UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058918 |
|---|---|
| Receipt number | R000066867 |
| Scientific Title | The Effects of Listening to Sports Commentary on the Radio on the Sleep and Autonomic Nervous Systems of Bedridden Patients: A Crossover Study. |
| Date of disclosure of the study information | 2025/08/28 |
| Last modified on | 2025/08/28 16:53:29 |
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Basic information
Public title
The Effects of Listening to Sports Commentary on the Radio on the Sleep and Autonomic Nervous Systems of Bedridden Patients: A Crossover Study.
Acronym
The Effects of Listening to Sports Commentary on the Radio on the Sleep and Autonomic Nervous Systems of Bedridden Patients: A Crossover Study.
Scientific Title
The Effects of Listening to Sports Commentary on the Radio on the Sleep and Autonomic Nervous Systems of Bedridden Patients: A Crossover Study.
Scientific Title:Acronym
The Effects of Listening to Sports Commentary on the Radio on the Sleep and Autonomic Nervous Systems of Bedridden Patients: A Crossover Study.
Region
| Japan |
Condition
Condition
Bedridden Patient
Classification by specialty
| Intensive care medicine | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study to determine the effects of listening to live sports broadcasts for bedridden patients on the radio on their sleep and autonomic nervous system.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Listen to sports on the radio from the evening until bedtime and monitor their sleep patterns during night.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Listen to sports on the radio from evening until bedtime.
Interventions/Control_2
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals expected to be admitted for 3 or more days, sufficient for study implementation
Individuals interested in watching baseball
Bedridden patient
Individuals from whom written consent for participation in this study can be obtained
Key exclusion criteria
Individuals whose hospitalization was triggered by mental disorders such as depression or anxiety disorders
Individuals deemed inappropriate by the principal investigator or co-investigator
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Sanae |
| Middle name | |
| Last name | Oriyama |
Organization
Graduate School of Biomedical and Health Sciences,Hiroshima University
Division name
Division of Nursing Science
Zip code
734-8553
Address
Kasumi 1-2-3, Minami-ku, Hiroshima, Hiroshima, Japan
TEL
082-257-5355
oriyama@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Yamasaki |
Organization
Graduate School of Biomedical and Health Sciences,Hiroshima University
Division name
Division of Nursing Science
Zip code
734-8553
Address
Kasumi 1-2-3, Minami-ku, Hiroshima, Hiroshima, Japan
TEL
082-257-5355
Homepage URL
yamadai@hirosima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University
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
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3 Minami-Ku, Hiroshima
Tel
082-257-1947
iryo-sinsa@office.hiroshima-u.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
| 2025 | Year | 08 | Month | 28 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 29 | Day |
Last follow-up date
| 2027 | 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 | 08 | Month | 28 | Day |
Last modified on
| 2025 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066867
