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

NCT ID: NCT03581253

Last Updated: 2018-07-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-15
• Study Completion Date: 2019-06-30

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

peripheral facial palsy patients

peripheral facial palsy patients will performed questionnaires of quality of life ("Facial disability Index" (FDi) and "Facial Clinimetric Evaluation" (FaCE)

Group Type: EXPERIMENTAL

Facial disability Index" (FDi)

Intervention Type: OTHER

questionnaires regarding to quality of life

"Facial Clinimetric Evaluation" (FaCE)

Intervention Type: OTHER

questionnaires regarding to quality of life

Interventions

Facial disability Index" (FDi)

questionnaires regarding to quality of life

Intervention Type: OTHER

"Facial Clinimetric Evaluation" (FaCE)

questionnaires regarding to quality of life

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patient with peripheral facial palsy
• Age over 18 years old.
• Subject wishing and able to give informed consent and to respect the requirements of the protocol

Exclusion Criteria

• Patient not being French.
• Patient who can not read French.
• Facial graduation.
• Facial dysfunction other than PFP such as facial trauma.
• Major medical or psychiatric illness that, in the opinion of the investigator, would pose a risk to the subject or could compromise compliance with the study protocol.
• Participation in other studies in the 30 days prior to inclusion in this study.
• Legal incapacity or limited legal capacity.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

EMILIE GARRIDO PRADALIE

Role: STUDY_DIRECTOR

ASSISTANCE PUBLIQUE DES HOPITAUX DE MARSEILLE

Locations

Assistance Publique Des Hopitaux de Marseille

Marseille, PACA, France

Site Status: RECRUITING

Countries

France

Central Contacts

MARION MONTAVA, MD

Role: CONTACT

Marion.MONTAVA@ap-hm.fr

+33491435618

CECILE LAVOUTE, PHD

Role: CONTACT

cecile.lavoute@ap-hm.fr

+33491381878

Facility Contacts

CECILE LAVOUTE, PHD

Role: primary

cecile.lavoute@ap-hm.fr

+33491381878

Other Identifiers

2017-44

Identifier Type: -

Identifier Source: org_study_id