Vestibular Schwannoma and Psychological Factors

• Conditions: Vestibular Schwannoma

• Registration Number: NCT01743248
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-09-28
• Status Verified: 2012-12
• Study First Submitted QC: 2012-12-04
• Last Update Submitted: 2012-12-04
• Study First Posted: 2012-12-06
• Last Update Posted: 2012-12-06
• Primary Completion: 2015-08
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
psycholgical factors measures	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	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	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

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Nancy; 🇫🇷 Nancy, France