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

May 9, 2016 updated by: University of Zurich

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • ZH
      • Zurich, ZH, Switzerland, 8091
        • University Hospital Zurich, Division of Psychiatry and Psychotherapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with tinnitus

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Values of PRISM
Time Frame: 4 weeks
measures the burden of suffering
4 weeks
TAS
Time Frame: 4 weeks
Alexithymia- measured with TAS-toronto alexithymia scale; measures ability to identify feelings, describe feeling, and style of thinking
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 weeks
comorbidities
Time Frame: 4 weeks
measured with BAI , BDI
4 weeks
Tinnitus functional index (TFI) perceived grade of tinnitus
Time Frame: 4 weeks
Composite outcome
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Steffi Weidt, MD, University Hospital Zurich, Division of Psychiatry and Psychotherapy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

May 1, 2016

Study Registration Dates

First Submitted

December 19, 2012

First Submitted That Met QC Criteria

April 22, 2013

First Posted (ESTIMATE)

April 23, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 10, 2016

Last Update Submitted That Met QC Criteria

May 9, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tinnitus_T0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tinnitus

Clinical Trials on observational research

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe