Post ICU SyndromePAIN-COVIDNCT04394169
Early Care Program for the Management of Post-ICU Syndrome and Chronic Pain After COVID-19 Infection.
A study testing Intervention program in people with Post ICU Syndrome and Chronic Pain, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
COVID-19 (coronavirus 2019) disease has led to a large number of hospital admissions, many of which require admission to intensive care (ICU). Post-intensive care syndrome (PICS) is defined as deterioration or worsening of previous deterioration in the mental, physical or cognitive status that appears as a consequence… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post ICU Syndrome, Chronic Pain, Covid-19
- What is being tested?
- Intervention program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteSpain
- Study dates
- 25 May 2020to 22 Oct 2021
- Phase
- Interventional
- 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
Who may be able to join
- Admitted to the ICU due to COVID infection19.
- APACHE II score> 14 or ICU stay> 10 days or Duration of mechanical ventilation> 7 days or Acquired weakness in ICU or Delirium during ICU admission.
- Accept to participate in the study and sign informed consent.
Who cannot join
- Central Nervous System degenerative diseases. Examples: Alzheimer's disease, Amyotrophic lateral sclerosis, Lewy body dementia, Parkinson's disease, among others.
- Terminal illness: Definition according to the palliative care guide, Spanish Society for Palliative Care. "Advanced, progressive, and incurable disease with a lack of reasonable possibilities of specific treatment, with a life prognosis of less than 6 months.
- Insufficient understanding of the Spanish language.
- Patients in whom it would be difficult to complete follow-up.
- Not having informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Care, Therapeutic Education, and Psychological Intervention for the Management of Post-intensive Care Syndrome and Chronic Pain After Coronavirus Disease 2019 Infection. Simple-blind, Controlled, Randomized Trial.
COVID-19 (coronavirus 2019) disease has led to a large number of hospital admissions, many of which require admission to intensive care (ICU).
Post-intensive care syndrome (PICS) is defined as deterioration or worsening of previous deterioration in the mental, physical or cognitive status that appears as a consequence of a critical illness and which persists after acute hospital care. Also, there is evidence that patients who survive a critical illness have a high prevalence of moderate to extreme chronic pain.
Read more
Patients with COVID-19 disease are an especially susceptible population to develop PICS due to acute respiratory distress syndrome (ARDS) survivors have significant long-term deterioration in mental, cognitive, and functional health.
This study hypothesis is that a specific care program based on early therapeutic education and psychological intervention improves the quality of life of patients at risk of developing PICS and chronic pain after COVID-19 disease.
Read the detailed description
A randomized, controlled, and single-blind trial will be performed. Patients over 18 years who have been admitted to intensive care units with the diagnosis of COVID-19 disease at risk of presenting PICS will be recruited.
The study subjects will be divided into two arms, and the intervention program will be compared to the standard care clinical practice.
The program will consist of early care (first visit at one month of hospital discharge), therapeutic education on prevention and management of PICS and chronic pain during three medical visits in six months, and psychological treatment in patients at risk for emotional distress.
The main objective is to evaluate the impact of the program on health-related life quality at six months after hospital discharge.
The secondary objectives are:
- To assess the health-related life quality at three months after hospital discharge.
- To quantify the incidence of chronic pain, its characteristics, and the degree of functional limitation at three and six months after hospital discharge.
- To quantify the incidence of anxiety and depression at three and six months after hospital discharge.
- Quantify the incidence of post-traumatic stress syndrome at 3 and 6 months after hospital discharge.
- Conditions
- Post ICU Syndrome, Chronic Pain, Covid-19
- Being tested
- Intervention program
- Keywords
- Covid-19, SARS-COV2, Critical Care, Post ICU Syndrome, Chronic Pain, Post-traumatic Stress Disorder, Quality of Life, Depressive Disorders, Anxiety disorders
- Medical subject headings
- Chronic Pain, COVID-19, Stress Disorders, Post-Traumatic, Depressive Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention programBehavioural
Medical visits:
There will be three medical visits stipulated as follows:
- Visit 1 Intervention Group, four weeks after hospital discharge.
