UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048664 |
|---|---|
| Receipt number | R000055452 |
| Scientific Title | Randomized controlled trial for the effects of music on the maintenance and improvement of mental health |
| Date of disclosure of the study information | 2022/08/16 |
| Last modified on | 2022/08/14 14:32:21 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
epi@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055452
