Trials / Withdrawn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- Withdrawn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
| Type | Name | Description |
|---|---|---|
| OTHER | COMQ-12 questionnaire | Subjects 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.