Diary for Severe Trauma (Qualitrau)
Impact of an Intensive Care Unit Diary on Long-term Quality of Life After Severe Trauma
Studieoversikt
Detaljert beskrivelse
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
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Paris, Frankrike, 75013
- Département d'Anesthésie-Réanimation Groupe Hospitalier Pitié Salpêtrière
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Ingen inngripen: Without Diary
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Quality of life
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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post-traumatic stress disorder (PTSD)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Marie Benazzour, Nurse, Assistance Publique - Hôpitaux de Paris
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- K131202
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