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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02913833
Other study ID # CHUB- EVA-REVA
Secondary ID
Status Completed
Phase N/A
First received September 15, 2016
Last updated January 18, 2018
Start date March 9, 2016
Est. completion date December 12, 2017

Study information

Verified date January 2018
Source Brugmann University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Pain 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.

The 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.


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date December 12, 2017
Est. primary completion date December 12, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Sequential inclusion of all patients hospitalized in the chronic revalidation hospital unit of the CHU Brugmann - Queen Astrid site

Exclusion Criteria:

- Pathological cognitive state (MMS<23/30)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Pain evaluation
Pain will be assessed four times per day on a visual analogic scale.

Locations

Country Name City State
Belgium CHU Brugmann Brussels

Sponsors (1)

Lead Sponsor Collaborator
Brugmann University Hospital

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

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. — View 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. Portuguese. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Pain score (EVA) Pain assessment on the Visual Analogic Scale (EVA) 5 minutes, 4 times per day
Primary Hospitalization duration Hospitalization length (average of 48 days)
Primary HADS score Hospital Anxiety Depression Scale (questionnaire) Baseline (first day of hospitalisation)
Primary HADS score Hospital Anxiety Depression Scale (questionnaire) Day 30 of hospitalisation
Primary Barthel Index Daily life activities assessment Baseline (first day of hospitalisation)
Primary Barthel Index Daily life activities assessment Day 30 of hospitalisation
Primary CACS score Composite score of analgesics consumption Hospitalization length (average of 48 days)
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