Loading search results
Sponsor study identifier
observational
20
1 country
1
Study Start
November 2015
Actual (reported)Primary Completion
March 2018
Actual (reported)Study Completion
July 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2015
Actual (reported)November 30, 2015
Actual (reported)December 4, 2015
Actual (reported)March 2018
Actual (reported)July 2018
Actual (reported)Changes in Pain and Anxiety (NRS)
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
1st day preop, intraoperatively, 3rd day postop, 6th month postop
Cognition
1st preoperative day
Changes in General psychological symptoms
1st preoperative day, 3rd day postoperative visit, 6th month postop
Changes in General psychological symptoms
1st preoperative day, 6th month postop
Changes in Stress and Anxiety
1st preoperative day, 3rd day postoperative visit, 6th month postop
Changes in Stress and Anxiety
1st preoperative day, 3rd day postoperative visit, 6th month postop
All of the patients within this single existent Arm will receive the questionnaires.
Distribution of Questionnaires to every participant within the single existent Arm at three times.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Consecutive ongoing recruitment through investigator(s) in daily clinical practice (consultations). The subjects will receive the consent form with an address and phone number indicated where further questions regarding the study can be discussed directly with the project leader. This will take place at least one week before the hospitalisation.
Cantonal Hospital St. Gallen
Sankt Gallen, St.Gallen, 9007, Switzerland
Verordnung über die Humanforschung mit Ausnahme der klinischen Versuche (Humanforschungsverordnung, HFV) / Ordonnance relative à la recherche sur l'être humain à l'exception des essais cliniques (Ordonnance relative à la recherche sur l'être humain, ORH) / Ordinance on Human Research with the Exception of Clinical Trials (Human Research Ordinance, HRO)
von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. PLoS Med. 2007 Oct 16;4(10):e296. doi: 10.1371/journal.pmed.0040296.
Vandenbroucke JP, von Elm E, Altman DG, Gotzsche PC, Mulrow CD, Pocock SJ, Poole C, Schlesselman JJ, Egger M; STROBE Initiative. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): explanation and elaboration. PLoS Med. 2007 Oct 16;4(10):e297. doi: 10.1371/journal.pmed.0040297.
Werner Surbeck, MD
Department of Neurosurgery, Cantonal Hospital St. Gallen, Switzerland
20 participants (actual enrollment reported by the registry).
First Submitted
November 30, 2015
First Posted
December 4, 2015
Study Start
November 2015
Actual (reported)Contact the study team to confirm eligibility.
BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3.
Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
Farrar JT, Portenoy RK, Berlin JA, Kinman JL, Strom BL. Defining the clinically important difference in pain outcome measures. Pain. 2000 Dec 1;88(3):287-294. doi: 10.1016/S0304-3959(00)00339-0.
Folstein MF, Robins LN, Helzer JE. The Mini-Mental State Examination. Arch Gen Psychiatry. 1983 Jul;40(7):812. doi: 10.1001/archpsyc.1983.01790060110016. No abstract available.
Griesel D, Wessa M, Flor H. Psychometric qualities of the German version of the Posttraumatic Diagnostic Scale (PTDS). Psychol Assess. 2006 Sep;18(3):262-8. doi: 10.1037/1040-3590.18.3.262.
Gräfe K, Zipfel S, Herzog W, Löwe B. Screening psychischer Störungen mit dem "Gesundheitsfragebogen für Patienten (PHQ-D)" Daignostica 2004; 50(4): 11
Keefe FJ, Lumley M, Anderson T, Lynch T, Studts JL, Carson KL. Pain and emotion: new research directions. J Clin Psychol. 2001 Apr;57(4):587-607. doi: 10.1002/jclp.1030.
Kremer E, Atkinson HJ, Ignelzi RJ. Measurement of pain: patient preference does not confound pain measurement. Pain. 1981 Apr;10(2):241-248. doi: 10.1016/0304-3959(81)90199-8.
Milian M, Tatagiba M, Feigl GC. Patient response to awake craniotomy - a summary overview. Acta Neurochir (Wien). 2014 Jun;156(6):1063-70. doi: 10.1007/s00701-014-2038-4. Epub 2014 Mar 5.
Radbruch L, Loick G, Kiencke P, Lindena G, Sabatowski R, Grond S, Lehmann KA, Cleeland CS. Validation of the German version of the Brief Pain Inventory. J Pain Symptom Manage. 1999 Sep;18(3):180-7. doi: 10.1016/s0885-3924(99)00064-0.
Primary Completion
March 2018
Actual (reported)Study Completion
July 2018
Actual (reported)Last Updated
July 18, 2018
Record last verified: 2018-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: