Patients' Conscious Experience and Psychological Consequences of Awake Surgery for Intracerebral Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Changes in Pain and Anxiety (NRS)
研究概览
简要总结
This study aims to investigate patients' experience of awake surgery of the brain. Patients therefore must suffer a disease that makes the technique of awake craniotomy necessary.
In more detail, the investigators are performing this study in order to investigate the influence of fear on pain perception during surgery for patients undergoing awake surgery for lesions within the brain. In the event of finding a correlation between fear of the surgery and intraoperative pain perception, the investigators aim to reduce possible fear beforehand.
An additional goal of the investigators is to identify psychological consequences of awake craniotomy timely and admit patients to an adequate therapy if necessary.
There will be no changes regarding the actual treatment of the disease. In case of a consent, the patient will receive questionnaires at three timepoints: 1. day before surgery. 2. third day after surgery. 3. at 3-6 months postoperatively at the outpatient clinics.
The benefit of participating in this study is the possibility of detecting psychological consequences of awake craniotomy at an early stage. If required, patients will then receive treatment timely.
There are no additional risks. Theoretically there is only a data risk after analysis.
Patients are free to decide if they want to participate within this study. There are no changes in the actual treatment if patients deny participation. In case of participation, patients have the right to quit at any time with no reasoning at all.
During the study investigators are collecting health-related data. If patients quit before the study end, data will still be used in pseudonymized form. After 10 years, data will be destroyed.
In case of participation the only duty for the patient is to fill out the questionnaires at the above mentioned three time points.
The investigators conduct this study based on all rules of law regarding data protection. Investigators only use the collected data in relation to this study. All investigators are under obligation to secrecy.
详细描述
ETHICAL AND REGULATORY ASPECTS
Ethical Conduct of Study
The research project will be carried out in accordance to the research plan and with principles enunciated in the current version of the Declaration of Helsinki (DoH), the Essentials of Good Epidemiological Practice issued by Public Health Switzerland (EGEP), the Swiss Law and Swiss regulatory authority's requirements as applicable. The EC and regulatory authorities will be informed about project start and termination.
The Project Leader of this Project Leader initiated Trial acknowledges his responsibilities as both the Investigator and the Project Leader.
Risk categorisation
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Low grade glioma, cavernoma, metastasis
- •age ≥ 18 years < 65 years
排除标准
- •No given operability for anaesthetic reasons.
结局指标
主要结局
Changes in Pain and Anxiety (NRS)
时间窗: 1st day preop, intraoperatively, 3rd day postop, 6th month postop
Numeric rating scale (NRS). (Kremer et al., 1981; Farrar et al., 2000) Preoperative assessment of anxiety is evaluated using the NRS on a scale of 0-10. Intraoperatively the NRS is used at three time points to assess for anxiety and pain. 0 indicates the absence of pain or anxiety, whereas 10 indicates the maximum possible patients' perception of pain or anxiety
次要结局
- Cognition(1st preoperative day)
- Changes in Stress and Anxiety(1st preoperative day, 3rd day postoperative visit, 6th month postop)
- Changes in Pain(1st preoperative day, 3rd day postoperative visit, 6th month postop)
- Changes in General psychological symptoms(1st preoperative day, 6th month postop)
研究者
Nader Hejrati
med. pract.
Cantonal Hospital of St. Gallen