ICU Ill PatientsCARE-ICUNCT07153380
Evolution of Physical and Emotional Distress in ICU
An observational study of ICU Ill Patients and Critical Illness, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
Emotional distress is prevalent in ICU patients and may be influenced by physical symptoms such as dyspnea and pain, yet its evolution and interactions during ICU stay remain insufficiently explored. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU Ill Patients, Critical Illness
- How many people
- 62 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2018to 15 Sep 2024
- 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: ICU patients admitted to Parc Taulí Hospital
Who may be able to join
- ≥ 18 years old
- Admitted to the ICU for at least ≥ 24 hours
Who cannot join
- Previous cognitive impairment or dementia
- Prior history of neurological disease (including brain damage at admission)
- Severe psychiatric disorder (including substance use disorder)
- Intellectual disability
- Non-Spanish speaker
- Life expentancy <12 months
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site
I3PT Instituto de Investigación e Innovación Parc Taulí
Sabadell, Barcelona, 08208
About this study
Official title: Critical Assessment of Respiratory, Physical and Emotional Distress in Critically Ill Patients With and Without Invasive Mechanical Ventilation
Emotional distress is prevalent in ICU patients and may be influenced by physical symptoms such as dyspnea and pain, yet its evolution and interactions during ICU stay remain insufficiently explored. The main objective of this study is to investigate the trajectory of anxiety, sadness, dyspnea, and pain during ICU stay, as well as their associations with clinical and demographic factors. Moreover, the investigators will study the impact of emotional distress during ICU admission in the cognitive status of the ICU survivors at discharge.
In this study the investigators will recover the data of 62 ICU patients who participated in 3 different studies lead by the research line of Characterization and Managment of the Post-Intensive Care Syndrome from the I3PT research Group of Translational Research in the Physiopathology of the Critically Ill Patients. In the 3 studies, emotional distress (anxiety and sadness), dyspnea, and pain were evaluated daily using visual analog scales once adequate consciousness was achieved (RASS -1 to +1). Cognitive status at ICU discharge was assessed using the Montreal Cognitive Assessment (MoCA). The datasets of the 3 studies will be revised and a new database will be generated with participants who have an assessment of emotional distress for at least 80% of the ICU length of stay with an optimal level of consciousness (RASS >-1). New mixed-effects models will be used to explore the evolution of emotional and physical distress during ICU admission and the associations with invasive mechanical ventilation (IMV), and other demographic and clinical variables. Expected results: the investigators expect a better understanding of the evolution of anxiety and sadness symptoms during ICU stay and its relationship with the level of dyspnea and pain experienced by the critically ill patients during admission.
- Conditions
- ICU Ill Patients, Critical Illness
- Keywords
- ICU patients, dypnea, emotional state ICU, pain, ICU physical distress, ICU emotional distress, ICU admission
- Medical subject headings
- Critical Illness, Pain
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 |
|---|---|---|
| CARE-ICU | Critically ill patients during ICU admission |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotional distress
Daily levels of anxiety and depression symptoms- Assessed by Visual Analog Scale (VAS).
The assessment is carried out once the admitted critically ill patient reaches a minimum level of consciousness (Richmond Agitation Sedation Scale ≥-1).
Measured: During ICU admission
Physical distress
Daily levels of dyspnea and pain. - Assessed by Visual Analog Scale (VAS). The assessment is carried out once the admitted critically ill patient reaches a minimum level of consciousness (Richmond Agitation Sedation Scale ≥-1).
Measured: During ICU admission
Secondary outcomes (1)
Cognitive status
MoCA test
Measured: From the first documented data on discharge from the ICU for the first subject included in the study, to the last documented data on discharge from the ICU for the last patient included in the study, evaluated up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start1 Nov 2018
- Primary completion14 Sep 2024
- Study completion15 Sep 2024
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 ICU Ill PatientsStudies 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
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisabet Doña-López, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07153380
- Sponsor's protocol ID
- 2025/5057
- Acronym
- CARE-ICU
- Status last verified
- Aug 2025
- First submitted
- 29 Jul 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dona-Lopez E, Godoy-Gonzalez M, Navarra-Ventura G, Fernandez-Olivares A, Goma G, Estela Esteve J, De Haro C, Diaz Santos E, Salarbous L, Jodar M, Blanch L, Lopez-Aguilar J, Fernandez-Gonzalo S. Trajectories of emotional and physical distress during ICU stay and their association with clinical factors and cognitive status at discharge. Sci Rep. 2026 Jan 27;16(1):6281. doi: 10.1038/s41598-026-36684-y.
