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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01837368
First received: December 19, 2012
Last updated: January 21, 2014
Last verified: January 2014
  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: Retrospective
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 ] [ Designated as safety issue: No ]
    measures the burden of suffering

  • TAS [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    composite outcome

  • comorbidities [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    measured with BAI , BDI


Estimated Enrollment: 200
Study Start Date: December 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01837368

Contacts
Contact: Nicole M Peter, MD +41 (0)44 255 11 11 nicole-martina.peter@usz.ch
Contact: Steffi Weidt, MD steffi.weidt@usz.ch

Locations
Switzerland
University Hospital Zurich, Division of Psychiatry and Psychotherapy Recruiting
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

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01837368     History of Changes
Other Study ID Numbers: tinnitus_T0
Study First Received: December 19, 2012
Last Updated: January 21, 2014
Health Authority: Switzerland: Ethikkommission

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

ClinicalTrials.gov processed this record on September 16, 2014