Neuropathic Pain and Quality of Life in ICU Survivors

Critical Illness Clinical Trial

— NEUPAQ  

Official title:

Neuropathic Pain and Quality of Life in ICU Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02279212
• Other study ID #: S-07505b (REK)
• Status: Completed
• Start date: May 2010
• Est. completion date: September 6, 2018

Study information

• Verified date: March 2020
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: September 6, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Neuralgia

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Do pain change over time in ICU survivors meassured with BPI and NPSI?	We will compare the results from 3 months with 1 year and look for differences.	1year after ICU discharge
Secondary	What is the relationship between patients self reported experience of pain and neurophysiological findings?		3 months after ICU discharge
Secondary	What is the relationship between patients self reported experience of pain and neurophysiological findings?		1 year after ICU discharge
Secondary	How are ICU survivors health related quality of life meassured with SF12?		3 months after ICU discharge
Secondary	How are ICU survivors health related quality of life meassured with SF 12?		1 year after ICU discharge