- Visit 2 Intervention Group, eight weeks after hospital discharge.
- Visit 3 Intervention Group, 18 weeks after hospital discharge.
Components of visits:
- Interview and physical examination.
- Therapeutic education about the intensive care syndrome orally and with a specific document that will be delivered at the end of the visit.
- Therapeutic education around pain. If the patient reports pain, a specific document will be prepared that will be delivered at the end of the visit.
Psychological intervention:
Inclusion criteria for psychological intervention: Patients with a score higher than 8 on the HAD (hospital anxiety and depression) test depression subscale.
Description :
The intervention protocol consists of 7 weekly sessions lasting one hour and a half. The intervention in depression is based on Rehm's model of self-control.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | The intervention is a program that includes early patient care, therapeutic education, and psychological intervention. It will be performed through three medical visits and a psychological intervention that requires seven face-to-face sessions. Receives: Behavioral: Intervention program |
| Standard care arm | No intervention | Standard medical practice: patient follow-up is carried out by their referring physicians (primary care physicians or specialists) who are outside the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of intervention program on health-related quality of life (VAS)
Health-related quality of life reported by the patient assessed through the visual analogue scale of the EQoL 5D/5L questionnaire at six months after discharge.
[European quality of life 5 dimensions/5 levels ; from 0 (the worst imaginable health) to 100 (the best imaginable health) ]
Measured: Six months after discharge
Secondary outcomes (8)
Impact of intervention program on health-related quality of life (VAS)
Health-related quality of life reported by the patient assessed through the visual analogue scale of the EQoL 5D / 5L questionnaire at three months after discharge.
[European quality of life 5 dimensions/5 levels ; from 0 (the worst imaginable health) to 100 (the best imaginable health)]
Measured: Three months after discharge.
Impact of intervention program on health-related quality of life (Index)
Health-related quality of life reported by the patient assessed through health index of the EQoL 5D/5L questionnaire at three months after discharge.
[European quality of life 5 dimensions/5 levels ; the questionnaire assesses quality of life in study participants according to 5 domains (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each scored according to a scale of 1 (no problems) to 5 (indicating extreme problems) and generating a 5-digit code corresponding to quality of life]
Measured: Three months after discharge
Impact of intervention program on health-related quality of life (Index)
Health-related quality of life reported by the patient assessed through health index of the EQoL 5D/5L questionnaire at six months after discharge.
[European quality of life 5 dimensions/5 levels ; the questionnaire assesses quality of life in study participants according to 5 domains (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each scored according to a scale of 1 (no problems) to 5 (indicating extreme problems) and generating a 5-digit code corresponding to quality of life]
Measured: Six months after discharge
Impact of intervention program on chronic pain (intensity)
Chronic pain intensity defined by BPI questionnaire (short version), at three and six months after discharge.
[Brief pain inventory; A multidimensional questionnaire that evaluates pain intensity in the last 24 hours (worst, lowest, average) and current (right now). The questions are rated on a scale of 0 to 10, with 10 being the worst possible value. Subsequently, the average intensity score (BPI intensity score) is calculated.]
Measured: Three and six months after discharge.
Impact of intervention program on chronic pain (limitation of daily activities)
Limitation of daily activities due to chronic pain, defined by BPI (short version), at three and six months after discharge.
[Brief pain inventory; Multidimensional questionnaire that assesses the impact of pain on daily activities (general activity, encouragement, work, relationships with other people, sleep, enjoying life and the ability to walk). The questions are rated on a scale of 0 to 10, with 10 being the worst possible value. Subsequently, the mean score of the responses related to pain interference in activities (BPI interference score) is calculated.]
Measured: Three and six months after discharge.
Impact of intervention program on chronic pain (Pain catastrophization)
Pain catastrophization assessed by Pain Catastrophizing Scale at three and six months after hospital discharge.
[Pain Catastrophizing Scale; Consisting of 13 questions that explore the frequency of thoughts and feelings that the interviewees have in the presence of current or anticipated pain, which are grouped into three scoring subscales (magnification, rumination and defenselessness). Each question is rated on a 5-point scale (0: not at all; 4: all the time). Being the maximum total score of 52 points.]
Measured: Three and six months after discharge.
Impact of intervention program on anxiety or depression incidence
Clinically significant anxiety or depression symptoms prevalence at three and six months, assessed by the HAD test.
[hospital anxiety and depression test; 14 questions, with two subscales, one for anxiety and the other for depression, with seven items each, the maximum score is 21 for each subscale. The cut-off points from zero to seven imply the absence of clinically relevant anxiety and depression, from eight to ten symptoms that require consideration and from 11 to 21 reports the presence of relevant symptoms, with a very probable diagnosis of anxiety or depression.]
Measured: Three and six months after discharge.
Impact of intervention on probable post-traumatic stress syndrome incidence
Probable post-traumatic stress syndrome prevalence at three and six months after discharge assessed by the DSM ( Diagnostic and Statistical Manual of Mental Disorders) V PTSD Checklist questionnaire (PCL-5)
[PTSD Checklist questionnaire; It contains 20 questions that correspond to the DSM V PTSD (Post Traumatic Stress Disorder) criteria. Participants rated their symptoms on a scale of 0 (not at all), 1 (slightly), 2 (moderately), 3 (quite) to 4 (extremely), with a score ranging from 0 to 80. A total of the severity of the symptoms can be made, adding the score of each question (interval 0-80). The severity of each symptom can be evaluated, adding the score of the questions. The cut-off point to use for a provisional diagnosis of PTSD is 31 points.]
Measured: Three and six months after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start25 May 2020
- Primary completion15 Oct 2021
- Study completion22 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Post ICU SyndromeStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, single-blind, and single-center clinical trial that will include patients who have been admitted to intensive care of our hospital due to COVID-19 disease.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TOMAS MIGUEL CUÑAT LOPEZ, Hospital Clinic of Barcelona
- Investigators
- Antonio José Ojeda Niño, MD, Principal investigator, Pain unit physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04394169
- Sponsor's protocol ID
- HCB/2020/0549
- Acronym
- PAIN-COVID
- Status last verified
- Dec 2021
- First submitted
- 13 May 2020
- Last updated
- 14 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24.
PubMed 32105632Mao L, Jin H, Wang M, Hu Y, Chen S, He Q, Chang J, Hong C, Zhou Y, Wang D, Miao X, Li Y, Hu B. Neurologic Manifestations of Hospitalized Patients With Coronavirus Disease 2019 in Wuhan, China. JAMA Neurol. 2020 Jun 1;77(6):683-690. doi: 10.1001/jamaneurol.2020.1127.
PubMed 32275288Boldrini P, Bernetti A, Fiore P; SIMFER Executive Committee, SIMFER Committee for International Affairs. Impact of COVID-19 outbreak on rehabilitation services and Physical and Rehabilitation Medicine physicians' activities in Italy. An official document of the Italian PRM Society (SIMFER). Eur J Phys Rehabil Med. 2020 Jun;56(3):316-318. doi: 10.23736/S1973-9087.20.06256-5. Epub 2020 Mar 16. No abstract available.
PubMed 32175719Griffiths J, Hatch RA, Bishop J, Morgan K, Jenkinson C, Cuthbertson BH, Brett SJ. An exploration of social and economic outcome and associated health-related quality of life after critical illness in general intensive care unit survivors: a 12-month follow-up study. Crit Care. 2013 May 28;17(3):R100. doi: 10.1186/cc12745.
PubMed 23714692Torres J, Carvalho D, Molinos E, Vales C, Ferreira A, Dias CC, Araujo R, Gomes E. The impact of the patient post-intensive care syndrome components upon caregiver burden. Med Intensiva. 2017 Nov;41(8):454-460. doi: 10.1016/j.medin.2016.12.005. Epub 2017 Feb 8. English, Spanish.
