Vestibular Schwannoma and Psychological Factors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01743248|
Recruitment Status : Unknown
Verified December 2012 by Cecile PARIETTI-WINKLER, Central Hospital, Nancy, France.
Recruitment status was: Recruiting
First Posted : December 6, 2012
Last Update Posted : December 6, 2012
The surgery of a vestibular schwannoma induces balance disorders which have a an impact on the patient's daily life and disrupt their quality of life.
But the balance disorders don't seem to be the only ones factors that impaired the patient's quality of life. It has been alrealdy shown that emotional and psychological factors are also related to patient's quality of life.
This study evaluates the relationship between the balance control compensation and these factors (i.e. emotional and psychological) in the vestibular schwannoma resection process.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Evaluation of the Influence of Psychological Factors on Balance Control Compensation After Vestibular Schwannoma Surgery|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||August 2015|
|Estimated Study Completion Date :||August 2016|
- psycholgical factors measures [ Time Frame: one year ]
The same evaluation protocole will be performed 5 times (3 days before surgery, 8 days, 30 days, 90 days and one year after surgery), with this measures:
-score of psychological questionnaires:Revised NEO Personality Inventory (NEO PI-R), Bref Cope (coping questionnaire), Revised Illness Perception Questionnaire (IPQ-R),World Health Organisation quality of life(WHOQOL-Bref) and Hospital Anxiety and Depression Scale (HADS)
- balance control performance [ Time Frame: one year ]The same evaluation protocole will be performed 5 times (3 days before surgery, 8 days, 30 days, 90 days and one year after surgery), with the measures of the score of balance performance with sensory organisation test
- vestibular performance [ Time Frame: one year ]The same evaluation protocole will be performed 5 times (3 days before surgery, 8 days, 30 days, 90 days and one year after surgery), with the measures of the score of vestibular performance with videonystagmography
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01743248
|Contact: Cécile Parietti-Winkler, MD, PhD||+33 3 83 85 20 firstname.lastname@example.org|
|Contact: Gérome GAUCHARD, Phd||+33 3 83 68 39 email@example.com|
|Centre Hospitalier Universitaire de Nancy||Recruiting|
|Nancy, France, 54035|
|Contact: Cécile Parietti-Winkler, MD, PhD +33 3 83 85 20 32 firstname.lastname@example.org|
|Contact: Gérome Gauchard, PhD +33 3 83 68 39 26 email@example.com|
|Sub-Investigator: Gerome GAUCHARD, PhD|
|Sub-Investigator: Philippe PERRIN, MD, PhD|
|Sub-Investigator: Elisabeth SPITZ, PhD|
|Sub-Investigator: Laurence RIBEYRE|
|Sub-Investigator: Alexis LION, PhD|
|Principal Investigator:||Cécile PARIETTI-WINKLER, MD, PhD||Central Hospital, Nancy, France|