Evolution of Physical and Emotional Distress in ICU

NCT07153380 | Completed

• 1 other identifier: 2025/5057
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  During ICU admission

Secondary Outcomes (1)

• Cognitive status

  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.

Study Arms (1)

CARE-ICU

Critically ill patients during ICU admission

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ICU patients admitted to Parc Taulí Hospital

You may qualify if:

• ≥ 18 years old
• Admitted to the ICU for at least ≥ 24 hours

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (1)

I3PT Instituto de Investigación e Innovación Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Related Publications (1)

• 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. doi: 10.1038/s41598-026-36684-y. Online ahead of print.

  PMID: 41588070 DERIVED

MeSH Terms

Conditions

Critical Illness; Pain

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: September 4, 2025
• Study Start: November 1, 2018
• Primary Completion: September 14, 2024
• Study Completion: September 15, 2024
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

ES (1)