CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Screening through questionnairesother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02622529
NCT02622529N/ACompleted

Patients' Conscious Experience and Psychological Consequences of Awake Surgery for Intracerebral Lesions

Cantonal Hospital of St. Gallen·observational·Posted Dec 4, 2015·Updated Jul 18, 2018

In Brief

An observational study evaluating Screening through questionnaires for Fear and 2 related conditions. Completed, enrolled 20 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsFear, Anxiety, Stress
CountriesSwitzerland
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 4, 2015
Enrollment StartNov 1, 2015
Primary CompletionMar 1, 2018
Study CompletionJul 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 10.6 years ago

Interventions

Screening through questionnairesother

Distribution of Questionnaires to every participant within the single existent Arm at three times.