Cross-cultural Adaptation of the 'Cold Intolerance Severity Score' (CISS) to the Dutch Language.
NCT ID: NCT05925907
Last Updated: 2023-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2023-12-12
2025-01-01
Brief Summary
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Detailed Description
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Perhaps due to the fact that we have no control over it, the consequences for cold tolerance are seldom researched. patients involved in medicolegal claims report more pain and less function than controls. Medicolegal examinations for various indications offer a long-term outcome view for the symptoms of cold tolerance. Therefore, together with Handcentrum we want to translate, improve and test the current PROM for cold intolerance CISS
Objective To report Coldintolerance by the CISS score in medicolegal patients.
Study parameters / Endpoints A validated Dutch version of the CISS A report on 100 CISS scores in medicolegal patients Examine if a shorter version of the CISS questionnaire is feasible
Study design 2-3 independent forward translations (e.g. from English into Dutch) by native speakers of the target language (e.g. Dutch). One of the translators understands the concept, one translator has no knowledge of the concept that the questionnaire measures and no medical background.
The translators make a joint forward translation together with an independent person.
2-3 independent back-translations (e.g. from Dutch into English) by native speakers of the source language (e.g. English). Both translators have no knowledge of the concept the questionnaire measures and have no medical background. ... Read more
Burden and risk These questionnaires are mandatory anyway. So, no additional time for the patients needed. There is no risk involved. There is no alteration in the medical or clinical pathway.
Recruitment and consent automatically enrolment and permission via Medisoft software from HandC
Summary Translation and validation of a Dutch version of a PROM for cold intolerance
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Handsurgery patients
patients recruited from trauma handsurgery outpatient clinic in an academic teaching hospital, level 1 trauma unit.
No interventions assigned to this group
Medicolegal patients
Medicolegal patients that are examined in order to asses their personal injury claim.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Traumatic hand injury
* Sufficient knowledge of the Dutch language (at least level B1)
Exclusion Criteria
ALL
No
Sponsors
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Handcentrum, Bilthoven, The Netherlands
UNKNOWN
Erasmus Medical Center
OTHER
Responsible Party
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Reinier Feitz, MD PhD
Reinier Feitz, MD, PhD, plastic surgeon
Principal Investigators
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Reinier Feitz, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Locations
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Erasmuc MC
Rotterdam, South Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Reinier Feitz, MD PhD
Role: primary
Other Identifiers
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PANAMA-10267
Identifier Type: -
Identifier Source: org_study_id