PubMed 28188064Elliott D, Davidson JE, Harvey MA, Bemis-Dougherty A, Hopkins RO, Iwashyna TJ, Wagner J, Weinert C, Wunsch H, Bienvenu OJ, Black G, Brady S, Brodsky MB, Deutschman C, Doepp D, Flatley C, Fosnight S, Gittler M, Gomez BT, Hyzy R, Louis D, Mandel R, Maxwell C, Muldoon SR, Perme CS, Reilly C, Robinson MR, Rubin E, Schmidt DM, Schuller J, Scruth E, Siegal E, Spill GR, Sprenger S, Straumanis JP, Sutton P, Swoboda SM, Twaddle ML, Needham DM. Exploring the scope of post-intensive care syndrome therapy and care: engagement of non-critical care providers and survivors in a second stakeholders meeting. Crit Care Med. 2014 Dec;42(12):2518-26. doi: 10.1097/CCM.0000000000000525.
PubMed 25083984Hayhurst CJ, Jackson JC, Archer KR, Thompson JL, Chandrasekhar R, Hughes CG. Pain and Its Long-term Interference of Daily Life After Critical Illness. Anesth Analg. 2018 Sep;127(3):690-697. doi: 10.1213/ANE.0000000000003358.
PubMed 29649027Battle CE, Lovett S, Hutchings H. Chronic pain in survivors of critical illness: a retrospective analysis of incidence and risk factors. Crit Care. 2013 May 29;17(3):R101. doi: 10.1186/cc12746.
PubMed 23718685Ojeda A, Cunat T, Comino-Trinidad O, Aliaga J, Arias M, Calvo A. New-onset chronic and neuropathic pain in survivors of severe COVID-19: A secondary analysis of the PAIN-COVID Trial. Rev Esp Anestesiol Reanim (Engl Ed). 2025 Dec;72(10):501915. doi: 10.1016/j.redare.2025.501915. Epub 2025 Sep 23.
PubMed 40998165Ojeda A, Calvo A, Cunat T, Mellado-Artigas R, Costas-Carrera A, Sanchez-Rodriguez MM, Comino-Trinidad O, Aliaga J, Arias M, Martinez-Palli G, Dursteler C, Ferrando C. Effectiveness of a specific follow up program for the management of the mental components of post-intensive care syndrome and chronic pain after COVID-19: results from the PAIN-COVID randomized clinical trial. Rev Esp Anestesiol Reanim (Engl Ed). 2024 May;71(5):349-359. doi: 10.1016/j.redare.2023.12.009. Epub 2024 Jan 17.
PubMed 38242358Ojeda A, Calvo A, Cunat T, Mellado-Artigas R, Comino-Trinidad O, Aliaga J, Arias M, Ferrando C, Martinez-Palli G, Dursteler C. Characteristics and influence on quality of life of new-onset pain in critical COVID-19 survivors. Eur J Pain. 2022 Mar;26(3):680-694. doi: 10.1002/ejp.1897. Epub 2021 Dec 15.
PubMed 34866276Ojeda A, Calvo A, Cunat T, Artigas RM, Comino-Trinidad O, Aliaga J, Arias M, Ahuir M, Ferrando C, Dursteler C. Rationale and study design of an early care, therapeutic education, and psychological intervention program for the management of post-intensive care syndrome and chronic pain after COVID-19 infection (PAIN-COVID): study protocol for a randomized controlled trial. Trials. 2021 Jul 24;22(1):486. doi: 10.1186/s13063-021-05463-7.
PubMed 34303381
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Care, Therapeutic Education, and Psychological Intervention for the Management of Post-intensive Care Syndrome and Chronic Pain After Coronavirus Disease 2019 Infection. Simple-blind, Controlled, Randomized Trial.
