UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062994 |
|---|---|
| Receipt number | R000072113 |
| Scientific Title | A Pilot Randomized Controlled Trial Investigating the Effects of Electronic Drum Performance on Physical and Psychological Well-Being in Healthy Adults |
| Date of disclosure of the study information | 2026/09/19 |
| Last modified on | 2026/09/19 14:38:11 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Pilot Randomized Controlled Trial on the Effects of Electronic Drum Performance on Physical and Psychological Well-Being in Healthy Adults
Acronym
ED-Wellbeing Pilot RCT
Scientific Title
A Pilot Randomized Controlled Trial Investigating the Effects of Electronic Drum Performance on Physical and Psychological Well-Being in Healthy Adults
Scientific Title:Acronym
ED-Impact Pilot RCT
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to explore the effects of active musical activity through electronic drum performance on neurophysiological, behavioral, subjective experiential, and biochemical indicators in healthy adults, using a pilot randomized controlled trial comparing an electronic drum performance group with a resting control group.
Basic objectives2
Others
Basic objectives -Others
This study is a pilot randomized controlled trial exploring the effects of electronic drum performance on neurophysiological, behavioral, subjective experiential, and biochemical indicators. Because the study does not fall under existing categories such as safety, efficacy, diagnosis, or prevention, it is classified as "Others".
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Basic objectives - Others
This study is a pilot randomized controlled trial exploring the effects of electronic drum performance on neurophysiological, behavioral, subjective experiential, and biochemical indicators. Because the study does not fall under existing categories such as safety, efficacy, diagnosis, or prevention, it is classified as "Others".
Key secondary outcomes
Secondary Endpoints
MMN and H-BAT will be analyzed using two-way repeated-measures ANOVA with group (intervention vs control) and time (pre vs post) as factors. Dependent variables are MMN amplitude and H-BAT scores (SIENT, BITper, BITpro). Main effects and interactions will be examined, and simple main effects will be analyzed when interactions are significant. The significance level will be set at 5%.
Plasma HVA will be measured only before the intervention and used as a baseline indicator reflecting individual differences in dopaminergic function. Correlation and regression analyses will be conducted to examine associations between HVA and MMN, H-BAT, and subjective experience measures.
In the intervention group, exploratory analyses will be conducted to examine associations among the following variables:
Drum-training app performance metrics (score and achievement level)
H-BAT (SIENT, BITper, BITpro)
MMN
Subjective experience measures (IMI, FSS, PANAS, FPES-S, fatigue)
HVA
These associations will be analyzed using Pearson correlation coefficients, partial correlations, and multiple regression analyses.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
Intervention group participants will perform a single session of electronic drum performance for approximately 30 minutes using an electronic drum set and a practice software application. The drum sound used in the intervention includes low frequency components in the 40 Hz gamma band.
Participants will follow the instructions of the researcher and complete the following steps.
Warm up and task explanation (approximately 3 minutes)
Participants will confirm basic movements such as stick grip, single strokes, and alternating strokes. The researcher will explain pad positions, striking methods, the display of the practice software, and how the task progresses.
Rhythm performance task (approximately 30 minutes)
Participants will perform rhythm patterns presented in the electronic drum practice software application. The task requires coordinated movements of the four limbs, focusing on bass drum, snare, and hi hat. Tempo and patterns will be selected from standard practice presets in the software and adjusted according to participant burden and skill level. The difficulty will be set so that participants can complete the task regardless of musical experience, and tasks will be presented in a stepwise manner to promote a sense of achievement.
The performance will be conducted individually, and the researcher will provide task instructions and manage progression. The sound volume will be kept at or below 85 dB for safety. If participants report fatigue or discomfort, breaks will be provided or the session will be stopped.
Interventions/Control_2
Participants in the control group will remain seated at rest in the classroom for the same duration as the intervention group (approximately 30 minutes). During the waiting period, they will read books or magazines prepared in advance, and the use of smartphones or other electronic devices will not be permitted. To minimize external stimulation, no television, music, or other audiovisual materials will be provided. The researcher will stay in the same room for safety monitoring, but communication will be kept to the minimum necessary.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.The age range was set at 18 to 59 years because the study targets adults. Individuals aged 60 years or older often show age related changes in sensory and motor functions, attentional functions, EEG responses such as MMN, and physiological indicators such as HVA. These age specific variations may influence the primary outcomes of the study. In addition, the electronic drum performance task and prolonged EEG measurement involve certain physical and cognitive demands. To ensure safety and interpretability of the data in this pilot study, a relatively homogeneous adult sample was selected and the upper age limit was set at 59 years.
2.From an ethical standpoint, only individuals who provided voluntary informed consent were included.
Key exclusion criteria
1.Individuals with a diagnosis of organic brain disorders caused by trauma or epilepsy.
2.Individuals taking medications that affect brain function, including antipsychotic drugs.
3.Individuals who have played drums at a frequency of at least once per week for six months or longer within the past three years.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Miura |
| Middle name | |
| Last name | Itaru |
Organization
Fukushima Medical University, School of Medicine
Division name
Department of Neuropsychiatry
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima City, Fukushima Prefecture
TEL
024-547-1331
c0000980@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Takahashi |
| Middle name | |
| Last name | Yuichi |
Organization
Fukushima Medical University, School of Medicine
Division name
Department of Neuropsychiatry
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima City, Fukushima Prefecture
TEL
024-547-1331
Homepage URL
c0000980@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funded
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Office, Fukushima Medical University
Address
1 Hikarigaoka, Fukushima City, Fukushima Prefecture
Tel
024-547-1331
fmurec@fmu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2029 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 19 | Day |
Last modified on
| 2026 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072113
