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NCT05615181 Clinical Trial

Evaluation of the French Translation of Gothenburg Trismus Questionnaire (GTQ)

Trismus Clinical Trial

— TRISMUS  

Official title:
Evaluation of the French Translation of Gothenburg Trismus Questionnaire (GTQ)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05615181
Other study ID # 00009
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 22, 2020
Est. completion date December 31, 2022

Study information
Verified date August 2023
Source Centre Hospitalier de Valence
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A monocentric Study to evaluate the french translation of Gothenburg Trismus Questionnaire (GTQ).

Description:

Trismus is defined as a limitation in the mouth/jaw-opening ability due to a reduced mandible mobility. Trismus can occur from benign jaw related conditions, often referred to as temporomandibular disorders (TMD). It can also result from local or metastatic tumor growth of head and neck (H&N) tumors, and more importantly, as a debilitating side-effect to H&N oncology treatment, especially radiotherapy The Gothenburg Trismus Questionnaire (GTQ) is a Patient Reported Outcome, validated in English, portuguese and sweden language. The aim of this study is to develop a new tool in french language and to evaluate the specific impact of trismus on quality of life .

Recruitment information / eligibility
Status Completed
Enrollment 310
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility - Inclusion Criteria: - Patient treated for trismus - Age = 18 years old - Read, write and understand the French language - Exclusion Criteria: - Patient under guardianship, deprived of liberty, safeguard of justice - Refusal to participate in research

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Ch Valence Valence Drome

Sponsors (2)
Lead Sponsor Collaborator
Centre Hospitalier de Valence Göteborg University

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Gothenburg Trismus Questionnaire (GTQ) patient Reported Outcome measure: score 0-4 (0 means a better outcome, 4 means a worse outcome.) once at inclusion
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