Cross-cultural Adaptation of the 'Cold Intolerance Severity Score' (CISS)

Status Recruiting

Clinical Trial Summary

To report Cold intolerance by the CISS score in medicolegal patients.

Clinical Trial Description

Rationale Cold intolerance is an important finding in hand trauma patients, nerve injury, crush injury, degloving injury or amputation. Cold intolerance as a symptom is probably the least responsive to any known medical treatment. 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 ;

Study Design

Related Conditions & MeSH terms

Hand Injuries

Clinical Trial Details

NCT number	NCT05925907
Study type	Observational
Source	Erasmus Medical Center
Contact	Reinier Feitz, MD PhD
Phone	0303200556
Email	info@handcentrum.nl
Status	Recruiting
Phase
Start date	December 12, 2023
Completion date	January 1, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Cross-cultural Adaptation of the 'Cold Intolerance Severity Score' (CISS) to the Dutch Language. — Ciss-DLV

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms