Beneficial effects of music therapy on stress reduction
| ISRCTN | ISRCTN70947363 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70947363 |
- Submission date
- 04/10/2020
- Registration date
- 11/10/2020
- Last edited
- 12/10/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
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 12-minute period of listening to music with either conventional headphones (CH; “MEZE 99 Classic”) or with the same – but internally modified – headphone (called “Lautsaenger”).
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 September 2022
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Anna Hohneck
annalena.hohneck@umm.de
Contact information
Scientific
First Department of Medicine – Cardiology
University Medical Center Mannheim, Heidelberg University
Theodor-Kutzer-Ufer 1-3
Mannheim
68167
Germany
 ORCID ID |
0000-0002-7629-2770 |
|---|---|
| Phone | +49 (0)17670738117 |
| annalena.hohneck@umm.de |
Study information
| Study design | Interventional randomized parallel trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital, University/medical school/dental school |
| Study type | Quality of life |
| Participant information sheet | ISRCTN70947363_PIS_v1.1_30Sept2019.pdf |
| Scientific title | Beneficial effects of a sound intervention in the form of music therapy on stress reduction |
| 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(s) | 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 |
| Condition | Increased stress level |
| Intervention | Current interventions as of 15/05/2023: Participants are randomized to a 12-minute sound intervention (classical music) with either conventional headphones (CH; “MEZE 99 Classic”) or with the same – but internally modified – headphone (called “Lautsaenger”). _____ Previous interventions: 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 |
| 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 | Current secondary outcome measures as of 15/05/2023: 1. Numeric rating scale (NRS) for emotions and stress before and after sound intervention (emotional well-being, pain, anger, anxiety, sadness, stress, music for coping stress). 2. The modified Maslach Burnout Inventory (MBI) to assess the burnout risk before and after sound intervention. 3. NRS for subjective sound perception and to what extent listening stimulated the imagination was fulfilled after sound intervention. In addition, dichotomous questions were used to evaluate the headphone systems in particular. _____ Previous 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 study start date | 01/05/2019 |
| Overall study end date | 01/09/2022 |
Eligibility
| Participant type(s) | Healthy volunteer, Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 100 |
| Participant inclusion criteria | 1. Age ≥18 years 2. Written informed consent |
| 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 | 01/07/2020 |
| Recruitment end date | 01/09/2020 |
Locations
Countries of recruitment
- Germany
Study participating centre
Interdisciplinary Tumor Center Mannheim (ITM)
Medical Faculty Mannheim
Theodor-Kutzer-Ufer 1-3
Mannheim
68167
Germany
Sponsor information
University/education
Theodor-Kutzer-Ufer 1-3
Mannheim
68167
Germany
| Phone | +49 6213832204 |
|---|---|
| med1@umm.de | |
| Website | https://www.umm.de/i-medizinische-klinik/forschung-lehre/studienzentrum/ |
"ROR" |
https://ror.org/05sxbyd35 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/04/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal (Integrative Cancer Therapies) |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version v1.1 | 30/09/2019 | 05/11/2020 | No | Yes |
| Protocol file | 05/11/2020 | No | No | ||
| Results article | 01/01/2021 | 13/08/2021 | Yes | No | |
| Results article | 11/10/2023 | 12/10/2023 | Yes | No |
Additional files
- ISRCTN70947363_PIS_v1.1_30Sept2019.pdf
- uploaded 05/11/2020
- ISRCTN70947363_PROTOCOL.pdf
- uploaded 05/11/2020
Editorial Notes
12/10/2023: Publication reference added.
15/05/2023: The following changes were made to the trial record:
1. The study design was changed from "Interventional randomized crossover trial" to "Interventional randomized parallel trial".
2. The study setting University/medical school/dental school was added.
3. The overall end date was changed from 01/08/2020 to 01/09/2022.
4. The interventions were changed.
5. The secondary outcome measures were changed.
6. The participant type Healthy volunteer was added.
7. The target number of participants was changed from 150 to 100.
8. The total final enrolment was changed from 52 to 100.
9. The recruitment start date was changed from 08/11/2019 to 01/07/2020.
10. The recruitment end date was changed from 24/04/2020 to 01/09/2020.
11. The intention to publish date was changed from 01/11/2020 to 01/04/2023.
12. The plain English summary was updated to reflect these changes.
13/08/2021: Internal review.
06/04/2021: Publication reference added.
05/11/2020: Uploaded protocol (not peer reviewed). Uploaded participant information sheet.
06/10/2020: Trial's existence confirmed by Medical Ethics Commission II, Faculty of Medicine Mannheim.
