Vestibular Schwannoma and Psychological Factors

Vestibular Schwannoma Clinical Trial

Official title:

Evaluation of the Influence of Psychological Factors on Balance Control Compensation After Vestibular Schwannoma Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01743248
• Other study ID #: 2012-A00522-41
• Status: Recruiting
• Phase: N/A
• First received: September 28, 2012
• Last updated: December 4, 2012
• Start date: August 2012
• Est. completion date: August 2016

Study information

• Verified date: December 2012
• Source: Central Hospital, Nancy, France
• Contact: Cécile Parietti-Winkler, MD, PhD
• Phone: +33 3 83 85 20 32
• Email: c.parietti[@]chu-nancy.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Neurilemmoma
• Neuroma, Acoustic
• Vestibular Schwannoma

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Nancy	Nancy

Sponsors (2)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France	University of Lorraine

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	psycholgical factors measures	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)	one year	No
Primary	balance control performance	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	one year	No
Primary	vestibular performance	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	one year	No