UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052987 |
|---|---|
| Receipt number | R000060449 |
| Scientific Title | Effects of Periocular skin warming on Napping during Night Shift Naps |
| Date of disclosure of the study information | 2024/02/01 |
| Last modified on | 2023/12/04 11:22:31 |
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Basic information
Public title
Effects of Periocular skin warming on Napping during Night Shift Naps
Acronym
Effects of Periocular skin warming on Napping during Night Shift Naps
Scientific Title
Effects of Periocular skin warming on Napping during Night Shift Naps
Scientific Title:Acronym
Effects of Periocular skin warming on Napping during Night Shift Naps
Region
| Japan |
Condition
Condition
Healthy nursing and care staff
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to test whether periocular thermal stimulation during night shift naps promotes nap onset and improves nap quality in nursing and caregiving staff.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep EEG during night shift nap
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
Periocular skin warming
Interventions/Control_2
Control
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 and Female
Key inclusion criteria
(1) 20-60 years old, (2) nursing/caregiving staff working in a convalescent ward, (3) engaged in night shift in the same department for more than 1 year, (4) engaged in night shift more than 2 times per month.
Key exclusion criteria
(1) Night shift, (2) taking sleeping pills, (3) having sleep disorder, (4) diagnosed with obstructive sleep apnea (OSA), (5) usually sleepwalking, (6) pregnant, (7) diagnosed with premenstrual syndrome (PMS), (8) usually working night shifts and not taking a nap, (9) heat sensitive, (10) disease, inflammation, scar or swelling in the eyes or eye area.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Ozaki |
Organization
Tohoku University
Division name
Department of Gerontological and Home Healthcare Nursing
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7919
aozaki@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Isuzu |
| Middle name | |
| Last name | Nakamoto |
Organization
Tohoku University
Division name
Department of Gerontological and Home Healthcare Nursing
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7919
Homepage URL
isuzu.nakamoto.c7@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2024 | Year | 02 | Month | 01 | 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
| 2024 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 04 | Day |
Last modified on
| 2023 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060449
