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Neuropathic Pain and Quality of Life in ICU Survivors (NEUPAQ)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02279212
Recruitment Status : Completed
First Posted : October 31, 2014
Last Update Posted : March 4, 2020
Sponsor:
Information provided by (Responsible Party):
Anne Kathrine Langerud, Oslo University Hospital

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?

Condition or disease
Critical Illness

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

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Study Type : Observational
Actual Enrollment : 127 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Neuropathic Pain and Quality of Life in ICU Survivors
Study Start Date : May 2010
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : September 6, 2018



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients in a Norwegian ICU. Medical and surgical patients, no thorasic surgery or trauma.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279212


Locations
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Norway
Oslo University Hospital
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
Investigators
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Principal Investigator: Audun Stubhaug, MD PhD Oslo University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anne Kathrine Langerud, MNSc, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02279212    
Other Study ID Numbers: S-07505b (REK)
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: March 2020
Keywords provided by Anne Kathrine Langerud, Oslo University Hospital:
Critical illness
pain
quality of life
Additional relevant MeSH terms:
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Neuralgia
Critical Illness
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Disease Attributes
Pathologic Processes