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Diary for Severe Trauma

Impact of an Intensive Care Unit Diary on Long-term Quality of Life After Severe Trauma

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02305303
Acronym
Qualitrau
Enrollment
226
Registered
2014-12-02
Start date
2014-11-09
Completion date
2017-11-08
Last updated
2021-10-26

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

Conditions

Post-traumatic Stress Disorder

Keywords

Quality of life, post-traumatic stress disorder, trauma

Brief summary

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.

Detailed 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.

Interventions

PROCEDUREDiary

A diary written prospectively during the ICU stay by the staff and relatives

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

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

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of life12 months after the traumaTo assess the quality of life (QoL), investigator will use the WHO Quality of Life questionnaire Brief Version (WHOQOL- Bref) in its french-language version. exploring four dimensions (physical, psychological, social and environmental).

Secondary

MeasureTime frameDescription
post-traumatic stress disorder (PTSD)12 months after the traumaTo assess the frequency and the intensity of PTSD, investigator will use the Impact of Events Scale-revised questionnaire (IES-R), a valid and reliable 22-item screening tool that assesses symptoms of intrusion, avoid-ance, and hyperarousal
predictive factors of decrease in QoL after severe trauma12 months after the traumaAt the admission, investigator will notice trauma data. Plus, the investigator will ask the conscious patient or his/her next of kin about sociodemographic, professional characteristics at the admission and 12 months after the trauma
patients' expectations12 months after the traumaConduction of a quality study through a semi-open questionary about the care during and after the intensive care unit stay and about the diary (experimental group only)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026