Vestibular Schwannoma and Psychological Factors

NCT01743248 | Unknown DMC

• 1 other identifier: 2012-A00522-41
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Vestibular Schwannoma

Keywords

vestibular schwannoma; balance; psychological factors

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with vestibular schwanomma with an indication for surgery.

You may qualify if:

• 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

You may not qualify if:

• patients with psychiatrics pathologies
• ear pathology different from vestibular schwannoma (cholesteatoma of the middle ear, tympanic membrane perforation)

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead
• University of Lorraine: collaborator

Study Sites (1)

Centre Hospitalier Universitaire de Nancy

Nancy, Nancy, 54035, France

RECRUITING

MeSH Terms

Conditions

Neuroma, Acoustic

Condition Hierarchy (Ancestors)

Neurilemmoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Cranial Nerve Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Peripheral Nervous System Neoplasms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases; Nervous System Diseases

Study Officials

• Cécile PARIETTI-WINKLER, MD, PhD

  Central Hospital, Nancy, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cécile Parietti-Winkler, MD, PhD

CONTACT

+33 3 83 85 20 32; c.parietti@chu-nancy.fr

Gérome GAUCHARD, Phd

CONTACT

+33 3 83 68 39 26; gerome.gauchard@inserm.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 28, 2012
• First Posted: December 6, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2016
• Last Updated: December 6, 2012

Record last verified: 2012-12

Locations

FR (1)