Diary for Severe Trauma (Qualitrau)
Impact of an Intensive Care Unit Diary on Long-term Quality of Life After Severe Trauma
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Paris, France, 75013
- Département d'Anesthésie-Réanimation Groupe Hospitalier Pitié Salpêtrière
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Diary
Use of diary
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A diary written prospectively during the ICU stay by the staff and relatives
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Aucune intervention: Without Diary
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Quality of life
Délai: 12 months after the trauma
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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).
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12 months after the trauma
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
post-traumatic stress disorder (PTSD)
Délai: 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
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12 months after the trauma
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predictive factors of decrease in QoL after severe trauma
Délai: 12 months after the trauma
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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
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12 months after the trauma
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patients' expectations
Délai: 12 months after the trauma
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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)
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12 months after the trauma
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Marie Benazzour, Nurse, Assistance Publique - Hôpitaux de Paris
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- K131202
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