CHORMORPARK: Choral Singing for Patients With Parkinson's

Sponsor
University of Salzburg (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05379062
Collaborator
University of Vienna (Other), Confraternität Private Hospital (Other)
90
2
3
16
45
2.8

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Active Singing Group
  • Behavioral: Receptive Music Group
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Experimental group (singing in a group/active) Experimental group (receptive music/auditive) Control group (treatment as usual condition)Experimental group (singing in a group/active) Experimental group (receptive music/auditive) Control group (treatment as usual condition)
Masking:
None (Open Label)
Primary Purpose:
Basic Science
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
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Active Singing Group

Active singing in a group

Behavioral: Active Singing Group
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.

Experimental: Receptive Music Group

Receptive music/auditive group

Behavioral: Receptive Music Group
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.

No Intervention: Control Group

Treatment as usual

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline Anxiety and Depression at 6 and 12 weeks [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]

    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

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

    Biological Stress Marker: Salivary Cortisol

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

    Biological Stress Marker: Salivary Alpha-Amylase

Secondary Outcome Measures

  1. 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]

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

  2. 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]

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

  3. 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]

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

  4. Participation in meetings (compliance) [12 weeks; outcomes will be measured weekly pre singing intervention]

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

  5. 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]

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

  6. Consumption of medication [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]

    Sheet for patients, higher score means a worse outcome

  7. Parkinson development [12 weeks; outcomes will be measured at the beginning of the study and at the end of the study after 12 weeks]

    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

  8. Evaluation of the intervention [12 weeks; outcomes will be measured weekly post singing and music listening sessions]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Salzburg / University Mozarteum Salzburg Salzburg Austria 5020
2 University of Salzburg Salzburg Austria 5020

Sponsors and Collaborators

  • University of Salzburg
  • University of Vienna
  • Confraternität Private Hospital

Investigators

  • Principal Investigator: Katarzyna Grebosz-Haring, Dr., Focus Area Science and Art

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Katarzyna Grebosz-Haring, Principal Investigator, University of Salzburg
ClinicalTrials.gov Identifier:
NCT05379062
Other Study ID Numbers:
  • 1_1: 2020-06-08
First Posted:
May 18, 2022
Last Update Posted:
May 25, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Katarzyna Grebosz-Haring, Principal Investigator, University of Salzburg
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 25, 2022