Choral Singing for Patients With Parkinson's (CHORMORPARK)
Primary Purpose
Parkinson
Status
Not yet recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Active Singing Group
Receptive Music Group
Sponsored by
About this trial
This is an interventional basic science trial for Parkinson focused on measuring Parkinson, Singing, Music, Stress, Cortisol, Depression
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
Sites / Locations
- University of Salzburg / University Mozarteum Salzburg
- University of Salzburg
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Active Singing Group
Receptive Music Group
Control Group
Arm Description
Active singing in a group
Receptive music/auditive group
Treatment as usual
Outcomes
Primary Outcome Measures
Change from Baseline Anxiety and Depression at 6 and 12 weeks
Hospital Anxiety and Depression Scale - German Version 2011, C. Herrmann-Lingen, U. Buss & R. P. Snaith. Minimum value 0, maximum value 21, higher score means a better outcome
Change Short-Term Neuroendocrine Stress (Hypothalamic-Pituitary-Adrenal Axis) from pre- to post music interventions over 12 weeks
Biological Stress Marker: Salivary Cortisol
Change Short-Term Neuroendocrine Stress (Autonomic Nervous System) from pre- to post music interventions over 12 weeks
Biological Stress Marker: Salivary Alpha-Amylase
Secondary Outcome Measures
Mood
Multidimensional Mood State Questionnaire, short version (1997), R. Steyer, P. Notz, P. Schwenkmezger & M. Eid. Higher score means a better outcome
Stress Perception
Visual Analogue Scale. Minimum 0, Maximum 100, higher score means a worse outcome
Chronic Stress
Perceived Stress Scale German version (2020), E.E. Schneider, S. Schönfelder, M. Domke-Wolf & M. Wessa. Higher score means a worse outcome
Participation in meetings (compliance)
Self-developed compliance sheet for patients. Minimum 0, maximum 12. Higher score means a better outcome
Life Quality
Parkinson's Disease Questionnaire German Version (2011), S. Schädler. Minimum 0, maximum 100, higher score means a worse outcome
Consumption of medication
Sheet for patients, higher score means a worse outcome
Parkinson development
Hoehn-Yahr scale (1967), M. M. Hoehn & M. D. Yahr (evaluation by the neurologist). Minimum value 1, maximum value 5, higher score means a worse outcome
Evaluation of the intervention
Liking of the session, liking of the songs/music pieces, familiarity with the songs/music pieces (9-point Likert scale; higher score means a better outcome)
Full Information
NCT ID
NCT05379062
First Posted
April 25, 2022
Last Updated
May 18, 2022
Sponsor
University of Salzburg
Collaborators
University of Vienna, Confraternität Private Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05379062
Brief Title
Choral Singing for Patients With Parkinson's
Acronym
CHORMORPARK
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
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2022 (Anticipated)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Salzburg
Collaborators
University of Vienna, Confraternität Private Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson
Keywords
Parkinson, Singing, Music, Stress, Cortisol, Depression
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental group (singing in a group/active) Experimental group (receptive music/auditive) Control group (treatment as usual condition)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active Singing Group
Arm Type
Experimental
Arm Description
Active singing in a group
Arm Title
Receptive Music Group
Arm Type
Experimental
Arm Description
Receptive music/auditive group
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
Active Singing Group
Intervention Description
The participants of the Active Singing Group take part in a weekly 45-minute singing activity in a group over a period of 3 months. In total the investigators expect 12 choir rehearsals. The rehearsals will take place between 2pm and 3.30pm in the church of the Wehrle-Diakonissen Private Clinic in Salzburg. The group will be led by a professional and experienced choir director.
Intervention Type
Behavioral
Intervention Name(s)
Receptive Music Group
Intervention Description
The participants of the Receptive Music Group will individually listen to the already researched CD for Parkinson's patients (Bernatzky, Wendtner, Volc, 2012) at home at the same time on one weekday.
Primary Outcome Measure Information:
Title
Change from Baseline Anxiety and Depression at 6 and 12 weeks
Description
Hospital Anxiety and Depression Scale - German Version 2011, C. Herrmann-Lingen, U. Buss & R. P. Snaith. Minimum value 0, maximum value 21, higher score means a better outcome
Time Frame
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
Title
Change Short-Term Neuroendocrine Stress (Hypothalamic-Pituitary-Adrenal Axis) from pre- to post music interventions over 12 weeks
Description
Biological Stress Marker: Salivary Cortisol
Time Frame
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
Title
Change Short-Term Neuroendocrine Stress (Autonomic Nervous System) from pre- to post music interventions over 12 weeks
Description
Biological Stress Marker: Salivary Alpha-Amylase
Time Frame
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 Outcome Measure Information:
Title
Mood
Description
Multidimensional Mood State Questionnaire, short version (1997), R. Steyer, P. Notz, P. Schwenkmezger & M. Eid. Higher score means a better outcome
Time Frame
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
Title
Stress Perception
Description
Visual Analogue Scale. Minimum 0, Maximum 100, higher score means a worse outcome
Time Frame
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
Title
Chronic Stress
Description
Perceived Stress Scale German version (2020), E.E. Schneider, S. Schönfelder, M. Domke-Wolf & M. Wessa. Higher score means a worse outcome
Time Frame
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
Title
Participation in meetings (compliance)
Description
Self-developed compliance sheet for patients. Minimum 0, maximum 12. Higher score means a better outcome
Time Frame
12 weeks; outcomes will be measured weekly pre singing intervention
Title
Life Quality
Description
Parkinson's Disease Questionnaire German Version (2011), S. Schädler. Minimum 0, maximum 100, higher score means a worse outcome
Time Frame
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
Title
Consumption of medication
Description
Sheet for patients, higher score means a worse outcome
Time Frame
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
Title
Parkinson development
Description
Hoehn-Yahr scale (1967), M. M. Hoehn & M. D. Yahr (evaluation by the neurologist). Minimum value 1, maximum value 5, higher score means a worse outcome
Time Frame
12 weeks; outcomes will be measured at the beginning of the study and at the end of the study after 12 weeks
Title
Evaluation of the intervention
Description
Liking of the session, liking of the songs/music pieces, familiarity with the songs/music pieces (9-point Likert scale; higher score means a better outcome)
Time Frame
12 weeks; outcomes will be measured weekly post singing and music listening sessions
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katarzyna Grebosz-Haring, Dr.
Phone
+4380442370
Email
katarzyna.grebosz-haring@plus.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Günther Bernatzky, Univ. Prof.
Phone
+43 664 44-21237
Email
guenther.bernatzky@plus.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katarzyna Grebosz-Haring, Dr.
Organizational Affiliation
Focus Area Science and Art
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Salzburg / University Mozarteum Salzburg
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katarzyna Grebosz-Haring, Dr.
Phone
+4366280442370
Ext
+4366280442370
Email
katarzyna.grebosz-haring@plus.ac.at
Facility Name
University of Salzburg
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Günther Bernatzky
Phone
+436644421237
Ext
+436644421237
Email
guenther.bernatzky@plus.ac.at
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
17632876
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.
Results Reference
background
PubMed Identifier
15135879
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.
Results Reference
result
PubMed Identifier
35058843
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.
Results Reference
result
PubMed Identifier
30582039
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.
Results Reference
result
PubMed Identifier
35222203
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.
Results Reference
result
PubMed Identifier
12426066
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.
Results Reference
result
Learn more about this trial
Choral Singing for Patients With Parkinson's
We'll reach out to this number within 24 hrs