UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060500 |
|---|---|
| Receipt number | R000069210 |
| Scientific Title | Comparison of warming behaviors to reduce hand coldness during nursing care: a randomized crossover trial |
| Date of disclosure of the study information | 2026/01/28 |
| Last modified on | 2026/01/28 16:22:48 |
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Basic information
Public title
A study comparing warming behaviors to reduce hand coldness during nursing care
Acronym
Hand Warming Behavior Study during Nursing Care
Scientific Title
Comparison of warming behaviors to reduce hand coldness during nursing care: a randomized crossover trial
Scientific Title:Acronym
HAND-WARM Trial
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare the immediate effects of multiple hand-warming behaviors that can be performed by nurses prior to hand hygiene on physiological indicators, such as hand skin temperature and blood flow, as well as subjective indicators, such as thermal sensation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in hand skin temperature
Key secondary outcomes
Area under the curve (AUC) of hand skin temperature over time
Change in hand blood flow and its area under the curve (AUC)
Subjective measures of thermal sensation and thermal comfort
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Standard alcohol-based hand hygiene.
Interventions/Control_2
Hand rubbing for 10 seconds prior to standard hand hygiene.
Interventions/Control_3
Hand warming using a portable hand warmer preheated to approximately 50 C for 30 seconds prior to standard hand hygiene.
Interventions/Control_4
Proximal warming using an elbow warmer preheated to approximately 48 C for 15 minutes prior to standard hand hygiene.
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
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
1. Adult women aged 18 to under 40 years
2. Able to maintain a resting posture during measurements
3. Able to understand the study and provide written informed consent
Key exclusion criteria
1. History of cardiovascular or peripheral circulatory disorders that may affect circulation
2. Regular use of medications affecting the autonomic nervous system
3. Skin disorders or sensitivity of the hands or forearms that may interfere with alcohol-based hand hygiene or measurements
4. Pregnant women
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Miyuki |
| Middle name | |
| Last name | Suzuki |
Organization
Hyogo Medical University
Division name
School of Nursing
Zip code
650-8530
Address
1-3-6 Minatojima, Chuo-ku, Kobe, Hyo-go, Japan
TEL
078-304-3000
mioka@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Miyuki |
| Middle name | |
| Last name | Suzuki |
Organization
Hyogo Medical University
Division name
School of Nursing
Zip code
650-8530
Address
1-3-6 Minatojima, Chuo-ku, Kobe, Hyo-go, Japan
TEL
078-304-3000
Homepage URL
mioka@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo Medical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
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
Hyogo Medical University
Address
1-1 Mukogawacho, Nishinomiya, Hyogo, Japan
Tel
0798-45-6066
rinri@hyo-med.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
兵庫医科大学
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 04 | 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
| 2026 | Year | 01 | Month | 28 | Day |
Last modified on
| 2026 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069210
