Tokyo, Sept. 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062994) titled 'A Pilot Randomized Controlled Trial on the Effects of Electronic Drum Performance on Physical and Psychological Well-Being in Healthy Adults' on Sept. 19.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Fukushima Medical University, School of Medicine

Condition: Condition - Healthy Adults Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

Eligibility: Age-lower limit - 18 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 Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 06 Month 09 Day Anticipated trial start date - 2026 Year 09 Month 28 Day Last follow-up date - 2029 Year 05 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072113

Disclaimer: Curated by HT Syndication.