Chronic PainNCT04887220
Persistent Pain and Its Impact on Quality of Life COVID-19 Patients That Required Critical Care
An observational study of Chronic Pain and Post ICU Syndrome, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
COVID-19 infection produces thousands of hospital admissions in a very short period of time, including critical care patients. It is expected that those who survive a severe spectrum of the disease, will present some degree of health decline in the medium and long term, becoming chronic patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Post ICU Syndrome, Quality of Life
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 15 Feb 2021to 1 Mar 2023
- 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: Adults survivors after critical state of COVID 19, who requires critical care.
Who may be able to join
- Post ICU COVID 19 Survivor
- Adult 18 year or older, who gives its approval to participate
Who cannot join
- Refusal to participate
- Neurological or physical secuale, disabled to answer a questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Persistent Pain and Its Impact on Quality of Life at 3, 6 and 12 Months in COVID-19 Patients Who Have Required Critical Care
COVID-19 infection produces thousands of hospital admissions in a very short period of time, including critical care patients. It is expected that those who survive a severe spectrum of the disease, will present some degree of health decline in the medium and long term, becoming chronic patients.
Post-intensive care syndrome (PICS) was described by the Society of Critical Care Medicine (SCCM) as a new altered or worsening of physical, cognitive, or mental condition due to critical illness and persisting after hospitalization, including pain. Also, clinical features of infection include different types of pain, and if this pain persists, it can turn into a chronic condition. Chronic pain is a currently recognized disease, but under-treated in many cases, generating a significant deterioration in the quality of life of this patient. It is vitally important to generate early care circuits to detect and treat those expected complications, such as chronic pain in these patients. The objective of this study is to estimate the level of persistent pain and its impact on health-related quality of life after admission to an intensive care unit in patients who suffered this infection.
Read the detailed description
The presence of persistent pain and impaired quality of life in COVID19 patients who have required intensive care can affect up to a total of 50% of patients.
Main objective Estimate the level of persistent pain and health-related quality of life after admission one in intensive care unit in COVID-19 patients, a new disease that has been accompanied by great health, social and economic involvement from which we do not know the long-term consequences in this patient cohort.
Secondary goals
- Assessing patient's characteristics before ICU admissión; the prevalence of painkillers use, including opioids, history of previous pain, and comorbidities. Find relationships between these characteristics and the development of chronic pain.
- Determine if some ICU treatments and patient's characteristics may contribute to persistent pain in COVID-19 survivors ( number of prone therapies, thromboembolic complications, and medication for sedate used)
- Determine the quality of life using the SF-12 test.
- Determine pain characteristics using the ID-PAIN test.
- Determine the scale of anxiety and depression using the HADs test.
- Conditions
- Chronic Pain, Post ICU Syndrome, Quality of Life
- Medical subject headings
- Chronic Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS scale value
Chronic pain in PostICU COVID19 survivors, measured by VAS scale from Brief Pain Inventory Questionnaire
Measured: 1 year
Secondary outcomes (3)
Quality of life score
Quality of life assessment by SF-12 questionnarie, of ICU survivors after 12 months of ICU discharge
Measured: 1 year
ID Pain test value
Pain characteristics of ICU COVID 19 survivors, using ID PAIN test for presence of neuropathic pain
Measured: 1 year
HAD scale value
Level of anxiety and/or depression in post ICU survivors of COVID 19 at 12 months after discharge, using HAD questionnarie
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start15 Feb 2021
- Primary completion31 May 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04887220
- Sponsor's protocol ID
- IIBSP-COV-2020-63
- Status last verified
- Mar 2023
- First submitted
- 21 Jan 2021
- Last updated
- 7 Mar 2023
- 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 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistent Pain and Its Impact on Quality of Life at 3, 6 and 12 Months in COVID-19 Patients Who Have Required Critical Care
- ClinicalTrials.gov ID
- NCT04887220
- Acronym / sponsor ID
- IIBSP-COV-2020-63
- Conditions
- Chronic Pain, Post ICU Syndrome, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 14 May 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.
COVID-19 infection produces thousands of hospital admissions in a very short period of time, including critical care patients. It is expected that those who survive a severe spectrum of the disease, will present some degree of health decline in the medium and long term, becoming chronic patients.
Post-intensive care syndrome (PICS) was described by the Society of Critical Care Medicine (SCCM) as a new altered or worsening of physical, cognitive, or mental condition due to critical illness and persisting after hospitalization, including pain. Also, clinical features of infection include different types of pain, and if this pain persists, it can turn into a chronic condition. Chronic pain is a currently recognized disease, but under-treated in many cases, generating a significant deterioration in the quality of life of this patient. It is vitally important to generate early care circuits to detect and treat those expected complications, such as chronic pain in these patients. The objective of this study is to estimate the level of persistent pain and its impact on health-related quality of life after admission to an intensive care unit in patients who suffered this infection.
Detailed description
The presence of persistent pain and impaired quality of life in COVID19 patients who have required intensive care can affect up to a total of 50% of patients.
Main objective Estimate the level of persistent pain and health-related quality of life after admission one in intensive care unit in COVID-19 patients, a new disease that has been accompanied by great health, social and economic involvement from which we do not know the long-term consequences in this patient cohort.
Secondary goals
- Assessing patient's characteristics before ICU admissión; the prevalence of painkillers use, including opioids, history of previous pain, and comorbidities. Find relationships between these characteristics and the development of chronic pain.
- Determine if some ICU treatments and patient's characteristics may contribute to persistent pain in COVID-19 survivors ( number of prone therapies, thromboembolic complications, and medication for sedate used)
- Determine the quality of life using the SF-12 test.
- Determine pain characteristics using the ID-PAIN test.
- Determine the scale of anxiety and depression using the HADs test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults survivors after critical state of COVID 19, who requires critical care.
Key inclusion criteria (2 listed)
- Post ICU COVID 19 Survivor
- Adult 18 year or older, who gives its approval to participate
Key exclusion criteria (2 listed)
- Refusal to participate
- Neurological or physical secuale, disabled to answer a questionnaire
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
VAS scale value
Time frame: 1 year
Chronic pain in PostICU COVID19 survivors, measured by VAS scale from Brief Pain Inventory Questionnaire
3 secondary outcomes
Quality of life score
Time frame: 1 year
ID Pain test value
Time frame: 1 year
HAD scale value
Time frame: 1 year
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 7 Mar 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Chronic Pain and Post ICU Syndrome, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 2 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 7 Mar 2023. 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 Spain. 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?
VAS scale value (time frame: 1 year). 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 7 Mar 2023.