UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059835 |
|---|---|
| Receipt number | R000068426 |
| Scientific Title | Verification of the Effects of Tactile Care on Sleep Based on Differences in Implementation Frequency and Time of Day |
| Date of disclosure of the study information | 2025/11/25 |
| Last modified on | 2025/11/20 15:36:55 |
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Basic information
Public title
Verification of the Effects of Tactile Care on Sleep Based on Differences in Implementation Frequency and Time of Day
Acronym
Verification of the Effects of Tactile Care on Sleep
Scientific Title
Verification of the Effects of Tactile Care on Sleep Based on Differences in Implementation Frequency and Time of Day
Scientific Title:Acronym
Verification of the Effects of Tactile Care on Sleep
Region
| Japan |
Condition
Condition
Adult female
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether sleep patterns change based on the frequency and timing of tactile care implementation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep Efficiency
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Comparison of Implementation Frequency: Tactile care (20 minutes with both hands) is performed once a week for one month and three times a week for one month. A one-month break period is scheduled between these sessions.
Interventions/Control_2
Comparison of Implementation Times: Tactile care (20 minutes with both hands) is performed for one month during daytime hours and for one month during evening hours. A one-month break period is scheduled between these sessions.
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
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
Be Healthy
Key exclusion criteria
1.Currently taking medications that affect sleep
2.Suffering from mental illness or physical conditions accompanied by pain
3.Experiencing significant fluctuations in daily sleep schedules
4.Undergoing treatment for skin conditions on the hands
5.Pregnant, breastfeeding, or possibly pregnant
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Kanae |
| Middle name | |
| Last name | Kitano |
Organization
University of Fukui
Division name
Division of Nursing, Faculty of Medical Sciences, Faculties
Zip code
910-1193
Address
23-3 Matsuokashimoaizuki Eiheiji Yoshida Fukui
TEL
0776-61-8548
kyoshi@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Kanae |
| Middle name | |
| Last name | Kitano |
Organization
University of Fukui
Division name
Division of Nursing, Faculty of Medical Sciences, Faculties
Zip code
910-1193
Address
23-3 Matsuokashimoaizuki Eiheiji Yoshida Fukui
TEL
0776-61-8548
Homepage URL
kyoshi@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Division for Research Promotion for Matsuoka Campus
Address
23-3 Matsuokashimoaizuki Eiheiji Yoshida Fukui
Tel
0776-61-8614
rinsho-rinri@ml.u-fukui.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 | 11 | Month | 25 | 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
| 2025 | Year | 11 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 05 | 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 | 11 | Month | 20 | Day |
Last modified on
| 2025 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068426
