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

Tinnitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01837368
• Other study ID #: tinnitus_T0
• Status: Completed
• Phase: N/A
• First received: December 19, 2012
• Last updated: May 9, 2016
• Start date: December 2012
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Tinnitus

Intervention

Other:
• observational research
It is a observational research, no intervention are performed

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Division of Psychiatry and Psychotherapy	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Values of PRISM	measures the burden of suffering	4 weeks	No
Primary	TAS	Alexithymia- measured with TAS-toronto alexithymia scale; measures ability to identify feelings, describe feeling, and style of thinking	4 weeks	No
Secondary	Quality of life (SF-36), perceived grade of tinnitus (THI, TF, TBF-12) and the clinical characteristic of tinnitus.	composite outcome	4 weeks	No
Secondary	comorbidities	measured with BAI , BDI	4 weeks	No
Secondary	Tinnitus functional index (TFI) perceived grade of tinnitus	Composite outcome	4 weeks	No

External Links

•   Publication Tinnitus and PRISM
•   Publication Tinnitus and quality of life