UMIN-CTR Clinical Trial

Basic information
Public title	Randomized controlled trial for the effects of music on the maintenance and improvement of mental health
Acronym	Randomized controlled trial for the effects of music on mental health
Scientific Title	Randomized controlled trial for the effects of music on the maintenance and improvement of mental health
Scientific Title:Acronym	Randomized controlled trial for the effects of music on mental health
Region	Japan

Condition
Condition	mental health
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the relationship between music therapy and factors related to stress and anxiety in healthy subjects with subjective stress in daily life and to examine the degree of stress and anxiety before and after the intervention
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in stress markers (salivary chromogranin A, salivary cortisol, salivary redox potential) for a month
Key secondary outcomes	Subjective stress Obesity and abdominal circumference measurement Autonomic nerve function test (heart rate, sympathetic and parasympathetic functions by heart rate variability analysis) Questionnaires (psychological health (depressive symptoms, well-being), lifestyle, subjective symptoms, and Health-related quality of life (SF8), ) blood pressure

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	1-month intervention with music listening everyday by smartphone or computer using a music therapy application/ normal daily life
Interventions/Control_2	1-month intervention with music listening everyday by smartphone or computer using a music therapy application/ normal daily life
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	(1)Men and women over 20 years old and able to participate in the inspection and intervention. (2)Smartphone or computer users (3) No history of serious mental illness in the past (but may participate if symptoms are stable and doctor's permission is obtained) (4) Those who have received a full explanation of their participation in this study and have given their free and voluntary written consent based on a full understanding of the study.
Key exclusion criteria	Other than the above
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Tetsuya Middle name Last name Ohira
Organization	Fukushima Medical University School of Medicine
Division name	Department of Epidemiology
Zip code	960-1295
Address	Hikarigaoka 1, Fukushima-shi
TEL	0245471343
Email	teoohira@fmu.ac.jp

Public contact
Name of contact person	1st name Akira Middle name Last name Yoneshiro
Organization	Fukushima Medical University School of Medicine
Division name	Department of Epidemiology
Zip code	960-1295
Address	Hikarigaoka 1, Fukushima-shi
TEL	0245471343
Homepage URL
Email	epi@fmu.ac.jp

Sponsor
Institute	Fukushima Medical University
Institute
Department

Funding Source
Organization	self-financing
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	Ethics Review Committee, Fukushima Medical University
Address	Hikarigaoka 1, Fukushima-shi, Fukushima -ken
Tel	024-547-1825
Email	rs@fmu.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	2022 Year 08 Month 16 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	2022 Year 07 Month 26 Day
Date of IRB	2022 Year 07 Month 22 Day
Anticipated trial start date	2022 Year 08 Month 12 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 08 Month 14 Day
Last modified on	2022 Year 08 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055452