UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058741 |
|---|---|
| Receipt number | R000067168 |
| Scientific Title | Effects of thermal stimulation by bed baths on pain threshold: Comparison of skin contact area with towels |
| Date of disclosure of the study information | 2025/08/08 |
| Last modified on | 2025/08/08 14:54:36 |
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Basic information
Public title
Effects of thermal stimulation by bed baths on pain threshold: Comparison of skin contact area with towels
Acronym
Effects of thermal stimulation by bed baths on pain threshold
Scientific Title
Effects of thermal stimulation by bed baths on pain threshold: Comparison of skin contact area with towels
Scientific Title:Acronym
Effects of thermal stimulation by bed baths on pain threshold
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the thermal stimulation effects on pain thresholds during bed bathing, based on differences in the area of skin contact with the towels.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pain thresholds
Key secondary outcomes
Skin surface temperature
Vital signs
Participant's characteristics
Subjective evaluations
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Applying a dry towel at room temperature to the inner side of the forearm (from the wrist to the elbow) for one minute.
Interventions/Control_2
Applying a hot towel to the inner side of the forearm (from the wrist to the elbow) for one minute.
Interventions/Control_3
Applying a hot towel to the inner side of the forearm (Half size of the Intervention 2) for one minute.
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adults
Key exclusion criteria
Persons with skin problems in the intervention site and the measurement site.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | RIKA |
| Middle name | |
| Last name | YANO |
Organization
Faculty of Health Sciences, Hokkaido University
Division name
Fundamental nursing
Zip code
0600812
Address
N12-W5, Kita-ku, Sapporo, Hokkaido
TEL
0117063323
r-yano@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | RIKA |
| Middle name | |
| Last name | YANO |
Organization
Faculty of Health Sciences, Hokkaido University
Division name
Department of Fundamental Nursing
Zip code
0600812
Address
N12-W5, Kita-ku, Sapporo, Hokkaido
TEL
0117063323
Homepage URL
r-yano@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Rika Yano
Funding Source
Organization
Hokkaido University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Health Sciences, Hokkaido University
Address
Kita 12, Nishi 5, Kita-ku Sapporo, Hokkaido 060-0812, Japan
Tel
0117063323
r-yano@med.hokudai.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
北海道
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 08 | 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 | 08 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 20 | 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
Management information
Registered date
| 2025 | Year | 08 | Month | 08 | Day |
Last modified on
| 2025 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067168
