Harmonization of Breathing Through Music Therapy and Its Impact on Anxiety, Quality of Life, and Autonomic Dysfunction in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Parkinson Anxiety Scale (PAS)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parkinson's disease, Hoehn and Yahr stages 1-4
- •good understanding of the German language
- •Signed written informed consent
排除标准
- •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
研究组 & 干预措施
Music therapy intervention
干预措施: Music therapy (Other)
结局指标
主要结局
Parkinson Anxiety Scale (PAS)
时间窗: 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.
次要结局
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- Multidimensional Mood Questionnaire (MDBF)(from the beginning of a therapy session to the end of a therapy session, on average over 45 minutes)
- 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).)
研究者
Siegward -M. Elsas
Principal Investigator
Klinik Arlesheim