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

August 28, 2023 updated by: Centre Hospitalier de Valence
A monocentric Study to evaluate the french translation of Gothenburg Trismus Questionnaire (GTQ).

Study Overview

Status

Completed

Conditions

Detailed 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 .

Study Type

Observational

Enrollment (Actual)

310

Contacts and Locations

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

Study Locations

  • France
    • Drome
      • Valence, Drome, France, 26953
        • Ch Valence

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient treated for trismus

Description

  • 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 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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Centre Hospitalier de Valence

Collaborators

Göteborg University

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 22, 2020

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

November 7, 2022

First Submitted That Met QC Criteria

November 11, 2022

First Posted (Actual)

November 14, 2022

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 28, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00009

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.

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