Choral Singing for Patients With Parkinson's

NCT05379062 | Unknown

• 1 other identifier: 1_1: 2020-06-08
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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).

Conditions

Parkinson

Keywords

Parkinson; Singing; Music; Stress; Cortisol; Depression

Outcome Measures

Primary Outcomes (3)

• 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

  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

• Change Short-Term Neuroendocrine Stress (Hypothalamic-Pituitary-Adrenal Axis) from pre- to post music interventions over 12 weeks

  Biological Stress Marker: Salivary Cortisol

  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

• Change Short-Term Neuroendocrine Stress (Autonomic Nervous System) from pre- to post music interventions over 12 weeks

  Biological Stress Marker: Salivary Alpha-Amylase

  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 (8)

• Mood

  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

• Stress Perception

  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

• Chronic Stress

  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

• Participation in meetings (compliance)

  12 weeks; outcomes will be measured weekly pre singing intervention

• Life Quality

  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

Study Arms (3)

Active Singing Group

EXPERIMENTAL

Active singing in a group

Behavioral: Active Singing Group

Receptive Music Group

EXPERIMENTAL

Receptive music/auditive group

Behavioral: Receptive Music Group

Control Group

NO INTERVENTION

Treatment as usual

Interventions

Active Singing Group BEHAVIORAL

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.

Active Singing Group

Receptive Music Group BEHAVIORAL

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.

Receptive Music Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Salzburg: lead
• University of Vienna: collaborator
• Confraternität Private Hospital: collaborator

Study Sites (2)

University of Salzburg / University Mozarteum Salzburg

Salzburg, 5020, Austria

Location

University of Salzburg

Salzburg, 5020, Austria

Location

Related Publications (6)

• 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.

  PMID: 17632876 BACKGROUND

• 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.

  PMID: 15135879 RESULT

• 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.

  PMID: 35058843 RESULT

• 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.

  PMID: 30582039 RESULT

• 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.

  PMID: 35222203 RESULT

• 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.

  PMID: 12426066 RESULT

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Katarzyna Grebosz-Haring, Dr.

  Focus Area Science and Art

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katarzyna Grebosz-Haring, Dr.

CONTACT

+4380442370; katarzyna.grebosz-haring@plus.ac.at

Günther Bernatzky, Univ. Prof.

CONTACT

+43 664 44-21237; guenther.bernatzky@plus.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Experimental group (singing in a group/active) Experimental group (receptive music/auditive) Control group (treatment as usual condition)

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: May 18, 2022
• Study Start: May 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: September 1, 2023
• Last Updated: May 25, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)