- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02279212
Neuropathic Pain and Quality of Life in ICU Survivors (NEUPAQ)
Previous research on intensive care unit (ICU) survivors shows that rehabilitation is challenging, because of patients experiences of disease related problems both under and after treatment. Approximately 20 % of patients die within hospital, up to 80% suffer from hallucinations and nightmares, deal with paranoiac experiences, chronic pain and other symptoms and disability (Angus et al 2004; De Letter et al 2001; Ely et al 2001; Nelson et al 2006; Van den Berghe et al 2001; Van den Berghe et al 2003) . A recent study shows that 28% of intensive care survivors have chronic pain that reduce their health related quality of life (Boyle et al 2004).
The aim of this study is to perform a survey about prevalence of pain type, and which consequences this causes when it comes to function and quality of life up to 12 months after the ICU stay.
- What type of pain has ICU survivors and how do pain change over time, related to treatment/rehabilitation and the illness' development?
- What is the relationship between different pain characteristic, quality of life, anxiety, depression, fatigue, sleep and PTSD in these patients?
- What is these patients largest obstacle for good QoL after discharge from hospital?
Studieoversikt
Status
Forhold
Detaljert beskrivelse
A prospective and longitudinal survey 3 time points for data collection:
- ICU - background data about the patients ICU stay (days on ventilator, medication, treatment, SAPS II, SOFA etc).
- 3 months after ICU discharge - survey about pain, QoL, sleep, fatigue, Post traumatic stress disorder (PTSD), anxiety and depression.
- One year after ICU discharge - the same as 3 months.
Survey instruments:
Pain - Brief Pain Inventory, Neuropathic Pain Syndrome Inventory, Pain diary QoL - SF 12, Sleep - General Sleep Disorder Scale Fatigue - Lee Fatigue Scale Anxiety and depression - Hospital Anxiety and Depression Scale PTSD - PTSS 10 Social Provision - Revised Social Provision Scale
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
-
Oslo, Norge, 0424
- Oslo University Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- ICU stay longer than 48 h
- 18 years old or older
- Patients must write and understand Norwegian well.
Exclusion Criteria:
- Dying patients
- No acceptance form next of kind
- No concent from the patients
- Other that the researcher thinks should be excluded f. ex Patients with very bad prognosis
- Patients with low probability for self report after ICU stay
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Do pain change over time in ICU survivors meassured with BPI and NPSI?
Tidsramme: 1year after ICU discharge
|
We will compare the results from 3 months with 1 year and look for differences.
|
1year after ICU discharge
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
What is the relationship between patients self reported experience of pain and neurophysiological findings?
Tidsramme: 3 months after ICU discharge
|
3 months after ICU discharge
|
What is the relationship between patients self reported experience of pain and neurophysiological findings?
Tidsramme: 1 year after ICU discharge
|
1 year after ICU discharge
|
How are ICU survivors health related quality of life meassured with SF12?
Tidsramme: 3 months after ICU discharge
|
3 months after ICU discharge
|
How are ICU survivors health related quality of life meassured with SF 12?
Tidsramme: 1 year after ICU discharge
|
1 year after ICU discharge
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Audun Stubhaug, MD PhD, Oslo University Hospital
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
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
- S-07505b (REK)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Kritisk sykdom
-
Unity Health TorontoUkjentUtdanning, medisinsk | Critical Care UltrasonographyCanada
-
Unity Health TorontoFullført
-
Nanjing PLA General HospitalFullførtCritical Care Pasient; Nedre fordøyelseskanal lidelse; | Tykktarmslesjoner;
-
Heidelberg UniversityUkjentSedering av cerebrovaskulær ventilerte Critical Care-pasienterTyskland
-
National Taiwan University Clinical Trial CenterRekrutteringKardiologi, Critical Care Medicine, Emergency Medical ServiceTaiwan