Diary for Severe Trauma (Qualitrau)
Impact of an Intensive Care Unit Diary on Long-term Quality of Life After Severe Trauma
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Paris, Frankrijk, 75013
- Département d'Anesthésie-Réanimation Groupe Hospitalier Pitié Salpêtrière
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Geen tussenkomst: Without Diary
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Quality of life
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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post-traumatic stress disorder (PTSD)
Tijdsspanne: 12 months after the trauma
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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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Marie Benazzour, Nurse, Assistance Publique - Hôpitaux de Paris
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- K131202
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