- ClinicalTrials.gov ID
- NCT04394169
- Acronym / sponsor ID
- PAIN-COVID / HCB/2020/0549
- Conditions
- Post ICU Syndrome, Chronic Pain, Covid-19
- Keywords
- Covid-19, SARS-COV2, Critical Care, Post ICU Syndrome, Chronic Pain, Post-traumatic Stress Disorder, Quality of Life, Depressive Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 25 May 2020 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 22 Oct 2021 (actual)
- First posted
- 19 May 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.
COVID-19 (coronavirus 2019) disease has led to a large number of hospital admissions, many of which require admission to intensive care (ICU).
Post-intensive care syndrome (PICS) is defined as deterioration or worsening of previous deterioration in the mental, physical or cognitive status that appears as a consequence of a critical illness and which persists after acute hospital care. Also, there is evidence that patients who survive a critical illness have a high prevalence of moderate to extreme chronic pain.
Patients with COVID-19 disease are an especially susceptible population to develop PICS due to acute respiratory distress syndrome (ARDS) survivors have significant long-term deterioration in mental, cognitive, and functional health.
This study hypothesis is that a specific care program based on early therapeutic education and psychological intervention improves the quality of life of patients at risk of developing PICS and chronic pain after COVID-19 disease.
Detailed description
A randomized, controlled, and single-blind trial will be performed. Patients over 18 years who have been admitted to intensive care units with the diagnosis of COVID-19 disease at risk of presenting PICS will be recruited.
The study subjects will be divided into two arms, and the intervention program will be compared to the standard care clinical practice.
The program will consist of early care (first visit at one month of hospital discharge), therapeutic education on prevention and management of PICS and chronic pain during three medical visits in six months, and psychological treatment in patients at risk for emotional distress.
The main objective is to evaluate the impact of the program on health-related life quality at six months after hospital discharge.
The secondary objectives are:
- To assess the health-related life quality at three months after hospital discharge.
- To quantify the incidence of chronic pain, its characteristics, and the degree of functional limitation at three and six months after hospital discharge.
- To quantify the incidence of anxiety and depression at three and six months after hospital discharge.
- Quantify the incidence of post-traumatic stress syndrome at 3 and 6 months after hospital discharge.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomized, controlled, single-blind, and single-center clinical trial that will include patients who have been admitted to intensive care of our hospital due to COVID-19 disease.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Intervention programThe intervention is a program that includes early patient care, therapeutic education, and psychological intervention. It will be performed through three medical visits and a psychological intervention that requires seven face-to-face sessions. |
| Standard care arm | No intervention | –Standard medical practice: patient follow-up is carried out by their referring physicians (primary care physicians or specialists) who are outside the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Admitted to the ICU due to COVID infection19.
- APACHE II score> 14 or ICU stay> 10 days or Duration of mechanical ventilation> 7 days or Acquired weakness in ICU or Delirium during ICU admission.
- Accept to participate in the study and sign informed consent.
Key exclusion criteria (5 listed)
- Central Nervous System degenerative diseases. Examples: Alzheimer's disease, Amyotrophic lateral sclerosis, Lewy body dementia, Parkinson's disease, among others.
- Terminal illness: Definition according to the palliative care guide, Spanish Society for Palliative Care. "Advanced, progressive, and incurable disease with a lack of reasonable possibilities of specific treatment, with a life prognosis of less than 6 months.
- Insufficient understanding of the Spanish language.
- Patients in whom it would be difficult to complete follow-up.
- Not having informed consent.
