Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058998) titled 'Active and creative musical activities by children receiving social and medical support' on Oct. 1.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Department of Neuropsychiatry, Faculty of Medical Sciences, University of Fukui
Condition:
Condition - Children in child welfare facilities, children requiring medical support, children in special needs schools.
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study examines the effects of group music activities on mental symptoms and behavioral issues among children residing in child welfare facilities, children requiring medical support, and children attending special needs schools. It also aims to foster peer support by having children teach each other instruments and collaboratively create music and expressive techniques.
In implementing this program, we prioritize the children's perspectives and feelings above all else. We will regularly listen to the opinions of participating children and strive to incorporate them into the expressive activities as much as possible, aiming for a collaborative creation process. We believe therapeutic interventions using music - a medium that is "familiar" and "enjoyable" - hold significant value. We seek to verify the power of music not only to "resolve emotional distress" but also to "enrich life."
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Instruct participants in playing their chosen instruments, such as guitar or drums, and conduct joint ensemble practice sessions.There will be a total of 20 sessions every other week.
Eligibility:
Age-lower limit - 6
years-old
=
Gender - Male and Female
Key inclusion criteria - The program will be open to those who meet all of the following criteria
1. Age: At least 6 years old and no older than 18 years old at the time of obtaining consent.
2. Gender: Any gender
3. Children in child welfare facilities, children requiring medical support, children in special needs schools.
4. Persons who have been fully informed about their participation in this study, and who have given their assent and written consent based on sufficient understanding by themselves or by their surrogate.
Key exclusion criteria - Persons who fall under any one of the following shall be excluded as eligible
1. Those whose age is less than 6 years old or more than 19 years old
2. Persons with hearing impairment
3. Persons with visual impairment
4. Other patients deemed inappropriate as research subjects by the principal investigator.
Target Size - 10
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 01 Day
Date of IRB - 2025 Year 03 Month 17 Day
Anticipated trial start date - 2025 Year 10 Month 01 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067472
Disclaimer: Curated by HT Syndication.