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Vestibular Schwannoma and Psychological Factors

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by Cecile PARIETTI-WINKLER, Central Hospital, Nancy, France.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01743248
First Posted: December 6, 2012
Last Update Posted: December 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Lorraine
Information provided by (Responsible Party):
Cecile PARIETTI-WINKLER, Central Hospital, Nancy, France
September 28, 2012
December 6, 2012
December 6, 2012
August 2012
August 2015   (Final data collection date for primary outcome measure)
  • 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)

  • 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
  • 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
Same as current
No Changes Posted
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Vestibular Schwannoma and Psychological Factors
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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Patients with vestibular schwanomma with an indication for surgery.
Vestibular Schwannoma
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
50
August 2016
August 2015   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01743248
2012-A00522-41
Yes
Not Provided
Not Provided
Cecile PARIETTI-WINKLER, Central Hospital, Nancy, France
Central Hospital, Nancy, France
University of Lorraine
Principal Investigator: Cécile PARIETTI-WINKLER, MD, PhD Central Hospital, Nancy, France
Central Hospital, Nancy, France
December 2012