Clinical trial NCT05379062: Choral Singing for Patients With Parkinson's
Official title: Singing in a Group Compared to Receptive Music and Treatment as a Usual Condition in Patients With Parkinson's Disease: A Randomized Controlled Trial to Develop Guidelines/Recommendations for Efficient Use
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson
Keywords: Parkinson
Singing
Music
Stress
Cortisol
Depression
Lead sponsor: University of Salzburg
Sponsor class: OTHER
Collaborators: name: University of Vienna
name: Confraternität Private Hospital
First posted: 2022-05-18
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental group (singing in a group/active) Experimental group (receptive music/auditive) Control group (treatment as usual condition)
Primary purpose: BASIC_SCIENCE

Brief summary: Study Design: Multi-centered, open, prospective, three-arm, randomized, controlled parallel-group study;

Study Participants: Adult patients with Parkinson's disease in Salzburg (and surroundings) and Vienna (and surroundings);

Planned Sample Size: Experimental Group 1 (singing in a group/active): 30 persons; Experimental group 2 (receptive music/auditive): 30 persons; Control group (treatment as usual condition): 30 persons;

Planned Duration of Study: Recruitment: spring 2022, study duration: spring 2022 to autumn 2022, evaluation phase and publication: autumn-summer 2022/2023;

Primary Objectives: Reduction of depression, anxiety and physiological stress; Measurement of the Endpoints: Hospital Anxiety and Depression Scale - German Version (HADS-D), Biochemical determination: cortisol and alpha-amylase (concentration measurement in saliva).

Detailed description: Parkinson's disease is predominantly a disease of old age. A total of about 16,000 patients suffer from Parkinson's disease in Austria. This corresponds to about 0.1% of the population over 50 years of age. In addition to motor and language deficits, psychological deficits also occur. These are usually found between the ages of 50 and 60. The lack of dopamine is the main basis of modern Parkinson therapy. The physiological part of Parkinson's disease can today be well-controlled with medication. Significantly better results can only be achieved with accompanying music-related interventions. For example, regular group singing under professional guidance seems advantageous. The music-induced, rhythmic movement associated with singing, the active posture, the more differentiated strain on the vocal apparatus and breathing compared to speaking, and last but not least, the predominantly positive affectivity show that singing is a complex, ecologically valid form of interpersonal interaction that is also effective on a psychosocial level. In short, many of the therapeutic goals relevant to people with Parkinson's disease are likely to be better achieved through this group activity. Singing together stimulates numerous physical systems as well as perception, attention and cognition. Synchronised movements have also been associated in various studies with increased pain tolerance and may be beneficial in maintaining motor performance in people with Parkinson's disease. Singing improves the immune defence of many patients according to further systematic observations. The results show clear improvements in various health indicators, also in a sustainable course. In addition, regular listening to specifically selected stimulating music, as compiled on a new CD (ISBN: 978-3-9502441-2-0) produced by the project submitter's research group, leads to increased blood flow to certain brain areas. Among other things, dopamine is released. In case of sudden blockages, the pointed rhythm of the Radetzky March, recorded on the CD, helps in a rapid way that could not be achieved with any medication in such a short time.

The aim of this randomized study is to investigate the effect of group singing on the improvement of symptoms of Parkinson's disease, depression, anxiety and stress. Furthermore, the quality of life and the course of parkinson's disease will be assessed. It must also be clarified how often choral singing can be rehearsed in a meaningful way before a weakening (tolerance) of the effect occurs and how high the patients' compliance is. To objectify this study, three groups will be randomly assigned: group one receives the group singing intervention, group two the music listening intervention and group three as a control group (treatment as usual group) receives no musical activity.

The results of the present study should be offered to the rehabilitation centres for support of Parkinson patients.

