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Completed

NCT Number: NCT02305303

Diary for Severe Trauma

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Département d'Anesthésie-Réanimation Groupe Hospitalier Pitié Salpêtrière

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Diary

Procedure

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

Primary outcomes

  1. Quality of life

    Time frame: 12 months after the trauma

    To 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 outcomes

  1. post-traumatic stress disorder (PTSD)

    Time frame: 12 months after the trauma

    To 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

  2. predictive factors of decrease in QoL after severe trauma

    Time frame: 12 months after the trauma

    At 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

  3. patients' expectations

    Time frame: 12 months after the trauma

    Conduction 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)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: Qualitrau

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 2, 2014
Registry last updated
Oct 26, 2021

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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