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NCT Number: NCT07339891

Experience of Staying in Intensive Care and Impact on Quality of Life

It now seems well established that post-traumatic stress disorder following a stay in intensive care is one of the factors that affects patients' quality of life after they leave hospital.

Several qualitative and quantitative studies suggest that there are several factors associated with the onset of this post-traumatic stress disorder, including the absence of memory of the stay in intensive care. With this in mind, some intensive care units (in France and abroad) are implementing measures to improve the patient experience during their stay, particularly to compensate for this lack of memory: several studies show a link between the introduction of intensive care unit logbooks and a decrease in the incidence of post-traumatic stress disorder after returning home.

The aim of this research project is to measure the experience of the stay in intensive care and its possible impact on quality of life. It is therefore part of a process of implementing measures within general and cardiovascular surgical intensive care units, aimed at better assessing and improving the quality of life of patients after a stay in intensive care.

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Key information

Conditions

Post-traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Réanimation Chirurgicale - CHU de Strasbourg - France

Strasbourg, 67091, France

Location status: Recruiting

Location contact

Coralie PAUZET, MD

CONTACT

[email protected]

33 3 69 55 05 57

Coralie Pauzet, MD

PRINCIPAL_INVESTIGATOR

Julien GODET, Statistician

SUB_INVESTIGATOR

Margot TRIBOULET, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Adult patient (≥ 18 years)
Stay in intensive care > 48 hours

Exclusion criteria

Admission to intensive care following scheduled surgery.
Readmission to intensive care (previous admission within the 30 days prior).
Patient under legal guardianship
Inability to complete a questionnaire
Poor reading and/or speaking comprehension of French
Patient under guardianship or conservatorship.

Treatment and study plan

Primary outcomes

ICE questionnaire score

Time frame: Between 1 and 3 days after discharge from the intensive care unit.
ICE (Impact Confidence Experience) questionnaire score:

The scores for each letter (I, C, E) are added together or averaged.

The higher the score, the better. This indicates a positive experience, trust, and a significant impact.

Simple example:
- Impact = 8/10 → The service was very helpful.
- Trust = 9/10 → I trust this team.
- Experience = 7/10 → My experience was quite good.
Average ICE score = (8 + 9 + 7) ÷ 3 = 8/10
Quality of life questionnaire score (SF36)

Time frame: Day 30 after discharge from hospital
The SF-36 is a health questionnaire consisting of 36 questions.

Each dimension receives a score from 0 to 100:
- 100 = very good quality of life
- 0 = very poor quality of life

Study contacts

Contact information is provided by the study sponsor or research team.

Coralie PAUZET, MD

CONTACT

[email protected]

33 3 69 55 05 57

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: Expe-Rea

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jan 14, 2026
Registry last updated: Jan 14, 2026

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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Recruiting