Eligibility criteria: Inclusion Criteria:

* Adults with Parkinson's disease 1-4 according to Hoehn-Yahr Scale
* Signed consent to participate in the study
* Age \>18

Exclusion Criteria:

* Morbus Parkinson 5 according to Hoehn-Yahr Scale
* Dementia
* Aversion to music (Amusia)
* Participation in other active music-based activities (e.g. choir singing, dancing, playing an instrument, making music, playing in an orchestra) during the study

Primary outcomes:
measure: Change from Baseline Anxiety and Depression at 6 and 12 weeks
timeFrame: 18 weeks; outcomes will be measured at the beginning of the study, after 6 weeks, at the end of the study after 12 weeks, and at a follow-up 6 weeks after the end of the study
measure: Change Short-Term Neuroendocrine Stress (Hypothalamic-Pituitary-Adrenal Axis) from pre- to post music interventions over 12 weeks
timeFrame: 12 weeks; outcomes will be measured weekly immediately before and after each 45-minute session in the experimental groups. Outcomes in the control group will be measured twice every week at the same times, 45 minutes apart
measure: Change Short-Term Neuroendocrine Stress (Autonomic Nervous System) from pre- to post music interventions over 12 weeks
timeFrame: 12 weeks; outcomes will be measured weekly immediately before and after each 45-minute session in the experimental groups. Outcomes in the control group will be measured twice every week at the same times, 45 minutes apart
Secondary outcomes:
measure: Mood
timeFrame: 12 weeks; outcomes will be measured weekly immediately before and after each 45-minute session in the experimental groups. Outcomes in the control group will be measured twice every week at the same times, 45 minutes apart
measure: Stress Perception
timeFrame: 12 weeks; outcomes will be measured weekly immediately before and after each 45-minute session in the experimental groups. Outcomes in the control group will be measured twice every week at the same times, 45 minutes apart
measure: Chronic Stress
timeFrame: 18 weeks; outcomes will be measured at the beginning of the study, after 6 weeks, at the end of the study after 12 weeks, and at a follow-up 6 weeks after the end of the study
measure: Participation in meetings (compliance)
timeFrame: 12 weeks; outcomes will be measured weekly pre singing intervention
measure: Life Quality
timeFrame: 18 weeks; outcomes will be measured at the beginning of the study, after 6 weeks, at the end of the study after 12 weeks, and at a follow-up 6 weeks after the end of the study
measure: Consumption of medication
timeFrame: 18 weeks; outcomes will be measured at the beginning of the study, after 6 weeks, at the end of the study after 12 weeks, and at a follow-up 6 weeks after the end of the study
measure: Parkinson development
timeFrame: 12 weeks; outcomes will be measured at the beginning of the study and at the end of the study after 12 weeks
measure: Evaluation of the intervention
timeFrame: 12 weeks; outcomes will be measured weekly post singing and music listening sessions
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: University of Salzburg / University Mozarteum Salzburg
city: Salzburg
country: Austria
facility: University of Salzburg
Study officials:
affiliation: Focus Area Science and Art
name: Katarzyna Grebosz-Haring, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Likar R, Bernatzky G. [Improvement of pain therapy in Austria]. Schmerz. 2007 Jun;21(3):277. doi: 10.1007/s00482-007-0555-2. No abstract available. German.
citation: Bernatzky G, Bernatzky P, Hesse HP, Staffen W, Ladurner G. Stimulating music increases motor coordination in patients afflicted with Morbus Parkinson. Neurosci Lett. 2004 May 6;361(1-3):4-8. doi: 10.1016/j.neulet.2003.12.022.
citation: Grebosz-Haring K, Schuchter-Wiegand AK, Feneberg AC, Skoluda N, Nater UM, Schutz S, Thun-Hohenstein L. The Psychological and Biological Impact of "In-Person" vs. "Virtual" Choir Singing in Children and Adolescents: A Pilot Study Before and After the Acute Phase of the COVID-19 Outbreak in Austria. Front Psychol. 2022 Jan 4;12:773227. doi: 10.3389/fpsyg.2021.773227. eCollection 2021.
citation: Grebosz-Haring K, Thun-Hohenstein L. Effects of group singing versus group music listening on hospitalized children and adolescents with mental disorders: A pilot study. Heliyon. 2018 Dec 17;4(12):e01014. doi: 10.1016/j.heliyon.2018.e01014. eCollection 2018 Dec.
citation: Grebosz-Haring K, Thun-Hohenstein L, Schuchter-Wiegand AK, Irons Y, Bathke A, Phillips K, Clift S. The Need for Robust Critique of Arts and Health Research: Young People, Art Therapy and Mental Health. Front Psychol. 2022 Feb 10;13:821093. doi: 10.3389/fpsyg.2022.821093. eCollection 2022.
citation: Panksepp J, Bernatzky G. Emotional sounds and the brain: the neuro-affective foundations of musical appreciation. Behav Processes. 2002 Nov;60(2):133-155. doi: 10.1016/s0376-6357(02)00080-3.