionaire. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). Higher scores mean a better outcome.
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 1 Jul 2020.
- Derived from this study: PubMed 33480608Sahin T, Ayyildiz A, Gencer-Atalay K, Akgun C, Ozdemir HM, Kuran B. Pain Symptoms in COVID-19. Am J Phys Med Rehabil. 2021 Apr 1;100(4):307-312. doi: 10.1097/PHM.0000000000001699.
Related trials for Infection
RecruitingPhase 1/2
Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma
Lymphoma, Non-Hodgkin Lymphoma
Not yet recruitingPhase 3
Efficacy and Safety of Minocycline Add-on in Patients With Neurosyphilis
Neurosyphilis
RecruitingObservational study
Study of Mycobacterial Infections
Mycobacterium Infections
RecruitingPhase 2
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1283 in Participants ≥6 Months to <12 Years of Age
SARS-CoV-2
Active, not recruiting
HPV Multilevel Intervention Strategies Targeting Immunization in Community Settings (HPV MISTICS)
Human Papilloma Virus (HPV) Vaccine
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.
Aylin Ayyıldız, MD principal investigator
Şişli Hamidiye Etfal 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 Infection and COVID, run by Sisli Hamidiye Etfal 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 2 inclusion and 6 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 1 Jul 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?
Numeric Rating Scale for Pain (time frame: up to 10 weeks). The study lists 3 primary outcomes in all. 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 NCT04454333, which also lists 1 linked publication.
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 1 Jul 2020.