Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-02-27 @ 1:02 PM
Study NCT ID:
NCT02913833
Status:
COMPLETED
Last Update Posted:
2018-01-23
First Post:
2016-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Pain Assessment on the Hospital Length of Stay of Patients in a Rehabilitation Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-18', 'studyFirstSubmitDate': '2016-09-15', 'studyFirstSubmitQcDate': '2016-09-22', 'lastUpdatePostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain score (EVA)', 'timeFrame': '5 minutes, 4 times per day', 'description': 'Pain assessment on the Visual Analogic Scale (EVA)'}, {'measure': 'Hospitalization duration', 'timeFrame': 'Hospitalization length (average of 48 days)'}, {'measure': 'HADS score', 'timeFrame': 'Baseline (first day of hospitalisation)', 'description': 'Hospital Anxiety Depression Scale (questionnaire)'}, {'measure': 'HADS score', 'timeFrame': 'Day 30 of hospitalisation', 'description': 'Hospital Anxiety Depression Scale (questionnaire)'}, {'measure': 'Barthel Index', 'timeFrame': 'Baseline (first day of hospitalisation)', 'description': 'Daily life activities assessment'}, {'measure': 'Barthel Index', 'timeFrame': 'Day 30 of hospitalisation', 'description': 'Daily life activities assessment'}, {'measure': 'CACS score', 'timeFrame': 'Hospitalization length (average of 48 days)', 'description': 'Composite score of analgesics consumption'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pain', 'Hospital length of stay', 'Revalidation unit'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '25739508', 'type': 'BACKGROUND', 'citation': 'Aprile I, Briani C, Pazzaglia C, Cecchi F, Negrini S, Padua L; Don Carlo Gnocchi Pain-Rehab Group. Pain in stroke patients: characteristics and impact on the rehabilitation treatment. A multicenter cross-sectional study. Eur J Phys Rehabil Med. 2015 Dec;51(6):725-36. Epub 2015 Feb 26.'}, {'pmid': '17340726', 'type': 'BACKGROUND', 'citation': 'Kreling MC, da Cruz DA, Pimenta CA. [Prevalence of chronic pain in adult workers]. Rev Bras Enferm. 2006 Jul-Aug;59(4):509-13. doi: 10.1590/s0034-71672006000400007. Portuguese.'}, {'pmid': '25010299', 'type': 'BACKGROUND', 'citation': 'Schoenthaler M, Miernik A, Offner K, Karcz WK, Hauschke D, Sevcenco S, Kuehhas FE, Bach C, Buchholz N, Wilhelm K. The cumulative analgesic consumption score (CACS): evaluation of a new score to describe postsurgical analgesic consumption as a surrogate parameter for postoperative pain and invasiveness of surgical procedures. Int Braz J Urol. 2014 May-Jun;40(3):330-6. doi: 10.1590/S1677-5538.IBJU.2014.03.06.'}]}, 'descriptionModule': {'briefSummary': 'The financing of the Belgian hospitals is based on a system taking into account the length of hospitalization of a given patient according to his/her pathology, his/her age and his/her geriatric characteristics. This system encourages all hospital to lower the hospitalization duration to the national average for these criteria. This results in better efficiency in the management of hospitalizations but also means a swifter transfer to structures exempted from this system such as revalidation units, nursing homes and psychiatric units. An assessment of the differences in the medical practice, in terms of quality and outcomes of care, is essential for any reform willing to reduce medical costs.\n\nPain management is part of the quality indicators within hospitals. Pain is defined by the International Association for the Study of Pain as "an unpleasant sensory and emotional experience, associated to present or potential tissue damage, or described in terms of such a damage". Several studies have showed that pain affects the quality of life and impacts the daily activities. Acute or chronic pain can cause adverse symptoms such as sleep disturbance, appetite loss, decreased concentration, mood changes and the disruption of familial, work and social activities. Pain might also slow down revalidation processes. A study performed by Aprile et al showed that pain negatively influenced the rehabilitation program of a quarter of the patients having had a stroke. The functional recovery was slower and the costs were higher.\n\nThe aim of this study is to determine if the systematic evaluation of the pain of a patient hospitalized in a revalidation unit has an impact on his/her length of stay.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sequential inclusion of all patients hospitalized in the chronic revalidation hospital unit of the CHU Brugmann - Queen Astrid site\n\nExclusion Criteria:\n\n* Pathological cognitive state (MMS\\<23/30)'}, 'identificationModule': {'nctId': 'NCT02913833', 'briefTitle': 'The Impact of Pain Assessment on the Hospital Length of Stay of Patients in a Rehabilitation Unit', 'organization': {'class': 'OTHER', 'fullName': 'Brugmann University Hospital'}, 'officialTitle': 'The Impact of Pain Assessment on the Hospital Length of Stay of Patients in a Rehabilitation Unit', 'orgStudyIdInfo': {'id': 'CHUB- EVA-REVA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Daily pain evaluation', 'description': 'Patients recruited in a sequential order within the chronic revalidation unit of the CHU Brugmann hospital, Queen Astrid site.', 'interventionNames': ['Other: Pain evaluation']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patients recruited in a sequential order within the chronic revalidation unit of the CHU Brugmann hospital, Queen Astrid site.'}], 'interventions': [{'name': 'Pain evaluation', 'type': 'OTHER', 'description': 'Pain will be assessed four times per day on a visual analogic scale.', 'armGroupLabels': ['Daily pain evaluation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1020', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'CHU Brugmann', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brugmann University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of clinic', 'investigatorFullName': 'Samar Hatem', 'investigatorAffiliation': 'Brugmann University Hospital'}}}}