Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05925907
Status:
RECRUITING
Last Update Posted:
2023-12-21
First Post:
2023-06-13
Brief Title:
Cross-cultural Adaptation of the Cold Intolerance Severity Score CISS to the Dutch Language
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
Ciss-DLV-Cross-cultural Adaptation of the Cold Intolerance Severity Score CISS to the Dutch Language
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Ciss-DLV
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 eg from English into Dutch by native speakers of the target language eg 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 eg from Dutch into English by native speakers of the source language eg 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
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 eg from English into Dutch by native speakers of the target language eg 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 eg from Dutch into English by native speakers of the source language eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None