Overview

This trial is active, not recruiting.

Condition critical illness
Sponsor Oslo University Hospital
Start date May 2010
End date October 2016
Trial size 120 participants
Trial identifier NCT02279212, S-07505b (REK)

Summary

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.

1. What type of pain has ICU survivors and how do pain change over time, related to treatment/rehabilitation and the illness' development?

2. What is the relationship between different pain characteristic, quality of life, anxiety, depression, fatigue, sleep and PTSD in these patients?

3. What is these patients largest obstacle for good QoL after discharge from hospital?

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective

Primary Outcomes

Measure
Do pain change over time in ICU survivors meassured with BPI and NPSI?
time frame: 1year after ICU discharge

Secondary Outcomes

Measure
What is the relationship between patients self reported experience of pain and neurophysiological findings?
time frame: 3 months after ICU discharge
What is the relationship between patients self reported experience of pain and neurophysiological findings?
time frame: 1 year after ICU discharge
How are ICU survivors health related quality of life meassured with SF12?
time frame: 3 months after ICU discharge
How are ICU survivors health related quality of life meassured with SF 12?
time frame: 1 year after ICU discharge

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Neuropathic Pain and Quality of Life in ICU Survivors
Principal investigator Audun Stubhaug, MD PhD
Description A prospective and longitudinal survey 3 time points for data collection: 1. ICU - background data about the patients ICU stay (days on ventilator, medication, treatment, SAPS II, SOFA etc). 2. 3 months after ICU discharge - survey about pain, QoL, sleep, fatigue, Post traumatic stress disorder (PTSD), anxiety and depression. 3. 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
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Oslo University Hospital.