Vestibular Schwannoma and Psychological Factors

December 4, 2012 updated by: Cecile PARIETTI-WINKLER, Central Hospital, Nancy, France

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

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nancy, France, 54035
        • Recruiting
        • Centre Hospitalier Universitaire de Nancy
        • Sub-Investigator:
          • Philippe Perrin, MD, PhD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Gerome GAUCHARD, PhD
        • Sub-Investigator:
          • Elisabeth SPITZ, PhD
        • Sub-Investigator:
          • Laurence RIBEYRE
        • Sub-Investigator:
          • Alexis LION, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with vestibular schwanomma with an indication for surgery.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
one year
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
one year
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
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Collaborators

University of Lorraine

Investigators

  • Principal Investigator: Cécile Parietti-Winkler, MD, PhD, Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Anticipated)

August 1, 2015

Study Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

September 28, 2012

First Submitted That Met QC Criteria

December 4, 2012

First Posted (Estimate)

December 6, 2012

Study Record Updates

Last Update Posted (Estimate)

December 6, 2012

Last Update Submitted That Met QC Criteria

December 4, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-A00522-41

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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