UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060723 |
|---|---|
| Receipt number | R000069472 |
| Scientific Title | Research on reducing inpatient stress through sound |
| Date of disclosure of the study information | 2026/02/24 |
| Last modified on | 2026/02/21 12:01:49 |
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Basic information
Public title
Research on reducing inpatient stress through sound
Acronym
Research on reducing inpatient stress through sound
Scientific Title
Research on reducing inpatient stress through sound
Scientific Title:Acronym
Research on reducing inpatient stress through sound
Region
| Japan |
Condition
Condition
pregnant women
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
While it is known that playing music for inpatients can lead to a reduction in stress and anxiety, this study aims to clarify the specific characteristics of music that effectively alleviate anxiety.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between musical frequency components and salivary cortisol, heart rate variability (HRV), near-infrared spectroscopy (NIRS) of the epidermis, electroencephalogram (EEG) data, and POMS 2 scores.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Music A will be presented to the participants via either speakers or headphones.
Interventions/Control_2
Music B will be presented to the participants via either speakers or headphones.
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
| 18 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Female
Key inclusion criteria
1 Age 18 years or older at the time of informed consent.
2 Inpatients who have been hospitalized for 5 days or longer.
3 Individuals who have provided voluntary written informed consent after receiving a full explanation and demonstrating sufficient understanding of the study.
Key exclusion criteria
1 Individuals with hearing impairments.
2 Patients with pituitary or adrenal dysfunction, or those currently receiving steroid therapy.
3 Any other individuals judged by the principal investigator to be unsuitable as study participants.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Umazume |
Organization
Hokkaido University Hospital
Division name
Obstetrics
Zip code
060-8638
Address
N15W7, Kita-ku, Sapporo, Hokkaido
TEL
011-706-5941
takeuma@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Umazume |
Organization
Hokkaido
Division name
Obstetrics
Zip code
060-8638
Address
N15W7, Kita-ku, Sapporo, Hokkaido
TEL
011-706-5941
Homepage URL
takeuma@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Institutional Review Board (IRB) of Hokkaido University Hospital
Address
5 Chome, Kita 14-jo Nishi, Kita-ku, Sapporo, Hokkaido
Tel
011-716-1161
crjimu@huhp.hokudai.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
| 2026 | Year | 02 | Month | 24 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 03 | Month | 14 | Day |
Last follow-up date
| 2026 | 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
| 2026 | Year | 02 | Month | 21 | Day |
Last modified on
| 2026 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069472
