跳至主要内容
临床试验/NCT05925907
NCT05925907招募中不适用

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

Erasmus Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年12月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Validation of a Dutch language translation of standard cold intolerance form

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Traumatic hand injury
  • Sufficient knowledge of the Dutch language (at least level B1)

排除标准

  • - Definitive total hand amputation

结局指标

主要结局

Validation of a Dutch language translation of standard cold intolerance form

时间窗: 1 year

Test and retest of a Dutch language model of the CISS score

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Reinier Feitz, MD PhD

Reinier Feitz, MD, PhD, plastic surgeon

Erasmus Medical Center

研究点 (1)

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