Research Project About Psychological Strain, Quality of Life and Emotional Awareness in Patients With Tinnitus
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|ClinicalTrials.gov Identifier: NCT01837368|
Recruitment Status : Completed
First Posted : April 23, 2013
Last Update Posted : May 10, 2016
Validation of PRISM (Pictorial Representation of Illness and Self Measure) as a assessment of quality of life and suffering in patients with tinnitus.
Association between experiencing, verbalizing and regulating emotions and perceived tinnitus.
Correlation analysis are used to search for connections between the subjective behavioral outcomes mentioned above and the objective EEG-patterns.
|Condition or disease||Intervention/treatment|
|Tinnitus||Other: observational research|
Validation of PRISM (Pictorial Representation of Illness and Self Measure). Assessment of quality of life and suffering in patients with tinnitus in an observational study using different questionnaires. (THI, TF, TBF-12, BDI, BAI, SF-36).
THI - Tinnitus Handicap Inventory
TF - Tinnitus Questionnaire after Goebel and Hiller
TBF-12 - Tinnitus Impairment Questionnaire
BDI - Beck Depression Inventory
BAI - Beck Anxiety Inventory
SF-36 - Short Form 36 Health Survey Questionnaire
Association between experiencing, verbalizing and regulating emotions and perceived tinnitus using the TAS-20 (20-Item Toronto Alexithymia Scale) and the above mentioned questionnaires.
EEG-studies on the spontaneous brain activity of individuals affected by tinnitus consistently report differences in the composition of the EEG-frequency spectrum between individuals with tinnitus and healthy controls. Furthermore it has been shown that not only the auditory cortex but other regions of the brain are involved in the perception of the chronic ear noise as well. Among them is the limbic system which is associated with the emotional processing of the human brain.
Correlation analysis are used to search for connections between the subjective behavioral outcomes mentioned above and the objective EEG-patterns. Aim of the current study is to provide conclusive models of associated assessments of the psychological strain end emotional stress of individuals suffering from tinnitus and objective EEG-analysis.
|Study Type :||Observational|
|Actual Enrollment :||250 participants|
|Official Title:||Research Project About Psychological Strain, Quality of Life and Emotional Awareness in Patients With Tinnitus|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
- Other: observational research
It is a observational research, no intervention are performed
- Values of PRISM [ Time Frame: 4 weeks ]measures the burden of suffering
- TAS [ Time Frame: 4 weeks ]Alexithymia- measured with TAS-toronto alexithymia scale; measures ability to identify feelings, describe feeling, and style of thinking
- Quality of life (SF-36), perceived grade of tinnitus (THI, TF, TBF-12) and the clinical characteristic of tinnitus. [ Time Frame: 4 weeks ]composite outcome
- comorbidities [ Time Frame: 4 weeks ]measured with BAI , BDI
- Tinnitus functional index (TFI) perceived grade of tinnitus [ Time Frame: 4 weeks ]Composite outcome
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01837368
|University Hospital Zurich, Division of Psychiatry and Psychotherapy|
|Zurich, ZH, Switzerland, 8091|
|Principal Investigator:||Steffi Weidt, MD||University Hospital Zurich, Division of Psychiatry and Psychotherapy|