Tokyo, April 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061202) titled 'Study on the Effects of Vocal Music Education on the Mental Well-being of Women's University Students' on April 8.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Seitoku University
Condition:
Condition - Not applicable (educational intervention study on healthy female university students)
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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.
Eligibility:
Age-lower limit - 18
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 Size - 30
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068828
Disclaimer: Curated by HT Syndication.