Evaluation of the Influence of Psychological Factors on Balance Control Compensation After Vestibular Schwannoma Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- psycholgical factors measures
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •patients with psychiatrics pathologies
- •ear pathology different from vestibular schwannoma (cholesteatoma of the middle ear, tympanic membrane perforation)
结局指标
主要结局
psycholgical factors measures
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
未报告次要终点
研究者
Cecile PARIETTI-WINKLER
Principal Investigator
Central Hospital, Nancy, France