AzTrials
AzTrials

ParkinsonCHORMORPARKNCT05379062

Choral Singing for Patients With Parkinson's

A study testing Active Singing Group and Receptive Music Group in people with Parkinson, run by University of Salzburg at 2 sites in Austria.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parkinson
What is being tested?
Active Singing Group and Receptive Music Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
2 sitesAustria
Study dates
May 2022to Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

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

Austria2 sites

  • University of Salzburg / University Mozarteum Salzburg

    Salzburg, 5020

    Katarzyna Grebosz-Haring, Dr., +4366280442370 ext. +4366280442370, katarzyna.grebosz-haring@plus.ac.at

  • University of Salzburg

    Salzburg, 5020

    Günther Bernatzky, +436644421237 ext. +436644421237, guenther.bernatzky@plus.ac.at

Other trials in Austria

About this study

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 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);

Read more

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).

Read the 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.

Conditions
Parkinson
Being tested
Active Singing Group, Receptive Music Group
Keywords
Parkinson, Singing, Music, Stress, Cortisol, Depression
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active Singing GroupBehavioural

    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.

  • Receptive Music GroupBehavioural

    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.

Study groups in NCT05379062
Study groupRoleWhat they receive
Active Singing GroupExperimentalActive singing in a group
Receives: Behavioral: Active Singing Group
Receptive Music GroupExperimentalReceptive music/auditive group
Receives: Behavioral: Receptive Music Group
Control GroupNo interventionTreatment as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 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

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

    Biological Stress Marker: Salivary Cortisol

    Measured: 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

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

    Biological Stress Marker: Salivary Alpha-Amylase

    Measured: 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)

  1. Mood

    Multidimensional Mood State Questionnaire, short version (1997), R. Steyer, P. Notz, P. Schwenkmezger \& M. Eid. Higher score means a better outcome

    Measured: 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

  2. Stress Perception

    Visual Analogue Scale. Minimum 0, Maximum 100, higher score means a worse outcome

    Measured: 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

  3. Chronic Stress

    Perceived Stress Scale German version (2020), E.E. Schneider, S. Schönfelder, M. Domke-Wolf \& M. Wessa. Higher score means a worse outcome

    Measured: 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

  4. Participation in meetings (compliance)

    Self-developed compliance sheet for patients. Minimum 0, maximum 12. Higher score means a better outcome

    Measured: 12 weeks; outcomes will be measured weekly pre singing intervention

  5. Life Quality

    Parkinson's Disease Questionnaire German Version (2011), S. Schädler. Minimum 0, maximum 100, higher score means a worse outcome

    Measured: 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

  6. Consumption of medication

    Sheet for patients, higher score means a worse outcome

    Measured: 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

  7. 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

    Measured: 12 weeks; outcomes will be measured at the beginning of the study and at the end of the study after 12 weeks

  8. 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)

    Measured: 12 weeks; outcomes will be measured weekly post singing and music listening sessions

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2022
  2. Study startMay 2022 (estimated)
  3. Primary completionOct 2022 (estimated)
  4. Study completionSep 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
Experimental group (singing in a group/active) Experimental group (receptive music/auditive) Control group (treatment as usual condition)
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05379062
Sponsor's protocol ID
1_1: 2020-06-08
Acronym
CHORMORPARK
Status last verified
May 2022
First submitted
25 Apr 2022
Last updated
25 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 17632876

  • 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.

    PubMed 15135879

  • 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.

    PubMed 35058843

  • 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.

    PubMed 30582039

  • 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.

    PubMed 35222203

  • 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.

    PubMed 12426066

Questions about this trial

What is this clinical trial studying?

A study testing Active Singing Group and Receptive Music Group in people with Parkinson, run by University of Salzburg at 2 sites in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Katarzyna Grebosz-Haring, Dr. (+4380442370, katarzyna.grebosz-haring@plus.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline Anxiety and Depression at 6 and 12 weeks (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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05379062, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in