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Completed

NCT Number: NCT07153380

Evolution of Physical and Emotional Distress in ICU

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

I3PT Instituto de Investigación e Innovación Parc Taulí

Sabadell, Barcelona, 08208, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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).

  2. 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).

Secondary outcomes

  1. 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.

    MoCA test

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Registry information

Official study title

Critical Assessment of Respiratory, Physical and Emotional Distress in Critically Ill Patients With and Without Invasive Mechanical Ventilation

Acronym: CARE-ICU

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Sep 4, 2025
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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