A study on stress reduction effects of combined vibration and music stimulation
| ISRCTN | ISRCTN10662834 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10662834 |
| Secondary identifying numbers | UMIN000058197 |
- Submission date
- 30/07/2025
- Registration date
- 08/08/2025
- Last edited
- 08/08/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Stress is a growing health concern. This study aims to explore whether a simple form of vibration stimulation, synchronized with music and the participant's heart rate, can help people recover from acute stress more effectively.
Who can participate?
Healthy male adults aged between 25 and 49 years.
What does the study involve?
The study consists of two parts.
In the first part, participants receive one of three conditions: (1) vibration that gradually slows down, (2) fixed-rate vibration, or (3) no vibration.
In the second part, each participant experiences all three conditions in random order: (1) vibration plus synchronized music, (2) music only, and (3) no stimulation.
Stress levels are measured before and after each condition.
What are the possible benefits and risks of participating?
There is no direct benefit to the participants. Risks are minimal, as the vibration and music are non-invasive and commonly used in relaxation settings.
Where is the study run from?
The study is conducted at the Frontier Research Center of POLA Chemical Industries Inc. in Yokohama, Japan.
When is the study starting and how long is it expected to run for?
June 2020 to April 2021
Who is funding the study?
POLA Chemical Industries Inc. (Japan)
Who is the main contact?
Dr Tomonori Motokawa, motchy.motchy@mail.u-tokyo.ac.jp
Contact information
Public
560 Kashio-cho
Totsuka-ku
Yokohama
244-0812
Japan
| Phone | +81 (0)45 826 7134 |
|---|---|
| k-tomo@pola.co.jp |
Scientific, Principal Investigator
560 Kashio-cho
Totsuka-ku
Yokohama
244-0812
Japan
| Phone | +81 (0)45 826 7134 |
|---|---|
| motchy.motchy@mail.u-tokyo.ac.jp |
Study information
| Study design | Randomized crossover open-label placebo-controlled single-centre interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Pre-post study with physiological and subjective outcomes |
| Study setting(s) | Internet/virtual, Laboratory |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | A confirmatory randomized crossover trial to evaluate the effects of gradually slowing tempo vibration and music stimulation on acute stress recovery in healthy male adults |
| Study objectives | 1. To evaluate whether gradually slowing tempo synchronized vibration and music stimulation reduce acute stress in healthy adults. 2. To compare the stress-relieving effects of combined vibration and music stimulation, music only, and no intervention. |
| Ethics approval(s) |
1. Approved 29/10/2020, Committee for the Protection of Human Subjects, POLA Chemical Industries Inc. (560 Kashio-cho, Totsuka-ku, Yokohama, 244-0812, Japan; +81 (0)45 826 7134; y-miyasaka@pola.co.jp), ref: 2020-F-132 2. Approved 07/04/2021, Committee for the Protection of Human Subjects, POLA Chemical Industries Inc. (560 Kashio-cho, Totsuka-ku, Yokohama, 244-0812, Japan; +81 (0)45 826 7134; y-miyasaka@pola.co.jp), ref: 2021-F-022 |
| Health condition(s) or problem(s) studied | Psychological stress, mental fatigue |
| Intervention | This study included two phases: Phase 1 (Parallel design, n = 42): Participants were randomly allocated to one of the following three arms: 1. Variable vibration: Participants held a handheld vibration device for 2 minutes. Vibration tempo was synchronized with their resting heart rate and gradually decreased to 50 bpm. 2. Fixed vibration: Participants received 2 minutes of vibration at a fixed tempo (50 bpm or half the heart rate). 3. Control: Participants held the same device without vibration. Phase 2 (Crossover design, n = 36): Each participant experienced all three conditions in a randomized order: 1. Vibration + music: Participants received synchronized vibration and music with tempo gradually slowing from 75 to 50 bpm over 3.5 minutes. 2. Music only: Participants listened to the same music without vibration. 3. Control: No music or vibration; participants held the device and wore headphones. In both phases of the study, participants were randomly assigned to each condition using a computer-generated randomisation list prepared in advance. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Custom-designed handheld vibration device and original synchronized ambient music |
| Primary outcome measure | Subjective stress level measured using the Visual Analogue Scale (VAS) at three timepoints: baseline (before mental load), immediately after mental load (stressed), and after intervention (post-intervention) |
| Secondary outcome measures | 1. Salivary cortisol levels measured using enzyme immunoassay at baseline, after mental load, and post-intervention 2. Emotional state and mood measured using the Emotion and Mood Inventory (EMI) at baseline and post-intervention 3. Subjective fatigue level measured using the Jikaku-sho Shirabe fatigue questionnaire at baseline and post-intervention 4. Tense Arousal (TA) and Energetic Arousal (EA) derived from an 8-item subjective stress scale assessed at baseline and post-intervention |
| Overall study start date | 01/06/2020 |
| Completion date | 25/04/2021 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 25 Years |
| Upper age limit | 49 Years |
| Sex | Male |
| Target number of participants | 78 |
| Total final enrolment | 78 |
| Key inclusion criteria | 1. Healthy males 2. Aged between 25 and 49 years 3. Provided written informed consent after receiving sufficient explanation of the study |
| Key exclusion criteria | 1. History of cardiovascular or severe physical illness 2. Use of medications that affect the autonomic nervous system 3. Hearing difficulties or discomfort with headphones 4. Inability to maintain regular lifestyle during study period 5. Use of cardiac pacemaker 6. Determined unsuitable for participation by the principal investigator |
| Date of first enrolment | 31/10/2020 |
| Date of final enrolment | 17/04/2021 |
Locations
Countries of recruitment
- Japan
Study participating centre
Totsuka-ku
Yokohama
244-0812
Japan
Sponsor information
Industry
560 Kashio-cho
Totsuka-ku
Yokohama
244-0812
Japan
| Phone | +81 (0)45 826 7134 |
|---|---|
| rm-webmaster@pola.co.jp | |
| Website | https://www.pola-rm.co.jp/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 30/06/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Results will be submitted for publication in a peer-reviewed journal (e.g., BMC Psychology). |
| IPD sharing plan | Individual participant data will not be shared publicly due to privacy protection and informed consent limitations. |
Editorial Notes
07/08/2025: Study's existence confirmed by by the ethics committee of POLA Chemical Industries Inc.
