PainNCT02913833
The Impact of Pain Assessment on the Hospital Length of Stay of Patients in a Rehabilitation Unit
A study testing Pain evaluation in people with Pain, run by Brugmann University Hospital at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Pain evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteBelgium
- Study dates
- 9 Mar 2016to 12 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sequential inclusion of all patients hospitalized in the chronic revalidation hospital unit of the CHU Brugmann - Queen Astrid site
Who cannot join
- Pathological cognitive state (MMS<23/30)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Pain
- Being tested
- Pain evaluation
- Keywords
- Pain, Hospital length of stay, Revalidation unit
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain evaluationOther
Pain will be assessed four times per day on a visual analogic scale.
| Study group | Role | What they receive |
|---|---|---|
| Daily pain evaluation | Experimental | Patients recruited in a sequential order within the chronic revalidation unit of the CHU Brugmann hospital, Queen Astrid site. Receives: Other: Pain evaluation |
| Control | No intervention | Patients recruited in a sequential order within the chronic revalidation unit of the CHU Brugmann hospital, Queen Astrid site. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score (EVA)
Pain assessment on the Visual Analogic Scale (EVA)
Measured: 5 minutes, 4 times per day
Hospitalization duration
Measured: Hospitalization length (average of 48 days)
HADS score
Hospital Anxiety Depression Scale (questionnaire)
Measured: Baseline (first day of hospitalisation)
HADS score
Hospital Anxiety Depression Scale (questionnaire)
Measured: Day 30 of hospitalisation
Barthel Index
Daily life activities assessment
Measured: Baseline (first day of hospitalisation)
Barthel Index
Daily life activities assessment
Measured: Day 30 of hospitalisation
CACS score
Composite score of analgesics consumption
Measured: Hospitalization length (average of 48 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study start9 Mar 2016
- Primary completion12 Dec 2017
- Study completion12 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Hatem, Brugmann University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02913833
- Sponsor's protocol ID
- CHUB- EVA-REVA
- Status last verified
- Jan 2018
- First submitted
- 15 Sep 2016
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25739508Kreling 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.
PubMed 17340726Schoenthaler 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.
PubMed 25010299
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Pain Assessment on the Hospital Length of Stay of Patients in a Rehabilitation Unit
- ClinicalTrials.gov ID
- NCT02913833
- Acronym / sponsor ID
- CHUB- EVA-REVA
- Conditions
- Pain
- Keywords
- Pain, Hospital length of stay, Revalidation unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 9 Mar 2016 (actual)
- Primary completion
- 12 Dec 2017 (actual)
- Study completion
- 12 Dec 2017 (actual)
- First posted
- 26 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daily pain evaluation | Experimental | Other: Pain evaluationPatients recruited in a sequential order within the chronic revalidation unit of the CHU Brugmann hospital, Queen Astrid site. |
| Control | No intervention | –Patients recruited in a sequential order within the chronic revalidation unit of the CHU Brugmann hospital, Queen Astrid site. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Sequential inclusion of all patients hospitalized in the chronic revalidation hospital unit of the CHU Brugmann - Queen Astrid site
Key exclusion criteria (1 listed)
- Pathological cognitive state (MMS<23/30)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain evaluationPain will be assessed four times per day on a visual analogic scale. | Other | Daily pain evaluation |
Primary outcome
Pain score (EVA)
Time frame: 5 minutes, 4 times per day
Pain assessment on the Visual Analogic Scale (EVA)
Hospitalization duration
Time frame: Hospitalization length (average of 48 days)
HADS score
Time frame: Baseline (first day of hospitalisation)
Hospital Anxiety Depression Scale (questionnaire)
HADS score
Time frame: Day 30 of hospitalisation
Hospital Anxiety Depression Scale (questionnaire)
Barthel Index
Time frame: Baseline (first day of hospitalisation)
Daily life activities assessment
Barthel Index
Time frame: Day 30 of hospitalisation
Daily life activities assessment
CACS score
Time frame: Hospitalization length (average of 48 days)
Composite score of analgesics consumption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Background: PubMed 25739508Aprile 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.
- Background: PubMed 17340726Kreling 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.
- Background: PubMed 25010299Schoenthaler 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain evaluation in people with Pain, run by Brugmann University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (EVA) (time frame: 5 minutes, 4 times per day). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02913833, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.