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Vestibular Schwannoma and Psychological Factors

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ClinicalTrials.gov Identifier: NCT01743248
Recruitment Status : Unknown
Verified December 2012 by Cecile PARIETTI-WINKLER, Central Hospital, Nancy, France.
Recruitment status was:  Recruiting
First Posted : December 6, 2012
Last Update Posted : December 6, 2012
Sponsor:
Collaborator:
University of Lorraine
Information provided by (Responsible Party):
Cecile PARIETTI-WINKLER, Central Hospital, Nancy, France

Tracking Information
First Submitted Date September 28, 2012
First Posted Date December 6, 2012
Last Update Posted Date December 6, 2012
Study Start Date August 2012
Estimated Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 4, 2012)
  • 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Vestibular Schwannoma and Psychological Factors
Official Title Evaluation of the Influence of Psychological Factors on Balance Control Compensation After Vestibular Schwannoma Surgery
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with vestibular schwanomma with an indication for surgery.
Condition Vestibular Schwannoma
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: December 4, 2012)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2016
Estimated Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01743248
Other Study ID Numbers 2012-A00522-41
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Cecile PARIETTI-WINKLER, Central Hospital, Nancy, France
Study Sponsor Central Hospital, Nancy, France
Collaborators University of Lorraine
Investigators
Principal Investigator: Cécile PARIETTI-WINKLER, MD, PhD Central Hospital, Nancy, France
PRS Account Central Hospital, Nancy, France
Verification Date December 2012