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

NCT02622529 | Completed

• 1 other identifier: EKSG 15/157
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fear; Anxiety; Stress

Keywords

Awake craniotomy; Psychological consequences; Fear and Anxiety

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• 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

Study Arms (1)

Screening through Questionnaires

All of the patients within this single existent Arm will receive the questionnaires.

Other: Screening through questionnaires

Interventions

Screening through questionnaires OTHER

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

Screening through Questionnaires

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Written informed consent
• Low grade glioma, cavernoma, metastasis
• age ≥ 18 years \< 65 years

You may not qualify if:

• No given operability for anaesthetic reasons.

Sponsors & Collaborators

• Cantonal Hospital of St. Gallen: lead

Study Sites (1)

Cantonal Hospital St. Gallen

Sankt Gallen, St.Gallen, 9007, Switzerland

Location

Related Publications (14)

• 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)

  BACKGROUND

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  PMID: 17941714 BACKGROUND

• 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.

  PMID: 17941715 BACKGROUND

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  PMID: 13688369 BACKGROUND

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  PMID: 11832252 BACKGROUND

• Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.

  PMID: 8080219 BACKGROUND

• 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.

  PMID: 11068116 BACKGROUND

• 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.

  PMID: 6860082 BACKGROUND

• 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.

  PMID: 16953729 BACKGROUND

• Gräfe K, Zipfel S, Herzog W, Löwe B. Screening psychischer Störungen mit dem "Gesundheitsfragebogen für Patienten (PHQ-D)" Daignostica 2004; 50(4): 11

  BACKGROUND

• 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.

  PMID: 11255208 BACKGROUND

• 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.

  PMID: 7267140 BACKGROUND

• 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.

  PMID: 24595540 BACKGROUND

• 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.

  PMID: 10517039 BACKGROUND

Related Links

• Declaration of Helsinki, Version November 2013
• Essentials of Good Epidemiological Practice
• Human Research Act, Federal Law about Research involving Human Subjects

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Werner Surbeck, MD

  Department of Neurosurgery, Cantonal Hospital St. Gallen, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: med. pract.

Study Record Dates

• First Submitted: November 30, 2015
• First Posted: December 4, 2015
• Study Start: November 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: July 1, 2018
• Last Updated: July 18, 2018

Record last verified: 2018-07

Locations

CH (1)