NCT03581253

Validation of a French-language Version of Quality of Life Questionnaires in Patients With Peripheral Facial Palsy

Validation of a French-language Version of Specific Quality of Life Questionnaires in Patients With Peripheral Facial Palsy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Assistance Publique Hopitaux De Marseille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Facial palsy is a serious and disabling disease whose drudgery and sensation are probably underestimated. Psychological, social and economic issues have major impacts although vital prognosis is not engaged in this pathology. Facial palsy remains a personal drama for patient. Consequences may take the form of: aesthetic deformation, modification of body image, with socio-professional consequences. Beside unsightly facial aspects, weakness of facial muscles can cause troubles in eating, drinking, talking, communicating personal emotions and communication. Facial palsy impacts patients' quality of life (QOL) and affects mental health. This wide multidimensional concept usually includes self-measures of physical and mental health. QOL is evaluated with general and specific scales. General scales allow to compare QOL of different diseases, when specific scales focus on one disease and consider all aspects related to this disease and therefore are more appropriate and sensitive in dimensions related to patient disease and health. "Facial disability Index" (FDi) and "Facial Clinimetric Evaluation" (FaCE) are the most used validated questionnaires to assess QOL of patients suffering from peripheral facial palsy (PFP). There is no existing validated questionnaire or scale in French version despite many French studies on PFP available. Using these questionnaires in French language requires translation and strict approval of the new language version. The aim of the study is to translate and validate French versions of specific scales of QOL in peripheral facial palsy patients: FDI and FaCE. Secondary objective is to evaluate QOL of patients depending on PFP etiology. Translation process will be done respecting internationally recognized rules. A pilot study will be performed on 5 physicians and 5 patients in order to validate the questionnaires translations. French versions obtained will be used for their validation on 80 patients suffering from PFP. Cronbach's alpha will be estimated to check internal consistency of FDI and FaCE scales. Test re-test reliability will be calculated with inter-class correlation, reiterating questionnaires one week later. Scores of FDI and FaCE scales will be compared to other clinical evaluation scales, estimating correlation coefficient. Social function of FDI and FaCE scales will be compared with general scale SF-36 scores, estimating a correlation coefficient.

Detailed description

Facial palsy is a serious and disabling disease whose drudgery and sensation are probably underestimated. Psychological, social and economic issues have major impacts although vital prognosis is not engaged in this pathology. Facial palsy remains a personal drama for patient. Consequences may take the form of: aesthetic deformation, modification of body image, with socio-professional consequences. Beside unsightly facial aspects, weakness of facial muscles can cause troubles in eating, drinking, talking, and communicating personal emotions. Physical as well as psychological repercussions limit daily verbal and non-verbal communication. Facial palsy impacts patients' quality of life (QOL) and affects mental health. Consequently, QOL impacts and directs the patient's care and the healthcare professionals widely take account of QOL. This wide multidimensional concept usually includes self-measures of physical and mental health. QOL is evaluated with general and specific scales. General scales allow to compare QOL of different diseases, when specific scales focus on one disease and consider all aspects related to this disease and therefore are more appropriate and sensitive in dimensions related to patient disease and health. "Facial disability Index" (FDi) and "Facial Clinimetric Evaluation" (FaCE) are the two most used validated questionnaires to assess QOL of patients suffering from peripheral facial palsy (PFP). There is no existing validated questionnaire or scale in French version evaluating QOL of patients with PFP despite many French studies on PFP available. Using these questionnaires in French language requires translation and strict approval of the new language version. The aim of the study is to translate and validate French versions of specific scales of QOL in peripheral facial palsy patients: FDI and FaCE. Secondary objective is to evaluate QOL of patients depending on PFP etiology. Translation process will be done respecting internationally recognized rules. A pilot study will be performed on 5 physicians and 5 patients in order to validate the questionnaires translations. French versions obtained for these 2 questionnaires will be used for their validation on 80 patients suffering from PFP in our hospital. Cronbach's alpha will be estimated to check internal consistency of FDI and FaCE scales. Test re-test reliability will be calculated with inter-class correlation, reiterating questionnaires one week later. Scores of FDI and FaCE scales will be compared to House-Brackmann and Sunnybrook clinical evaluation scales, estimating correlation coefficient. Social function of FDI and FaCE scales will also be compared with general scale SF-36 scores, estimating a correlation coefficient.

Conditions

• Peripheral Facial Paralysis
• Quality of Life

Interventions

Type	Name	Description
OTHER	Facial disability Index" (FDi)	questionnaires regarding to quality of life
OTHER	"Facial Clinimetric Evaluation" (FaCE)	questionnaires regarding to quality of life

Timeline

• Start date: 2017-12-15
• Primary completion: 2018-12-15
• Completion: 2019-06-01
• First posted: 2018-07-10
• Last updated: 2018-07-12

Locations

1 site across 1 country: France