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 |
|---|---|---|
| Intervention programMedical visits: There will be three medical visits stipulated as follows: * Visit 1 Intervention Group, four weeks after hospital discharge. * Visit 2 Intervention Group, eight weeks after hospital discharge. * Visit 3 Intervention Group, 18 weeks after hospital discharge. Components of visits: * Interview and physical examination. * Therapeutic education about the intensive care syndrome orally and with a specific document that will be delivered at the end of the visit. * Therapeutic education around pain. If the patient reports pain, a specific document will be prepared that will be delivered at the end of the visit. Psychological intervention: Inclusion criteria for psychological intervention: Patients with a score higher than 8 on the HAD (hospital anxiety and depression) test depression subscale. Description : The intervention protocol consists of 7 weekly sessions lasting one hour and a half. The intervention in depression is based on Rehm's model of self-control. | Behavioural | Intervention arm |
Primary outcome
Impact of intervention program on health-related quality of life (VAS)
Time frame: Six months after discharge
Health-related quality of life reported by the patient assessed through the visual analogue scale of the EQoL 5D/5L questionnaire at six months after discharge. [European quality of life 5 dimensions/5 levels ; from 0 (the worst imaginable health) to 100 (the best imaginable health) ]
8 secondary outcomes
Impact of intervention program on health-related quality of life (VAS)
Time frame: Three months after discharge.
Impact of intervention program on health-related quality of life (Index)
Time frame: Three months after discharge
Impact of intervention program on health-related quality of life (Index)
Time frame: Six months after discharge
Impact of intervention program on chronic pain (intensity)
Time frame: Three and six months after discharge.
Impact of intervention program on chronic pain (limitation of daily activities)
Time frame: Three and six months after discharge.
Impact of intervention program on chronic pain (Pain catastrophization)
Time frame: Three and six months after discharge.
Impact of intervention program on anxiety or depression incidence
Time frame: Three and six months after discharge.
Impact of intervention on probable post-traumatic stress syndrome incidence
Time frame: Three and six months after discharge.
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 14 Dec 2021.
- Background: PubMed 32105632Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24.
- Background: PubMed 32275288Mao L, Jin H, Wang M, Hu Y, Chen S, He Q, Chang J, Hong C, Zhou Y, Wang D, Miao X, Li Y, Hu B. Neurologic Manifestations of Hospitalized Patients With Coronavirus Disease 2019 in Wuhan, China. JAMA Neurol. 2020 Jun 1;77(6):683-690. doi: 10.1001/jamaneurol.2020.1127.
- Background: PubMed 32175719Boldrini P, Bernetti A, Fiore P; SIMFER Executive Committee, SIMFER Committee for International Affairs. Impact of COVID-19 outbreak on rehabilitation services and Physical and Rehabilitation Medicine physicians' activities in Italy. An official document of the Italian PRM Society (SIMFER). Eur J Phys Rehabil Med. 2020 Jun;56(3):316-318. doi: 10.23736/S1973-9087.20.06256-5. Epub 2020 Mar 16. No abstract available.
- Background: PubMed 23714692Griffiths J, Hatch RA, Bishop J, Morgan K, Jenkinson C, Cuthbertson BH, Brett SJ. An exploration of social and economic outcome and associated health-related quality of life after critical illness in general intensive care unit survivors: a 12-month follow-up study. Crit Care. 2013 May 28;17(3):R100. doi: 10.1186/cc12745.
- Background: PubMed 28188064Torres J, Carvalho D, Molinos E, Vales C, Ferreira A, Dias CC, Araujo R, Gomes E. The impact of the patient post-intensive care syndrome components upon caregiver burden. Med Intensiva. 2017 Nov;41(8):454-460. doi: 10.1016/j.medin.2016.12.005. Epub 2017 Feb 8. English, Spanish.
- Background: PubMed 25083984Elliott D, Davidson JE, Harvey MA, Bemis-Dougherty A, Hopkins RO, Iwashyna TJ, Wagner J, Weinert C, Wunsch H, Bienvenu OJ, Black G, Brady S, Brodsky MB, Deutschman C, Doepp D, Flatley C, Fosnight S, Gittler M, Gomez BT, Hyzy R, Louis D, Mandel R, Maxwell C, Muldoon SR, Perme CS, Reilly C, Robinson MR, Rubin E, Schmidt DM, Schuller J, Scruth E, Siegal E, Spill GR, Sprenger S, Straumanis JP, Sutton P, Swoboda SM, Twaddle ML, Needham DM. Exploring the scope of post-intensive care syndrome therapy and care: engagement of non-critical care providers and survivors in a second stakeholders meeting. Crit Care Med. 2014 Dec;42(12):2518-26. doi: 10.1097/CCM.0000000000000525.
- Background: PubMed 29649027Hayhurst CJ, Jackson JC, Archer KR, Thompson JL, Chandrasekhar R, Hughes CG. Pain and Its Long-term Interference of Daily Life After Critical Illness. Anesth Analg. 2018 Sep;127(3):690-697. doi: 10.1213/ANE.0000000000003358.
- Background: PubMed 23718685Battle CE, Lovett S, Hutchings H. Chronic pain in survivors of critical illness: a retrospective analysis of incidence and risk factors. Crit Care. 2013 May 29;17(3):R101. doi: 10.1186/cc12746.
- Derived from this study: PubMed 40998165Ojeda A, Cunat T, Comino-Trinidad O, Aliaga J, Arias M, Calvo A. New-onset chronic and neuropathic pain in survivors of severe COVID-19: A secondary analysis of the PAIN-COVID Trial. Rev Esp Anestesiol Reanim (Engl Ed). 2025 Dec;72(10):501915. doi: 10.1016/j.redare.2025.501915. Epub 2025 Sep 23.
- Derived from this study: PubMed 38242358Ojeda A, Calvo A, Cunat T, Mellado-Artigas R, Costas-Carrera A, Sanchez-Rodriguez MM, Comino-Trinidad O, Aliaga J, Arias M, Martinez-Palli G, Dursteler C, Ferrando C. Effectiveness of a specific follow up program for the management of the mental components of post-intensive care syndrome and chronic pain after COVID-19: results from the PAIN-COVID randomized clinical trial. Rev Esp Anestesiol Reanim (Engl Ed). 2024 May;71(5):349-359. doi: 10.1016/j.redare.2023.12.009. Epub 2024 Jan 17.
- Derived from this study: PubMed 34866276Ojeda A, Calvo A, Cunat T, Mellado-Artigas R, Comino-Trinidad O, Aliaga J, Arias M, Ferrando C, Martinez-Palli G, Dursteler C. Characteristics and influence on quality of life of new-onset pain in critical COVID-19 survivors. Eur J Pain. 2022 Mar;26(3):680-694. doi: 10.1002/ejp.1897. Epub 2021 Dec 15.
- Derived from this study: PubMed 34303381Ojeda A, Calvo A, Cunat T, Artigas RM, Comino-Trinidad O, Aliaga J, Arias M, Ahuir M, Ferrando C, Dursteler C. Rationale and study design of an early care, therapeutic education, and psychological intervention program for the management of post-intensive care syndrome and chronic pain after COVID-19 infection (PAIN-COVID): study protocol for a randomized controlled trial. Trials. 2021 Jul 24;22(1):486. doi: 10.1186/s13063-021-05463-7.
- Individual participant dataSharing planned: No
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ARDS, ARDS Disease Progression
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Feasibility Study on the Use of a Walking Exoskeleton in the Intensive Care Unit
Neuromuscular Disease in Post-Intensive Care Syndrome
Not yet recruiting
Family-partnered Delirium Prevention, Detection, and Management in the ICU
Delirium, Intensive Care Unit Delirium
Not yet recruitingObservational study
Cumulative Intra-Abdominal Pressure Burden and Acute Kidney Injury After Emergency Abdominal Surgery
Acute Kidney Injury, Intra-Abdominal Hypertension
Not yet recruitingObservational study
PICS-p Longitudinal Cohort Study
Physical Functional Impairment, Cognitive Impairment
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.
Antonio José Ojeda Niño, MD principal investigator
Pain unit physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention program in people with Post ICU Syndrome and Chronic Pain, run by Hospital Clinic of Barcelona 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 3 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: finished, as of the sponsor's last update on 14 Dec 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 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?
Impact of intervention program on health-related quality of life (VAS) (time frame: Six months after discharge). 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 NCT04394169, which also lists 12 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 14 Dec 2021.