PubMed 41588070
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Critical Assessment of Respiratory, Physical and Emotional Distress in Critically Ill Patients With and Without Invasive Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT07153380
- Acronym / sponsor ID
- CARE-ICU / 2025/5057
- Conditions
- ICU Ill Patients, Critical Illness
- Keywords
- ICU patients, dypnea, emotional state ICU, pain, ICU physical distress, ICU emotional distress, ICU admission
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 14 Sep 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 4 Sep 2025 (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.
Emotional distress is prevalent in ICU patients and may be influenced by physical symptoms such as dyspnea and pain, yet its evolution and interactions during ICU stay remain insufficiently explored. The main objective of this study is to investigate the trajectory of anxiety, sadness, dyspnea, and pain during ICU stay, as well as their associations with clinical and demographic factors. Moreover, the investigators will study the impact of emotional distress during ICU admission in the cognitive status of the ICU survivors at discharge.
In this study the investigators will recover the data of 62 ICU patients who participated in 3 different studies lead by the research line of Characterization and Managment of the Post-Intensive Care Syndrome from the I3PT research Group of Translational Research in the Physiopathology of the Critically Ill Patients. In the 3 studies, emotional distress (anxiety and sadness), dyspnea, and pain were evaluated daily using visual analog scales once adequate consciousness was achieved (RASS -1 to +1). Cognitive status at ICU discharge was assessed using the Montreal Cognitive Assessment (MoCA). The datasets of the 3 studies will be revised and a new database will be generated with participants who have an assessment of emotional distress for at least 80% of the ICU length of stay with an optimal level of consciousness (RASS >-1). New mixed-effects models will be used to explore the evolution of emotional and physical distress during ICU admission and the associations with invasive mechanical ventilation (IMV), and other demographic and clinical variables. Expected results: the investigators expect a better understanding of the evolution of anxiety and sadness symptoms during ICU stay and its relationship with the level of dyspnea and pain experienced by the critically ill patients during admission.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CARE-ICU | – | –Critically ill patients during ICU admission |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patients admitted to Parc Taulí Hospital
Key inclusion criteria (2 listed)
- ≥ 18 years old
- Admitted to the ICU for at least ≥ 24 hours
Key exclusion criteria (7 listed)
- Previous cognitive impairment or dementia
- Prior history of neurological disease (including brain damage at admission)
- Severe psychiatric disorder (including substance use disorder)
- Intellectual disability
- Non-Spanish speaker
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
Emotional distress
Time frame: During ICU admission
Daily levels of anxiety and depression symptoms- Assessed by Visual Analog Scale (VAS). The assessment is carried out once the admitted critically ill patient reaches a minimum level of consciousness (Richmond Agitation Sedation Scale ≥-1).
Physical distress
Time frame: During ICU admission
Daily levels of dyspnea and pain. - Assessed by Visual Analog Scale (VAS). The assessment is carried out once the admitted critically ill patient reaches a minimum level of consciousness (Richmond Agitation Sedation Scale ≥-1).
1 secondary outcome
Cognitive status
Time frame: From the first documented data on discharge from the ICU for the first subject included in the study, to the last documented data on discharge from the ICU for the last patient included in the study, evaluated up to 24 months.
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 4 Sep 2025.
- Derived from this study: PubMed 41588070Dona-Lopez E, Godoy-Gonzalez M, Navarra-Ventura G, Fernandez-Olivares A, Goma G, Estela Esteve J, De Haro C, Diaz Santos E, Salarbous L, Jodar M, Blanch L, Lopez-Aguilar J, Fernandez-Gonzalo S. Trajectories of emotional and physical distress during ICU stay and their association with clinical factors and cognitive status at discharge. Sci Rep. 2026 Jan 27;16(1):6281. doi: 10.1038/s41598-026-36684-y.
- 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 ICU Ill Patients and Critical Illness, run by Corporacion Parc Tauli 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 7 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 4 Sep 2025. 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?
Emotional distress (time frame: During ICU admission). 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?
On the ClinicalTrials.gov record for NCT07153380, 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 4 Sep 2025.