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NCT Number: NCT02279212

Neuropathic Pain and Quality of Life in ICU Survivors

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?

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Key information

Conditions

Critical Illness Disease Attributes Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo University Hospital

Oslo, 0424, Norway

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Do pain change over time in ICU survivors meassured with BPI and NPSI?

    Time frame: 1year after ICU discharge

    We will compare the results from 3 months with 1 year and look for differences.

Secondary outcomes

  1. What is the relationship between patients self reported experience of pain and neurophysiological findings?

    Time frame: 3 months after ICU discharge

  2. What is the relationship between patients self reported experience of pain and neurophysiological findings?

    Time frame: 1 year after ICU discharge

  3. How are ICU survivors health related quality of life meassured with SF12?

    Time frame: 3 months after ICU discharge

  4. How are ICU survivors health related quality of life meassured with SF 12?

    Time frame: 1 year after ICU discharge

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Acronym: NEUPAQ

Important dates

Study start
2010
Primary completion
2018
Study completion
2018
First posted
Oct 31, 2014
Registry last updated
Mar 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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