Clinical trial NCT02279212: Neuropathic Pain and Quality of Life in ICU Survivors
Official title: Neuropathic Pain and Quality of Life in ICU Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Keywords: Critical illness
pain
quality of life
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2014-10-31
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients in a Norwegian ICU. Medical and surgical patients, no thorasic surgery or trauma.

Brief 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?

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Do pain change over time in ICU survivors meassured with BPI and NPSI?
timeFrame: 1year after ICU discharge
Secondary outcomes:
measure: What is the relationship between patients self reported experience of pain and neurophysiological findings?
timeFrame: 3 months after ICU discharge
measure: What is the relationship between patients self reported experience of pain and neurophysiological findings?
timeFrame: 1 year after ICU discharge
measure: How are ICU survivors health related quality of life meassured with SF12?
timeFrame: 3 months after ICU discharge
measure: How are ICU survivors health related quality of life meassured with SF 12?
timeFrame: 1 year after ICU discharge
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Audun Stubhaug, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Langerud AK, Rustoen T, Smastuen MC, Kongsgaard U, Stubhaug A. Intensive care survivor-reported symptoms: a longitudinal study of survivors' symptoms. Nurs Crit Care. 2018 Jan;23(1):48-54. doi: 10.1111/nicc.12330. Epub 2017 Dec 15.