Vestibular Schwannoma and Psychological Factors
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Purpose
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 |
|---|
|
Vestibular Schwannoma |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Evaluation of the Influence of Psychological Factors on Balance Control Compensation After Vestibular Schwannoma Surgery |
- psycholgical factors measures [ Time Frame: one year ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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
| Estimated Enrollment: | 50 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | August 2016 |
| Estimated Primary Completion Date: | August 2015 (Final data collection date for primary outcome measure) |
The research protocol is based on 5 evaluation: 3 days before surgery, 8 days, 30 days, 90 days and 360 days after surgery including posturographic tests, videonystagmography and psychological questionnaires at each evaluation.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with vestibular schwanomma with an indication for surgery.
Inclusion Criteria:
- patients with unilateral vestibular schwannoma (stage I to IV according to the Koos classification) with an indication for surgery.
- age between 18 and 75 years
- patients with written informed consent
- patients with Social Security affiliation
Exclusion Criteria:
- patients with psychiatrics pathologies
- ear pathology different from vestibular schwannoma (cholesteatoma of the middle ear, tympanic membrane perforation)
Contacts and Locations| Contact: Cécile Parietti-Winkler, MD, PhD | +33 3 83 85 20 32 | c.parietti@chu-nancy.fr |
| Contact: Gérome GAUCHARD, Phd | +33 3 83 68 39 26 | gerome.gauchard@inserm.fr |
| France | |
| Centre Hospitalier Universitaire de Nancy | Recruiting |
| Nancy, France, 54035 | |
| Contact: Cécile Parietti-Winkler, MD, PhD +33 3 83 85 20 32 c.parietti@chu-nancy.fr | |
| Contact: Gérome Gauchard, PhD +33 3 83 68 39 26 gerome.gauchard@inserm.fr | |
| 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 |
More Information
No publications provided
| Responsible Party: | Cecile PARIETTI-WINKLER, Principal Investigator, Central Hospital, Nancy, France |
| ClinicalTrials.gov Identifier: | NCT01743248 History of Changes |
| Other Study ID Numbers: | 2012-A00522-41 |
| Study First Received: | September 28, 2012 |
| Last Updated: | December 4, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Central Hospital, Nancy, France:
|
vestibular schwannoma balance psychological factors |
Additional relevant MeSH terms:
|
Neurilemmoma Neuroma, Acoustic Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Nerve Sheath Neoplasms Neoplasms, Nerve Tissue Neuroma Peripheral Nervous System Neoplasms Nervous System Neoplasms |
Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Neoplasms by Site Cranial Nerve Neoplasms Vestibulocochlear Nerve Diseases Retrocochlear Diseases Ear Diseases Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Cranial Nerve Diseases |
ClinicalTrials.gov processed this record on June 17, 2013