UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051173 |
|---|---|
| Receipt number | R000058361 |
| Scientific Title | A Study on Effective Class Style Considering Sleep and Biological Rhythms of Nursing University Students |
| Date of disclosure of the study information | 2023/05/26 |
| Last modified on | 2024/07/22 09:00:18 |
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Basic information
Public title
A Study on Effective Class Style Considering Sleep and Biological Rhythms of Nursing University Students
Acronym
A Study on Effective Class Style Considering Sleep and Biological Rhythms of Nursing University Students
Scientific Title
A Study on Effective Class Style Considering Sleep and Biological Rhythms of Nursing University Students
Scientific Title:Acronym
A Study on Effective Class Style Considering Sleep and Biological Rhythms of Nursing University Students
Region
| Japan |
Condition
Condition
Non clinical population; University students
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the association between class style and sleep among nursing university students.
Basic objectives2
Others
Basic objectives -Others
To investigate the effective style of classes considering sleep and age-dependent biological rhythms among nursing university students.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep
1. Subjective sleep pattern and sleep quality by questionnaire
2. Objective sleep pattern by sleep sensor mat
3. Sleep stages by electroencephalograph
Key secondary outcomes
1. Lifestyle, academic performance by questionnaire
2. Biological rhythm: heart rate variability
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. All nursing students in 3-5 universities which had different class styles (questionnaire survey).
2. Twenty students from each university (sleep monitoring survey).
Key exclusion criteria
1. N/A (questionnaire survey).
2. Students who have skin problems(sleep monitoring survey).
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Masahide |
| Middle name | |
| Last name | Kondo |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
305-8577
Address
1-1-1, Tennodai, Tsukuba, Ibaraki
TEL
029-853-3255
mkondo@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Momoko |
| Middle name | |
| Last name | Kimura |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
3058577
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3255
Homepage URL
momoko.kayaba@gmail.com
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Masahide Kondo
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba
Address
1-1-1, Tennodai, Tsukuba, Ibaraki
Tel
029-853-3255
momoko.kayaba@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
つくば国際大学（茨城県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 26 | 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
| 2023 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Web questionnaire survey: The questionnaire included questions on sleep patterns, sleep-related symptoms, and lifestyle. and academic performance.
2. Sleep monitoring survey: One week of sleep pattern monitoring was planned. On the second day, sleep was measured using an EEG.
Management information
Registered date
| 2023 | Year | 05 | Month | 26 | Day |
Last modified on
| 2024 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058361
