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Prognosis of Anxiety in Intensive Care Unit

Prognosis of Anxiety in Intensive Care Unit

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02355626
Acronym
PAN-ICU
Enrollment
391
Registered
2015-02-04
Start date
2014-04-30
Completion date
2017-12-31
Last updated
2018-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety

Keywords

Anxiety, level of anxiety, delirium, agitation, tools for measuring anxiety, neuroendocrine system

Brief summary

Anxiety is commonly considered as an epiphenomenon of the cognitive and emotional response to a threat. Anxiety is a consequence of the reciprocal interaction between stress and the neuroendocrine, autonomic and immune systems. A systematic and circumstantial assessment of anxiety in critically ill patients has never been done. Our hypothesis is that high levels of anxiety at ICU admission are associated with death or the occurrence of one or more organ failure during the first 7 days, and that anxiety should be considered as a warning sign in critically ill patients.

Detailed description

Multicentre prospective study. Demographic data, diagnosis, severity scores and vital signs will be assessed at admission. Within the first 12 hours, and at day 4 and day 7, anxiety will be assessed by the STAI scale, Geriatric Anxiety Inventory (GAI) scale, and a specific questionnaire assessing anxiety in the intensive care (REAX). Visual Analogue Scale (VAS) scoring for anxiety, starvation, thirst, pain and dyspnoea will be collected daily. Anxiety and depression will be evaluated by the Hospital Anxiety and Depression Scale (HADS) on day 7. Patients will be assessed by psychologists or trained doctors, the team in charge of the patient will not be aware of the result of this evaluation. Clinical and biological data regarding the hemodynamic, neurological, respiratory and renal status will be collected from admission to day 7, as well as parameters required for computing the Sequential Organ Failure Assessment (SOFA) score.

Interventions

None listed

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All adult patients admitted to the ICU * Patient without delirium at admission (assessed using the CAM-ICU score)

Exclusion criteria

* Severe hearing impairment or poor understanding of French language * History of serious psychiatric illness * Comatose or sedated patient at admission * Diagnosis of voluntary self-poisoning, or polytrauma at admission

Design outcomes

Primary

MeasureTime frame
Occurrence of death or organ failure.7 days

Secondary

MeasureTime frame
Severity of an ongoing organ failure (maximum SOFA score)7 days
Assessment of anxiety according to State Trait Anxiety Inventory score (STAI)7 days
1-Occurrence of shock, delirium, or stress-related complications (upper gastrointestinal bleeding, acute coronary syndrome)7 days
Assessment of anxiety according to the Visual Analog Scale (VAS)7 days
Assessment of Geriatric Anxiety Inventory score (GAI)7 days
Assessment of anxiety according to REAX score7 days

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026