Evolution of Physical and Emotional Distress in ICU

NCT ID: NCT07153380

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 62 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2024-09-15

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

CARE-ICU

Critically ill patients during ICU admission

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Corporacion Parc Tauli

OTHER

Sponsor Role: lead

Responsible Party

Elisabet Doña-López

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

I3PT Instituto de Investigación e Innovación Parc Taulí

Sabadell, Barcelona, Spain

Countries

Spain

Other Identifiers

2025/5057

Identifier Type: -

Identifier Source: org_study_id