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Идёт набор NCT07734181

Music Therapy in Parkinson's Disease

Без фазы С лечением Parkinson's Disease (PD)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Music therapy.
Кому может быть актуально
Состояния в реестре: Parkinson's Disease (PD). Базовые параметры: 50 лет — 79 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Швейцария
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Harmonization of Breathing Through Music Therapy and Its Impact on Anxiety, Quality of Life, and Autonomic Dysfunction in Parkinson's Disease

Обзор

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).

Вмешательства

  • Другое Music 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.

Первичные конечные точки

  • Parkinson Anxiety Scale (PAS) [Срок оценки: 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.]
Вторичные конечные точки (7)
  • Geriatric Depression Scale (GDS-15) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: from the beginning of a therapy session to the end of a therapy session, on average over 45 minutes]
  • Heart Rate Variability (HRV) [Срок оценки: 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).]

Критерии участия

Критерии включения

  • Parkinson's disease, Hoehn and Yahr stages 1-4
  • good understanding of the German language
  • Signed written informed consent

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Швейцария · 1 центр
  • Klinik Arlesheim AG — Arlesheim

Идентификаторы

NCT: NCT07734181 · 2026-00839

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