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Neuro-Music-Therapy for Patients With Chronic Tinnitus - a Controlled Clinical Trial

Not Applicable
Completed
Conditions
Tinnitus
Interventions
Behavioral: Neuro-Music-Therapy according to the Heidelberg Model
Behavioral: Counselling
Registration Number
NCT01845155
Lead Sponsor
German Center for Music Therapy Research
Brief Summary

BACKGROUND: Tinnitus is a nonspecific symptom of hearing disorder characterized by the sensation of buzzing, ringing, clicking, pulsations, and other noises in the ear. Despite a variety of treatments, many patients with chronic tinnitus ask for more active ways in coping with their tinnitus. Gold standard treatment in chronic tinnitus is a comprehensive directive counseling explaining the underlying mechanisms leading to the tinnitus percept. Therefore a neuro-music therapeutic treatment based on a bio-psycho-social framework was developed and compared to a counselling-only control group.

INTERVENTION: two standardized protocols for tinnitus therapy were defined ("neuro-music therapy" vs. "counselling")

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
300
Inclusion Criteria
  • Clinical diagnosis of chronic tinnitus persisting for a minimum of 6 month
  • Adults, aged 18 or over
  • Patients are able to understand, read and speak German fluently
  • Patients are able to give written informed consent
  • tinnitus with determinable centre frequency
Exclusion Criteria
  • Tinnitus related to anatomic lesions of the ear, to retrocochlear lesions or to cochlear implantation
  • Tinnitus is concomitant symptom of a known systemic disease (such as Menière's Disease, vestibular schwannoma, endolymphatic hydrops)
  • Status following craniocerebral trauma, cervicogenic or stomatognathic tinnitus
  • Tinnitus is neither noisiform nor tonal (cricking, clacking, rumbling) or has different sound components or is pulsatile, intermittent or non-persistent
  • Severe hearing impairment (greater than 50 decibel hearing loss (dB HL) in the region of the centre tinnitus frequency)
  • Severe hyperacusis
  • One or two sided deafness
  • Clinical diagnosis of severe mental disorder or psychiatric or neurological disease (psychosis, epilepsy, Parkinsons's disease, dementia, alcohol or drug abuse)
  • History of severe ischemic disorder (previous stoke, previous heart attack, peripheral arterial occlusion disease)
  • Inability to discontinue drugs known to be associated with tinnitus (high-dose aspirin, quinidine, aminoglycosides) or psychotropic medication prior to entry into the study
  • Patients are not able to understand, read and speak German fluently
  • Patients are not able to give written informed consent

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Music TherapyNeuro-Music-Therapy according to the Heidelberg ModelNeuro-Music-Therapy according to the Heidelberg Model
CounsellingCounsellingCounselling
Primary Outcome Measures
NameTimeMethod
Tinnitus Questionnaire (TQ, Goebel and Hiller 1998) Total Score Change From Baseline to End of Treatmentaverage time period was 3 months

Tinnitus severity was assessed by the German version of the tinnitus questionnaire (TQ, Goebel and Hiller 1994). The TQ consists of a total of 52 items. The questionnaire records tinnitus related complaints on a global TQ-score. The range of values is between the minimum score of 0 and the maximum score of 84, whereas high values indicate high tinnitus related distress.

Secondary Outcome Measures
NameTimeMethod
Change in Tinnitus Frequency (Pitch), Obtained at Admission (Pre) and After Therapy Intervention (Post)the average time period was 3 months

Trial Locations

Locations (1)

German Center for Music Therapy Research

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Heidelberg, Baden-Württemberg, Germany

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