UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061202 |
|---|---|
| Receipt number | R000068828 |
| Scientific Title | A Single-Arm Pre-Post study on the Effects of Vocal Music Education on Socio-psycho-microbiological indices of Young Women |
| Date of disclosure of the study information | 2026/04/08 |
| Last modified on | 2026/04/08 19:17:46 |
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Basic information
Public title
Study on the Effects of Vocal Music Education on the Mental Well-being of Women's University Students
Acronym
Vocal Health Study
Scientific Title
A Single-Arm Pre-Post study on the Effects of Vocal Music Education on Socio-psycho-microbiological indices of Young Women
Scientific Title:Acronym
VOR Study
Region
| Japan |
Condition
Condition
Not applicable (educational intervention study on healthy female university students)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the effects of vocal music education, including vocal training, and choral singing, on social resilience, and psychological well-being in young women, in relation to changes in dietary quality, and gut environment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in social resilience and psychological indicators (loneliness and depressive tendencies) before and after the vocal music education intervention.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
An educational intervention based on vocal music education will be conducted. The intervention consists primarily of vocal training, and choral singing in 15 sessions (approximately 3.5 months). The program includes training of proper vocalization, training of breathing, and cooperative choral activities supplemented by video-based self-practice and peer feedback.
Interventions/Control_2
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
| 25 | years-old | > |
Gender
Female
Key inclusion criteria
1.Female university students of 18 to 25 year old
2.Individuals who understood the aim of this study and signed informed consent
3.Individuals who are able to continuously participate in vocal music education (vocal training and choral singing)
Key exclusion criteria
1.Students of department of music
2.Individuals who do not consent to completing psychological or dietary questionnaires, or to submitting stool samples
3.Individuals who are not healthy enough to participate in vocal training or choral singing
4.Individuals with intestinal diseases (e.g., inflammatory bowel disease, irritable bowel syndrome) or serious gastrointestinal disorders
5.Individuals undergoing treatments or dietary restrictions that substantially affect the gut environment (e.g., long-term antibiotic use)
6.Individuals who are pregnant, breastfeeding, or planning pregnancy during the study period
7.Individuals who are recognized as inappropriate for the participation by the principal investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Nao |
| Middle name | |
| Last name | Kawabata |
Organization
Seitoku University
Division name
Department of Human Nutrition, Faculty of Human Nutrition
Zip code
271-8555
Address
550 Iwase, Matsudo, Chiba, JAPAN
TEL
047-365-1111
kawabata.nao@wa.seitoku.ac.jp
Public contact
Name of contact person
| 1st name | Nao |
| Middle name | |
| Last name | Kawabata |
Organization
Seitoku University
Division name
Department of Human Nutrition, Faculty of Human Nutrition
Zip code
271-855
Address
550 Iwase, Matsudo, Chiba, JAPAN
TEL
047-365-1111
Homepage URL
kawabata.nao@wa.seitoku.ac.jp
Sponsor or person
Institute
Seitoku University
Institute
Department
Personal name
Funding Source
Organization
Institutional funding (Seitoku University)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Seitoku University
Address
550 Iwase, Matsudo, Chiba, JAPAN
Tel
047-365-1111
ethics@wa.seitoku.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 | 04 | Month | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 22 | 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 | 04 | Month | 08 | Day |
Last modified on
| 2026 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068828
