NCT07339891

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
1mo left

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress87%
Jun 2025Jun 2026

Study Start

First participant enrolled

June 23, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 14, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2026

Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

January 5, 2026

Last Update Submit

January 13, 2026

Conditions

Keywords

Post-traumatic stress disorderStay in intensive care

Outcome Measures

Primary Outcomes (2)

  • ICE questionnaire score

    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

    Between 1 and 3 days after discharge from the intensive care unit.

  • Quality of life questionnaire score (SF36)

    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

    Day 30 after discharge from hospital

Eligibility Criteria

Age18 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patient (≥ 18 years) having a stay in intensive care \> 48 hours

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Réanimation Chirurgicale - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2026

First Posted

January 14, 2026

Study Start

June 23, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 23, 2026

Last Updated

January 14, 2026

Record last verified: 2026-01

Locations