An interventional study of Neuro-Music-Therapy according to the Heidelberg Model and Counselling in Tinnitus, sponsored by German Center for Music Therapy Research. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-03-17.
Sponsored by German Center for Music Therapy Research · Not applicable, Interventional, and Treatment
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")
412 studies on the registry are indexed under Tinnitus; 87 are open to participants now.
This study's enrollment of 300 is above the median of 60 across 339 interventional studies indexed under Tinnitus.
Browse Tinnitus studies →German Center for Music Therapy Research is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Neuro-Music-Therapy according to the Heidelberg Model
Behavioral: Neuro-Music-Therapy according to the Heidelberg Model
Counselling
Behavioral: Counselling
The neuro-music therapy according to the Heidelberg Model for tinnitus is a manualized short term music therapeutic treatment lasting for nine consecutive 50-minutes sessions of individualized therapy. Therapy takes place on five consecutive days (from Monday to Friday) with two therapy sessions per day. It comprises both active and receptive forms of music therapy. The interventions are structured into the following modules Directive Counseling, Resonance Training, Neuroauditive Cortex Training, Tinnitus Reconditioning. For more details on the music therapy see Argstatter et al. 2012
Duration: single session of 50 min Tinnitus specific procedures: The counseling group receives the identical counselling procedure as the music therapy group.
Tinnitus Questionnaire (TQ, Goebel and Hiller 1998) Total Score Change From Baseline to End of Treatment
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.
Time frame: average time period was 3 months
Change in Tinnitus Frequency (Pitch), Obtained at Admission (Pre) and After Therapy Intervention (Post)
Time frame: the average time period was 3 months
The trial was announced by press releases in German leading to self-admittance to the Heidelberg Out-patient Center for Tinnitus. It was offered to patients by ENT-doctors in own practice nationwide and to patients attending the ENT-clinic of the university hospital Heidelberg. Recruitment took place between March 2006 and February 2013.
| Milestone | Music Therapy | Counselling |
|---|---|---|
| Started | 146 | 144 |
| Completed | 145 | 144 |
| Not completed | 1 | 0 |
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.
| absolute TF-score change | Music Therapy | Counselling |
|---|---|---|
| Tinnitus Questionnaire (TQ, Goebel and Hiller 1998) Total Score Change From Baseline to End of Treatment | 13.6 ± 7.4 | 3.7 ± 6.8 |
| Hz | Music Therapy | Counselling |
|---|---|---|
| Change in Tinnitus Frequency (Pitch), Obtained at Admission (Pre) and After Therapy Intervention (Post) | 2342 ± 3768 | 530 ± 2036 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Music Therapy | — | — | — |
| Counselling | — | — | — |
| Age, Categorical(Participants) | Music Therapy | Counselling | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 125 | 119 | 244 |
| >=65 years | 21 | 25 | 46 |
| Age, Continuous(years) | Music Therapy | Counselling | Total |
|---|---|---|---|
| Mean | 52.0 ± 11.6 | 53.2 ± 11.9 | 52.5 ± 11.9 |
| Sex: Female, Male(Participants) | Music Therapy | Counselling | Total |
|---|---|---|---|
| Female | 104 | 96 | 200 |
| Male | 42 | 48 | 90 |
| Region of Enrollment(participants) | Music Therapy | Counselling | Total |
|---|---|---|---|
| Germany | 146 | 144 | 290 |
| TQ-score(units on a scale) | Music Therapy | Counselling | Total |
|---|---|---|---|
| Mean | 33.0 ± 14.8 | 32.9 ± 13.4 | 32.9 ± 15.0 |
| Tinnitus Pitch(Hz) | Music Therapy | Counselling | Total |
|---|---|---|---|
| Mean | 5805 ± 2594 | 5851 ± 2678 | 5834 ± 2622 |
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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German Center for Music Therapy Research