Clinical trial NCT05925907: Cross-cultural Adaptation of the 'Cold Intolerance Severity Score' (CISS) to the Dutch Language.
Official title: Ciss-DLV-Cross-cultural Adaptation of the 'Cold Intolerance Severity Score' (CISS) to the Dutch Language.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hand Injuries
Keywords: CISS, handsurgery, crush, nerve injury , amputation, coldintolerance
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Handcentrum, Bilthoven, The Netherlands
First posted: 2023-06-29
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Handsurgery patients and medicolegal patients

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* - Definitive total hand amputation

Primary outcomes:
measure: Validation of a Dutch language translation of standard cold intolerance form
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmuc MC
state: Zuid-Holland
Study officials:
affiliation: Erasmus Medical Center
name: Reinier Feitz, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: