Parkinson's Disease (PD)
Conditions
Keywords
Parkinson's disease, Music therapy, Anthroposophical music therapy, EEG, HRV, Parkinson Anxiety Scale (PAS)
Brief summary
This study aims to examine whether individual music therapy - involving the slow, gentle bowing of a string instrument, accompanied by the music therapist's singing and lyre playing - can have a relaxing and calming effect on patients with Parkinson's disease and improve anxiety, quality of life, and autonomic dysfunction such as unstable blood pressure. People with Parkinson's disease often struggle with anxiety, apathy, and depression, which can severely affect their quality of life. These symptoms are usually difficult to treat adequately with medication. They are frequently associated with dysfunction of the autonomic nervous system and a reduced variability of heart rate. Both are common in Parkinson's disease and can provide clues about stress and well-being. A healthy heart does not beat at completely regular intervals; instead, the time between beats constantly changes slightly. This fluctuation is called heart rate variability (HRV). Primary study outcome will be anxiety. Motivation, depression, individual quality of life, and severity of autonomic symptoms are also assessed using validated questionnaires. Physical study measures will be HRV, along with stability of blood pressure, intensity of tremor, ability to walk, and also electroencephalography (EEG) to assess brain activity. A subproject will explore whether listening to emotionally evocative music can specifically influence the brain in patients with Parkinson's disease (as measured by EEG) and autonomic functions (as measured by HRV). The effectiveness of an emotional response will be measured by a questionnaire (the Geneva Emotional Music Scale).
Interventions
OTHERMusic therapy
Eight weekly individual sessions of music therapy for patients with Parkinson's disease. Part 1 - Listening to lyre music (10 minutes) Participants listen to emotionally stimulating lyre music. Part 2 - Active playing of a string instrument (20 minutes) Participants perform slow, calm bowing of a low string instrument, the Tenor Chrotta (with a pitch range comparable to the cello), guided and supported by the singing of the music therapist.
Sponsors
Siegward -M. Elsas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Parkinson's disease, Hoehn and Yahr stages 1-4 * good understanding of the German language * Signed written informed consent
Exclusion criteria
* Previous music therapy within the last 12 months * Severe hearing impairment * Manifest dementia (MoCA \< 20) * Severe physical disability * Severe somatic or psychiatric illness * Concurrent participation in another clinical trial targeting treatment of Parkinson's disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parkinson Anxiety Scale (PAS) | From four weeks before the first treatment (pre-baseline), immediately before the first treatment (baseline), after weeks 4 and 8 of the weekly treatment, and 4 weeks after the end of therapy (follow-up), through study completion, on average 4 months. | The Parkinson Anxiety Scale (PAS) is a 12-item, Parkinson's disease-specific rating scale that measures anxiety severity across three domains: persistent anxiety, episodic anxiety, and avoidance behavior. Items are rated on a 5-point Likert scale, with higher scores indicating greater anxiety. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geriatric Depression Scale (GDS-15) | From four weeks before the first treatment (pre-baseline), immediately before the first treatment (baseline), after weeks 4 and 8 of the weekly treatment, and 4 weeks after the end of therapy (follow-up), through study completion, on average 4 months. | The Geriatric Depression Scale-15 is a 15-item self-report questionnaire assessing depressive symptoms in older adults. Total scores range from 0 to 15, with higher scores indicating greater depression severity. |
| Scales for Outcomes in Parkinson's disease - Autonomic Dysfunction (SCOPA-AUT) | From four weeks before the first treatment (pre-baseline), immediately before the first treatment (baseline), after weeks 4 and 8 of the weekly treatment, and 4 weeks after the end of therapy (follow-up), through study completion, on average 4 months. | The Scales for Outcomes in Parkinson's Disease - Autonomic Dysfunction (SCOPA-AUT) is a 26-item self-report questionnaire assessing autonomic symptoms in patients with Parkinson's disease. Total scores range from 0 to 69, with higher scores indicating greater autonomic dysfunction. |
| General Self-Efficacy Scale (SWE) | From four weeks before the first treatment (pre-baseline), immediately before the first treatment (baseline), after weeks 4 and 8 of the weekly treatment, and 4 weeks after the end of therapy (follow-up), through study completion, on average 4 months. | The General Self-Efficacy Scale is a 10-item self-report questionnaire assessing optimistic beliefs about coping with difficult demands, problem solving, and adaptation to stressful life events. Total scores range from 10 to 40, with higher scores indicating greater general self-efficacy. |
| Apathy Evaluation Scale (AES) | From four weeks before the first treatment (pre-baseline), immediately before the first treatment (baseline), after weeks 4 and 8 of the weekly treatment, and 4 weeks after the end of therapy (follow-up), through study completion, on average 4 months. | The Apathy Evaluation Scale (AES) is an 18-item rating scale assessing apathy. Total scores range from 18 to 72, with higher scores indicating greater apathy. |
| Schedule for the Evaluation of Individual Quality of Life (SEIQoL-Q) | From four weeks before the first treatment (pre-baseline), immediately before the first treatment (baseline), after weeks 4 and 8 of the weekly treatment, and 4 weeks after the end of therapy (follow-up), through study completion, on average 4 months. | The Schedule for the Evaluation of Individual Quality of Life (SEIQoL-Q) is a 24-item rating scale assessing quality of life. Items are rated from from 0% to 100%, with higher scores indicating greater quality of life. |
| Multidimensional Mood Questionnaire (MDBF) | from the beginning of a therapy session to the end of a therapy session, on average over 45 minutes | The Multidimensional Mood Questionnaire (MDBF) is a 12-item questionnaire used to assess current well-being before and after a music therapy session. Items are assessed on a 5-point Likert Scale form 1-5, with higher scores indicating stronger moods (positive or negative). |
| Heart Rate Variability (HRV) | from onset of a therapy session to the end of a therapy session (avg. 45 min.), and 4 weeks before the 1st treatment, immediately before the 1st treatment, after weeks 4 and 8 of the weekly treatment, and 4 weeks after end of therapy (average 4 months). | The degree of heart rate variability correlates with well-being, with lower values indicating an increase in stress and anxiety. |
Countries
Switzerland
Contacts
CONTACTSiegward Elsas, Dr. med.
CONTACTTiffany Huber, Msc.
PRINCIPAL_INVESTIGATORSiegward Elsas, Dr. med.
Klinik Arlesheim
Outcome results
None listed