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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01837368
First Posted: April 23, 2013
Last Update Posted: May 10, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Zurich
  Purpose

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 Intervention
Tinnitus Other: observational research

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Research Project About Psychological Strain, Quality of Life and Emotional Awareness in Patients With Tinnitus

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 250
Study Start Date: December 2012
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: observational research
    It is a observational research, no intervention are performed
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with tinnitus
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Switzerland
University Hospital Zurich, Division of Psychiatry and Psychotherapy
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Steffi Weidt, MD University Hospital Zurich, Division of Psychiatry and Psychotherapy
  More Information

Additional Information:
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01837368     History of Changes
Other Study ID Numbers: tinnitus_T0
First Submitted: December 19, 2012
First Posted: April 23, 2013
Last Update Posted: May 10, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms