Ignite Creation Date:
2025-12-26 @ 10:18 PM
Ignite Modification Date:
2026-01-03 @ 4:38 AM
Study NCT ID:
NCT02279212
Status:
COMPLETED
Last Update Posted:
2020-03-04
First Post:
2010-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuropathic Pain and Quality of Life in ICU Survivors
Sponsor:
Oslo University Hospital
Organization:
Study Overview
Official Title:
Neuropathic Pain and Quality of Life in ICU Survivors
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NEUPAQ
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?
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: