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Trials / Withdrawn

WithdrawnNCT04423952

Validity of the French Version of the Quality of Life Questionnaire COMQ12-FR

Status
Withdrawn
Phase
Study type
Observational
Enrollment
0 (actual)
Sponsor
Assistance Publique - Hôpitaux de Paris · Academic / Other
Sex
All
Age
7 Years – 15 Years
Healthy volunteers
Not accepted

Summary

The World Health Organization estimates that chronic otitis media could reach between 65 and 350 million people worldwide and thus be an important cause of medical consultation and prescription drugs. The medical care of chronic otitis is difficult, despite several medical and surgical treatment options. Moreover this pathology is gladly recurrent. The completion of a standardized questionnaire to track symptoms objectively over time is fundamental to verify the efficacy of specific treatments and to compare treatments. The quality of life measurement questionnaire related to chronic otitis media (COMQ-12) is a new questionnaire, validated in English, to assist the physician in evaluating chronic otitis media. The objective of this study is to translate and validate the test in French in children.

Detailed description

The World Health Organization estimates that chronic otitis media could reach between 65 and 350 million people worldwide and thus be an important cause of medical consultation and prescription drugs. The medical care of chronic otitis is difficult, despite several medical and surgical treatment options. Moreover this pathology is often recurrent. The completion of a standardized questionnaire to track symptoms objectively over time is fundamental to verify the efficacy of specific treatments and to compare treatments. The quality of life measurement questionnaire related to chronic otitis media (COMQ-12) is a new questionnaire, validated in English, to assist the physician in evaluating chronic otitis media. The original version of the COMQ12 questionnaire, in English, was developed by Phillips et al.. The construction of this questionnaire was based on three other questionnaires : the Chronic Ear Survey (CES), the Chronic Otitis Media Outcome-15 (COMOT-15), and the Chronic Otitis Media-5 (COM-5). The initial validation of the English version of Phillips et al. was evaluated with an alpha value of Cronbach to 0.889, which shows high internal consistency and would allow its use in several reputed international centers of otology. The objective of this study is to translate and validate the test in French in children.

Conditions

Interventions

TypeNameDescription
OTHERCOMQ-12 questionnaireSubjects respond to COMQ-12 questionnaire twice at 15 days apart. COMQ-12 : quality of life measurement questionnaire related to chronic otitis media.

Timeline

Start date
2020-05-20
Primary completion
2020-05-20
Completion
2020-05-20
First posted
2020-06-09
Last updated
2025-09-25

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04423952. Inclusion in this directory is not an endorsement.