UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051743 |
|---|---|
| Receipt number | R000059055 |
| Scientific Title | Comparative study of the effects of silence, environmental sounds, and music on autonomic nervous system activity and short-term memory in the same subjects. |
| Date of disclosure of the study information | 2023/07/28 |
| Last modified on | 2025/02/10 12:54:16 |
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Basic information
Public title
Effects of different sounds on autonomic nervous system changes and learning effects
Acronym
Effects of sounds on the autonomic nervous system and learning outcomes
Scientific Title
Comparative study of the effects of silence, environmental sounds, and music on autonomic nervous system activity and short-term memory in the same subjects.
Scientific Title:Acronym
Comparative study of sound, autonomic nervous system activity, and short-term memory
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effects of silence, environmental sounds, and music on learning, especially short-term memory, and on the autonomic nervous system, we will measure heart rate, blood pressure, and cardiac sympathetic and parasympathetic nervous system activity during learning in undergraduate and graduate students. Subjective measures such as the subject's concentration and ease of engagement with silence, environmental sounds, and music will be measured. By comparing the results of each of these measures, we aim to clarify the degree of autonomic nervous system activity during learning, and by comparing their effects on learning effectiveness, we hope to develop an individualized learning environment, including a desirable way to incorporate sound tailored to each learner. By comparing the results of each, the degree of autonomic nervous system activity during learning will be clarified, and the effects on learning effectiveness will be compared. The purpose of this study is to develop an individualized learning environment, including a desirable way of incorporating sound tailored to the learner.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A heart rate variability real-time analyzer (MemCalc/Bonaly Light: GMS) is attached to the subject. After 5 minutes of measurement in a resting sitting position, 5 minutes of word memory, followed by 5 minutes of rest, the test is performed for 10 minutes, during which time autonomic nerve activity is measured. In the heart rate variability analysis, the Low Frequency (LF, low frequency, and High Frequency (HF, high frequency, 0.15-0.40 Hz band) components are extracted as changes in autonomic activity, the HF component is cardiac vagal activity, and the ratio of both components (LF/HF) is an index of cardiac sympathetic nerve activity. These measures are compared with the results of the VAS scale responses in the questionnaire and the performance in the post-memorization exam to examine the relevance of these measures.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Three interventions are administered to 30 identical subjects: silence, environmental sound, and music during resting, memorization, and rest periods (15 minutes total).
Silence (control) will be administered the first time, and environmental sound and music are administered on separate days.
The order of the environmental sound and music interventions is randomly assigned so that there are an equal number of subjects.
Intervention 1: Silence / (another day) / environmental sounds / (another day) / music
Interventions/Control_2
Intervention 2: Silence / (another day) / music / (another day) / environmental sounds
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
| 20 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) 20 to 30 years old, 15 males and 15 females
2) Persons belonging to the Department of Health Sciences, Gunma University School of Medicine, or the Graduate School of Health Sciences, Gunma University
3) Healthy subjects with no disease currently under treatment
4) Persons who can give written consent to participate in this study.
Key exclusion criteria
1) Those who have symptoms of auditory hypersensitivity, such as hypersensitivity to certain sounds or anxiety.
2) Persons with a history of the following: persons who have been diagnosed with hearing impairment, such as inability to hear sounds or difficulty in hearing
3) Persons who are deemed inappropriate by the responsible person.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Yokoyama |
Organization
Gunma University Graduate School of Health Sciences
Division name
Department of Laboratory Sciences
Zip code
371-8511
Address
3-39-22 Showa-machi, Maebashi, Gunma
TEL
+81-27-220-7111
tyokoyama@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Matsui |
Organization
Gunma University Graduate School of Health Sciences
Division name
Department of Laboratory Sciences
Zip code
371-8511
Address
3-39-22 Showa-machi, Maebashi, Gunma
TEL
+81-27-220-8973
Homepage URL
hmatsui@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma University
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Ethical Review Board for Medical Research Involving Human Subjects
Address
3-39-22 Showa-machi, Maebashi, Gunma
Tel
027-220-7111
hitotaisho-ciru@ml.gunma-u.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
| 2023 | Year | 07 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 11 | Month | 10 | Day |
Date trial data considered complete
| 2025 | Year | 11 | Month | 10 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 28 | Day |
Last modified on
| 2025 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059055
