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Research Project About Psychological Strain, Quality of Life and Emotional Awareness in Patients With Tinnitus

Research Project About Psychological Strain, Quality of Life and Emotional Awareness in Patients With Tinnitus

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01837368
Enrollment
250
Registered
2013-04-23
Start date
2012-12-31
Completion date
2016-05-31
Last updated
2016-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tinnitus

Brief summary

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.

Detailed description

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.

Interventions

It is a observational research, no intervention are performed

Sponsors

University of Zurich
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* all patients older than 18 years with tinnitus who want to participate the investigation during the period of data acquisition

Exclusion criteria

* patients younger than 18 years, * insufficient knowledge of the German language.

Design outcomes

Primary

MeasureTime frameDescription
Values of PRISM4 weeksmeasures the burden of suffering
TAS4 weeksAlexithymia- measured with TAS-toronto alexithymia scale; measures ability to identify feelings, describe feeling, and style of thinking

Secondary

MeasureTime frameDescription
comorbidities4 weeksmeasured with BAI , BDI
Tinnitus functional index (TFI) perceived grade of tinnitus4 weeksComposite outcome
Quality of life (SF-36), perceived grade of tinnitus (THI, TF, TBF-12) and the clinical characteristic of tinnitus.4 weekscomposite outcome

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026