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

December 18, 2023 updated by: Reinier Feitz, MD PhD, Erasmus Medical Center

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

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

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Netherlands, 3015 GD
        • Recruiting
        • Erasmuc Mc
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Handsurgery patients and medicolegal patients

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • - Definitive total hand amputation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Handsurgery patients
patients recruited from trauma handsurgery outpatient clinic in an academic teaching hospital, level 1 trauma unit.
Medicolegal patients
Medicolegal patients that are examined in order to asses their personal injury claim.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of a Dutch language translation of standard cold intolerance form
Time Frame: 1 year
Test and retest of a Dutch language model of the CISS score
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Collaborators

Handcentrum, Bilthoven, The Netherlands

Investigators

  • Principal Investigator: Reinier Feitz, MD PhD, Erasmus Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2023

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

June 13, 2023

First Submitted That Met QC Criteria

June 22, 2023

First Posted (Actual)

June 29, 2023

Study Record Updates

Last Update Posted (Estimated)

December 21, 2023

Last Update Submitted That Met QC Criteria

December 18, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PANAMA-10267

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe