Ignite Creation Date:
2025-12-26 @ 10:18 PM
Ignite Modification Date:
2026-02-05 @ 9:51 PM
Study NCT ID:
NCT02279212
Status:
COMPLETED
Last Update Posted:
2020-03-04
First Post:
2010-12-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuropathic Pain and Quality of Life in ICU Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 127}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-03', 'studyFirstSubmitDate': '2010-12-06', 'studyFirstSubmitQcDate': '2014-10-30', 'lastUpdatePostDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Do pain change over time in ICU survivors meassured with BPI and NPSI?', 'timeFrame': '1year after ICU discharge', 'description': 'We will compare the results from 3 months with 1 year and look for differences.'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Critical illness', 'pain', 'quality of life'], 'conditions': ['Critical Illness']}, 'referencesModule': {'references': [{'pmid': '29243344', 'type': 'DERIVED', '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."}]}, 'descriptionModule': {'briefSummary': "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).\n\nThe 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.\n\n1. What type of pain has ICU survivors and how do pain change over time, related to treatment/rehabilitation and the illness' development?\n2. What is the relationship between different pain characteristic, quality of life, anxiety, depression, fatigue, sleep and PTSD in these patients?\n3. What is these patients largest obstacle for good QoL after discharge from hospital?", 'detailedDescription': 'A prospective and longitudinal survey 3 time points for data collection:\n\n1. ICU - background data about the patients ICU stay (days on ventilator, medication, treatment, SAPS II, SOFA etc).\n2. 3 months after ICU discharge - survey about pain, QoL, sleep, fatigue, Post traumatic stress disorder (PTSD), anxiety and depression.\n3. One year after ICU discharge - the same as 3 months.\n\nSurvey instruments:\n\nPain - 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients in a Norwegian ICU. Medical and surgical patients, no thorasic surgery or trauma.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ICU stay longer than 48 h\n* 18 years old or older\n* Patients must write and understand Norwegian well.\n\nExclusion Criteria:\n\n* Dying patients\n* No acceptance form next of kind\n* No concent from the patients\n* Other that the researcher thinks should be excluded f. ex Patients with very bad prognosis\n* Patients with low probability for self report after ICU stay'}, 'identificationModule': {'nctId': 'NCT02279212', 'acronym': 'NEUPAQ', 'briefTitle': 'Neuropathic Pain and Quality of Life in ICU Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Neuropathic Pain and Quality of Life in ICU Survivors', 'orgStudyIdInfo': {'id': 'S-07505b (REK)'}}, 'contactsLocationsModule': {'locations': [{'zip': '0424', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Audun Stubhaug, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MNSc', 'investigatorFullName': 'Anne Kathrine Langerud', 'investigatorAffiliation': 'Oslo University Hospital'}}}}