Pain, Stress
Conditions
Keywords
Pain, Stress, AVWF, Audio-Visual-Perception-Enhancement
Brief summary
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.
Interventions
DEVICEAVWF device
The AVWF method utilizes sound modulated music, which is thought to regulate the vagus nerve.
Sponsors
Klinikum Klagenfurt am Wörthersee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* chronic low back pain with a numeric rating scale of pain \>= 4 for \> 6 month * patients \>18 years
Exclusion criteria
* psychosis * drug addiction * pension process * pregnant women * epilepsy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Numeric Rating Scale of Pain Severity | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Anxiety and Depression Scale | Change from baseline Hospital Anxiety and Depression Scale after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention | 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). |
| Pittsburgh Sleep Quality Index | Change from baseline Pittsburgh Sleep Quality Index after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention | Self-report questionnaire that assesses sleep Quality through the measure of 19 individual items, creating 7 components that produce one global score |
| Health related quality of life | Change from baseline health related quality of life after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention | Health related quality of life will be measured by euroQol-5D questionnaire. It contains two sections, a descriptive section and a valuation section |
| Pain Disability Index | Change from baseline Pain Disability Index after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention | 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 |
| Salival Cortisol level | Change from baseline salival cortisol level after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention | Immunoassay for in vitro quantitative determination of cortisol in saliva |
| Depression Anxiety Stress Scales | Change from baseline Depression Anxiety Stress Scales after 10 interventions, 4 weeks after the last intervention, and 3 month after the last intervention | A 42-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress. |
Countries
Austria
Outcome results
None listed