UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056717 |
|---|---|
| Receipt number | R000064828 |
| Scientific Title | A Study of the Psychological and Physiological Effects of the Sound of a Pipe Organ |
| Date of disclosure of the study information | 2025/01/25 |
| Last modified on | 2025/01/14 19:49:30 |
* 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
A Study of the Psychological and Physiological Effects of the Sound of a Pipe Organ
Acronym
A Study of the Psychological and Physiological Effects of the Sound of a Pipe Organ
Scientific Title
A Study of the Psychological and Physiological Effects of the Sound of a Pipe Organ
Scientific Title:Acronym
A Study of the Psychological and Physiological Effects of the Sound of a Pipe Organ
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the psychological and physiological effects of the subject on stress reduction before and after listening to a pipe organ
performance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Saliva stress biomarkers
Key secondary outcomes
Autonomic nervous system
POMS2
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Live pipe organ performance
Interventions/Control_2
Viewing of CD of pipe organ performances.
Interventions/Control_3
Viewing of DVD of pipe organ performances.
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
| 25 | years-old | <= |
Age-upper limit
| 33 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. The applicant must be an adult in good health at the time of consent
2. Those who, after receiving a full explanation and understanding of their participation in the study, have given their free and voluntary written consent to participate in the study.
Key exclusion criteria
1. Those who are unable to secure sufficient saliva volume through saliva sampling.
2. Those taking psychotropic drugs such as antidepressants.
3. Other persons deemed inappropriate as research subjects by the principal investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Akio |
| Middle name | |
| Last name | Mizushima |
Organization
Juntendo University Hospital
Division name
Palliative Care
Zip code
113-8431
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
akiom@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Akio |
| Middle name | |
| Last name | Mizushima |
Organization
Juntendo University Hospital
Division name
Palliative Care
Zip code
113-8431
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
akiom@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research and Ethics Committee, Faculty of Medicine, Juntendo University School of Medicine
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel
03-5802-1584
hongo-rinri@juntendo.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
関東学院大学礼拝堂（神奈川県）
順天堂大学関連施設（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
24
Results
40th Annual Meeting of the Japanese Association of Stress Science, Utsunomiya
Results date posted
| 2025 | Year | 01 | Month | 14 | Day |
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
Completed
Date of protocol fixation
| 2023 | Year | 03 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2025 | Year | 01 | Month | 14 | Day |
Last modified on
| 2025 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064828
