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

Recruiting

• Conditions: Hand Injuries

• Registration Number: NCT05925907
• Lead Sponsor: Erasmus Medical Center

Brief Summary

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

Detailed 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 Timeline

• Study First Submitted: 2023-06-13
• Study First Submitted QC: 2023-06-22
• Study First Posted: 2023-06-29
• Status Verified: 2023-12
• Study Start: 2023-12-12
• Last Update Submitted: 2023-12-18
• Last Update Posted: 2023-12-21
• Primary Completion: 2024-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• • Definitive total hand amputation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validation of a Dutch language translation of standard cold intolerance form	1 year	Test and retest of a Dutch language model of the CISS score

Trial Locations

Locations (1)

Erasmuc MC; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands