Tinnitus
Conditions
Keywords
Tinnitus, music therapy, directive counselling, acoustic stimulation, group comparison, subjective evaluation, pitch
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)
Interventions
BEHAVIORALNeuro-Music-Therapy according to the Heidelberg Model
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
BEHAVIORALCounselling
Duration: single session of 50 min Tinnitus specific procedures: The counseling group receives the identical counselling procedure as the music therapy group.
Sponsors
German Center for Music Therapy Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tinnitus Questionnaire (TQ, Goebel and Hiller 1998) Total Score Change From Baseline to End of Treatment | average 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
| Measure | Time frame |
|---|---|
| Change in Tinnitus Frequency (Pitch), Obtained at Admission (Pre) and After Therapy Intervention (Post) | the average time period was 3 months |
Countries
Germany
Participant flow
Recruitment details
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.
Pre-assignment details
complete audiometric and psychological profile (exclusion of 10 patients due to incomplete data)
Participants by arm
| Arm | Count |
|---|---|
| Music Therapy Neuro-Music-Therapy according to the Heidelberg Model
Neuro-Music-Therapy according to the Heidelberg Model : 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 | 146 |
| Counselling Counselling
Counselling : Duration: single session of 50 min Tinnitus specific procedures: The counseling group receives the identical counselling procedure as the music therapy group. | 144 |
| Total | 290 |
Baseline characteristics
| Characteristic | Counselling | Total | Music Therapy |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 25 Participants | 46 Participants | 21 Participants |
| Age, Categorical Between 18 and 65 years | 119 Participants | 244 Participants | 125 Participants |
| Age, Continuous | 53.2 years STANDARD_DEVIATION 11.9 | 52.5 years STANDARD_DEVIATION 11.9 | 52.0 years STANDARD_DEVIATION 11.6 |
| Region of Enrollment Germany | 144 participants | 290 participants | 146 participants |
| Sex: Female, Male Female | 96 Participants | 200 Participants | 104 Participants |
| Sex: Female, Male Male | 48 Participants | 90 Participants | 42 Participants |
| Tinnitus Pitch | 5851 Hz STANDARD_DEVIATION 2678 | 5834 Hz STANDARD_DEVIATION 2622 | 5805 Hz STANDARD_DEVIATION 2594 |
| TQ-score | 32.9 units on a scale STANDARD_DEVIATION 13.4 | 32.9 units on a scale STANDARD_DEVIATION 15 | 33.0 units on a scale STANDARD_DEVIATION 14.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Music Therapy | Tinnitus Questionnaire (TQ, Goebel and Hiller 1998) Total Score Change From Baseline to End of Treatment | 13.6 absolute TF-score change | Standard Deviation 7.4 |
| Counselling | Tinnitus Questionnaire (TQ, Goebel and Hiller 1998) Total Score Change From Baseline to End of Treatment | 3.7 absolute TF-score change | Standard Deviation 6.8 |
Secondary
Change in Tinnitus Frequency (Pitch), Obtained at Admission (Pre) and After Therapy Intervention (Post)
Time frame: the average time period was 3 months
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Music Therapy | Change in Tinnitus Frequency (Pitch), Obtained at Admission (Pre) and After Therapy Intervention (Post) | 2342 Hz | Standard Deviation 3768 |
| Counselling | Change in Tinnitus Frequency (Pitch), Obtained at Admission (Pre) and After Therapy Intervention (Post) | 530 Hz | Standard Deviation 2036 |