UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043513 |
|---|---|
| Receipt number | R000049671 |
| Scientific Title | Effects of hearing nature sounds on oxytocin, cortisol concentrations, and heart rate variability |
| Date of disclosure of the study information | 2021/03/03 |
| Last modified on | 2021/03/03 10:05:39 |
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Basic information
Public title
Study on the effect of hearing nature sounds on autonomic nervous function
Acronym
Study on the effect of hearing nature sounds on autonomic nervous function
Scientific Title
Effects of hearing nature sounds on oxytocin, cortisol concentrations, and heart rate variability
Scientific Title:Acronym
Effects of hearing nature sounds on oxytocin, cortisol concentrations, and heart rate variability
Region
| Japan |
Condition
Condition
Healthy adult male
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigated the effects of hearing nature sounds on oxytocin and cortisol concentrations and heart rate variability.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Oxytocin, Cortisol
Key secondary outcomes
Heart rate variability, State-Trait Anxiety Inventory (STAI)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Group hearing nature sounds for 10 minutes
Interventions/Control_2
Group that does not hearing nature sounds for 10 minutes
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
| 60 | years-old | >= |
Gender
Male
Key inclusion criteria
(1) 20-60 year old male, (2) Healthy adult male, (3) Can agree on a schedule.
Key exclusion criteria
(1) Those who are not taking drugs that affect the autonomic nervous system, (2) Those who do not have internal medicine disease
Target sample size
7
Research contact person
Name of lead principal investigator
| 1st name | hidetoshi |
| Middle name | |
| Last name | mori |
Organization
National University Corporation Tsukuba University of Technology
Division name
Department of Health, Faculty of Health Science
Zip code
305-0821
Address
4-12-7 Kasuga, Tsukuba City, Ibaraki Prefecture, 305-8521
TEL
+81-29-856-3570
h.mori.tsukuba@gmail.com
Public contact
Name of contact person
| 1st name | hiroshi |
| Middle name | |
| Last name | kuge |
Organization
Osaka Medical College Hospital
Division name
Department of Anesthesiology and pain clinic
Zip code
569-8686
Address
2-7, daigakumachi Takatsuki city, Osaka prefecture, 569-8686
TEL
+81-90-1487-1151
Homepage URL
sherry@kha.biglobe.ne.jp
Sponsor or person
Institute
National University Corporation Tsukuba University of Technology
Institute
Department
Personal name
Funding Source
Organization
National University Corporation Tsukuba University of Technology
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
National University Corporation Tsukuba University of Technology
Address
4-12-7 Kasuga, Tsukuba City, Ibaraki Prefecture, 305-8521
Tel
+81-29-856-3570
h.mori.tsukuba@gmail.com
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
| 2021 | Year | 03 | Month | 03 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
7
Results
Hearing nature sounds had an effect on oxytocin / cortisol concentration and heart rate, and were expected to have stress-relieving and relaxing effects.
Results date posted
| 2021 | Year | 03 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Hearing nature sounds are sounds that include high frequencies (1 / f rhythm) in the natural world that nature produces, such as the barking of birds, the murmuring of streams, the rubbing of trees, and the sound of waves. Hearing nature sounds have also been pointed out as having a stress-relieving effect. Oxytocin has been reported to heal the body (relaxing effect) by increasing the blood concentration.
Participant flow
The numbers used for outcome analysis, and the numbers used for statistical analysis were the same as those at the start of the study.
Adverse events
There were no unintended effects (adverse events).
Outcome measures
Oxytocin, Cortisol ,Heart rate variability, State-Trait Anxiety Inventory (STAI)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 03 | Day |
Last modified on
| 2021 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049671
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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