Condition category
Mental and Behavioural Disorders
Date applied
04/10/2020
Date assigned
11/10/2020
Last edited
07/10/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Music therapy or sound interventions have been shown to benefit patients in terms of pain or fear relief and improvement of other patient-reported outcomes. The effect of stress on the heart, particularly the variation in heart rate, is known to indicate that more serious problems can occur later. The aim of this study is to investigate the effects of a sound intervention on heart rate.

Who can participate?
Patients who are exposed to increased stress levels due to their illness, as well as formally healthy people, can participate in the study.

What does the study involve?
The planned study project will investigate the effects of music therapy in patients and healthy individuals with an increased stress level, in particular with regard to a possible positive effect on the autonomic nervous system in terms of stress reduction. In order to take into account a possible positive effect of music intervention, a music intervention will therefore be compared to rest. Participants will have their heart rate measured before and after a 15 period of either rest or listening to music. On another day they will do the opposite (music or rest) and measurements will be taken in a similar manner.

What are the possible benefits and risks of participating?
There are no known disadvantages for the participants in the study. There are no known harmful effects of music therapy. As music therapy is a recognised, established procedure whose effectiveness has already been proven in meta-analyses, the researchers hope to achieve a positive effect from which every participant in the study will benefit directly.

Where is the study run from?
University Medical Centre Mannheim (Germany)

When is the study starting and how long is it expected to run for?
May 2019 to August 2020

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Anna Hohneck
annalena.hohneck@umm.de

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anna Hohneck

ORCID ID

https://orcid.org/0000-0002-7629-2770

Contact details

First Department of Medicine – Cardiology
University Medical Center Mannheim
Heidelberg University
Theodor-Kutzer-Ufer 1-3
Mannheim
68167
Germany
+49 (0)17670738117
annalena.hohneck@umm.de

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Beneficial effects of a sound intervention in the form of music therapy on stress reduction

Acronym

Study hypothesis

Music therapy is a recognised medical procedure that uses music to address physical, emotional, cognitive and social disorders. The interventions used include playing instruments, vocal and instrumental improvisation, singing, composition/songwriting, music guided imagination techniques and listening to music.
Music therapy is said to have a positive effect on well-being, stress management, pain relief, emotional expression, memory, communication skills and physical rehabilitation.
There is some evidence that music therapy can be a useful supportive measure in the treatment of chronically ill patients. Results of recent systematic reviews suggest that music interventions have moderate to strong treatment effects on the parameters of anxiety, depression, fatigue, pain and quality of life in chronically ill patients. In addition, a slight improvement in vital parameters such as heart rate, blood pressure and respiratory rate has been described, which indicate a reduction in stress. This study will therefore examine the effects of music therapy in patients exposed to higher stress levels, especially with regard to a possible positive effect on the autonomic nervous system in terms of stress reduction.

Ethics approval

Approved 08/11/2019, Local ethical committee, Medical Ethics Commission II, Faculty of Medicine Mannheim (University of Heidelberg, Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany; +49 (0)621 383 71770; ethikkommission-II@medma-uni-heidelberg.de), ref: 2019-736N

Study design

Interventional randomized crossover trial

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Increased stress level

Intervention

All participants receive both a 15-minute sound intervention and a 15-minute rest intervention on separate days as part of a cross-over design.

The order of interventions is randomly decided using sealed envelopes.

The sound intervention was performed with an instrument called "Heaven and Earth" (http://klangkoerper.de/himmel-und-erde.html). This instrument consists of a semi-open resonance body with 29 strings (24 of those in C1sharp, two in C2sharp, two C3sharp, and one in G3sharp). The monochord is placed on the chest during the intervention to ensure optimal transmission of the vibrations.

The rest intervention is done in a lying position for 15 minutes after the 10-minute resting phase.

The gap between the two intervention days is a maximum of 4 weeks.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Cardiovascular parameters (heart rate, blood pressure, heart rate variability and pulse wave velocity) assessed non-invasively using the VascAssist 2 device at baseline and after the rest and sound interventions

Secondary outcome measures

Quality of life assessed using the health-related quality of life (HRQOL) questionnaire at baseline and after the rest and sound interventions

Overall trial start date

01/05/2019

Overall trial end date

01/08/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Age ≥ 18 years
2. Written informed consent

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

150

Total final enrolment

52

Participant exclusion criteria

1. Acute myocardial infarction or stroke (within the past 30 days)
2. Cardiogenic shock
3. Indication for an aortocoronary bypass operation
4. Known minimal heart rate at rest below 50 bpm
5. Need for pacemaker stimulation
6. Hypotension with systolic blood pressure <80 mmHg or uncontrolled hypertension with systolic blood pressure ≥180 mmHg, bilateral axilla dissection
7. Parkinson’s disease or tremor of other origin
8. Atrial fibrillation

Recruitment start date

08/11/2019

Recruitment end date

24/04/2020

Locations

Countries of recruitment

Germany

Trial participating centre

Heidelberg University
Third Department of Medicine (Hematology and Oncology) Interdisciplinary Tumor Center Mannheim (ITM) Medical Faculty Mannheim Theodor-Kutzer-Ufer 1-3
Mannheim
68167
Germany

Sponsor information

Organisation

University Medical Centre Mannheim

Sponsor details

Theodor-Kutzer-Ufer 1-3
Mannheim
68167
Germany
+49 6213832204
med1@umm.de

Sponsor type

University/education

Website

https://www.umm.de/i-medizinische-klinik/forschung-lehre/studienzentrum/

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal (Integrative Cancer Therapies)

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from the corresponding author Dr Anna Hohneck (annalenahohneck@umm.de). The data will be provided as anonymized data (Excel file), upon request from scientific stuff (after verification). The data transfer will take place via secure transfer services to guarantee security. The transmission of raw data will only take place after prior consultation with the participants and their corresponding consent. The data is provided only for transparency purposes only and not for further analysis.

Intention to publish date

01/11/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

06/10/2020: Trial's existence confirmed by Medical Ethics Commission II, Faculty of Medicine Mannheim.