ClinicalTrials.Veeva

Menu

Diary for Severe Trauma (Qualitrau)

A

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Post-traumatic Stress Disorder

Treatments

Procedure: Diary

Study type

Interventional

Funder types

Other

Identifiers

NCT02305303
K131202

Details and patient eligibility

About

Treatment of severe trauma patients includes intensive cares. Both trauma and intensive care may lead to a post-traumatic stress disorder‬ and then to a decreased quality of life. Diaries may improve the frequency and the intensity of PTSD. Aim of investigator is to assess if diaries may improve quality of life after a severe trauma.

Full description

Trauma is the third cause of death in France and the first cause of death of people under 40 years (48 000 deaths a year).

Severe trauma defined by an Injury Severity Score ( ISS) > 15 implies intensive care.

Intensive care unit admission induces considerable psychological distress and memory troubles, both promoting posttraumatic stress disorder (PTSD) and symptoms of anxiety and depression. A diary written prospectively during the ICU stay by the staff and relatives has been suggested as a means of help¬ing patients to build a more detailed and factual narrative of their ICU stay than would be possible based only on their fragmented memories. Garrouste et al. have shown that the intensive care unit diary significantly affected posttraumatic stress disorders in surviving patients 12 months after intensive care unit discharge.

Besides, severe trauma by itself may decrease the quality of life (QoL). It is recommended to assess QoL on one year after the trauma. In trauma patients, the change in QoL is associated with the presence of a PTSD.

Consequently, severe trauma patients who undergo a double stress, that of the accident and that of the intensive care unit stay: they may so even more have a decrease of their QoL by developing a PSTD.

The investigator formulate the hypothesis that a diary, written by the staff and relatives from the very acute phase of the ICU stay (first 48 hours) to the discharge of ICU would improve the QoL and would decrease the frequency and the intensity of PTSD of the severe trauma patients one year after the trauma.

Enrollment

226 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • all patients over 18
  • with severe trauma (Injury Severity Score (ISS) > 15)
  • admitted in our trauma centered and hospitalized in intensive care unit for more than 48 h

Exclusion criteria

  • non-French language fluent patients
  • Patients with dementia
  • Hospitalization in intensive care unit less than
  • opposition to data utilization

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

226 participants in 2 patient groups

Diary
Experimental group
Description:
Use of diary
Treatment:
Procedure: Diary
Without Diary
No Intervention group

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems