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It is anticipated that Audio-Visual-Perception-Enhancement (AVWF®) method leads to pain reduction and a decrease of inflammatory markers in chronic pain patients. Also an improvement of quality of life, self-perceived disability and depression in chronic pain patients is expected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modulated | Experimental | modulated music |
|
| Typical | Sham Comparator | typical music |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVWF device | Device | The AVWF method utilizes sound modulated music, which is thought to regulate the vagus nerve. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Numeric Rating Scale of Pain Severity | Validated 11 pt scale 0-10, to evaluate a patient's current severity of pain. A rating of 0 indicates no pain while 10 indicates the worst pain imaginable. A score of 4 or above is considered a clinically significant pain Level. | Change from baseline Numeric Rating Scale of Pain Severity after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Health related quality of life | Health related quality of life will be measured by euroQol-5D questionnaire. It contains two sections, a descriptive section and a valuation section | Change from baseline health related quality of life after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rudolf Likar | Head of department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Klagenfurt am Wörthersee | Klagenfurt | 9020 | Austria |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Hospital Anxiety and Depression Scale |
Anxiety and depression is evaluated by the the Hospital Anxiety and Depression Scale.It contains 14 items describing symptoms of depression (7 items) and anxiety (7 items). It was developed to identify anxiety and depression in non-psychiatric medical outpatients. Each item on the HADS is scored from 0 (no problem) to 3 (maximum distress). |
| Change from baseline Hospital Anxiety and Depression Scale after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention |
| Pittsburgh Sleep Quality Index | Self-report questionnaire that assesses sleep Quality through the measure of 19 individual items, creating 7 components that produce one global score | Change from baseline Pittsburgh Sleep Quality Index after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention |
| Depression Anxiety Stress Scales | A 42-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress. | Change from baseline Depression Anxiety Stress Scales after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention |
| Pain Disability Index | The Pain Disability Index is an instrument for measuring the impact that pain has on the ability of a person to participate in essential life activities. Minimal index: 0; maximal index: 70; The higher the index the greater the person's disability due to pain | Change from baseline Pain Disability Index after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention |
| Salival Cortisol level | Immunoassay for in vitro quantitative determination of cortisol in saliva | Change from baseline salival cortisol level after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention |