UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049088 |
|---|---|
| Receipt number | R000055921 |
| Scientific Title | Effects of bed baths with cotton towels and disposable towels on skin temperature and subjective evaluation |
| Date of disclosure of the study information | 2022/10/03 |
| Last modified on | 2024/10/07 15:45:50 |
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Basic information
Public title
Effects of bed baths with cotton towels and disposable towels on skin temperature and subjective evaluation
Acronym
Effects of bed baths with cotton towels and disposable towels on skin temperature and subjective evaluation
Scientific Title
Effects of bed baths with cotton towels and disposable towels on skin temperature and subjective evaluation
Scientific Title:Acronym
Effects of bed baths with cotton towels and disposable towels on skin temperature and subjective evaluation
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effects of bed baths with cotton towels and disposable towel on the subjects' skin temperature and subjective evaluation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin temperature
Subjective evaluation
Key secondary outcomes
Stratum corneum hydration
Trans epidermal water loss
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Perform bed bath with cotton towel once a day.
Interventions/Control_2
Perform bed bath with thin disposable towel once a day.
Interventions/Control_3
Perform bed bath with thick disposable towel once a day.
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
The parson that a document agreement by the free was provided after enough understanding after having received enough explanation on participating to this study.
Key exclusion criteria
1. Persons with skin wounds
2. Persons with skin problems
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Inaho |
| Middle name | |
| Last name | Shishido |
Organization
Faculty of Health Sciences, Hokkaido University
Division name
Department of Fundamental Nursing
Zip code
060-0812
Address
Kita 12, Nishi 5, Kita-ku Sapporo, Hokkaido 060-0812, Japan
TEL
011-706-3718
inaho_s@hs.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Inaho |
| Middle name | |
| Last name | Shishido |
Organization
Faculty of Health Sciences, Hokkaido University
Division name
Department of Fundamental Nursing
Zip code
060-0812
Address
Kita 12, Nishi 5, Kita-ku Sapporo, Hokkaido 060-0812, Japan
TEL
011-706-3718
Homepage URL
inaho_s@hs.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Hokkaido 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
Faculty of Health Sciences, Hokkaido University
Address
Kita 12, Nishi 5, Kita-ku Sapporo, Hokkaido 060-0812, Japan
Tel
011-706-3718
inaho_s@hs.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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 03 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Published
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
10
Results
Thick and thin towels significantly decreased skin temperature after bed bathing (P<.001). SCH increased significantly after wiping in all conditions (P<.001). TEWL showed significantly increased after wiping in all conditions (P<.001). Only when wiping with a thick towel were SCH and TEWL higher than before wiping until 15 minutes after wiping (P<.01). Subjective evaluation of warmth and softness differed significantly between conditions (P<.05).
Results date posted
| 2024 | Year | 10 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy women
Participant flow
Three conditions of bed baths were performed on the 10 participants who consented to participate. The order in which the three conditions were performed was randomly assigned. All subjects completed the intervention and evaluation, and there were no missing data.
Adverse events
There were no adverse events.
Outcome measures
Skin temperature, stratum corneum hydration (SCH), transepidermal water loss (TEWL), subjective evaluation
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 12 | 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
| 2022 | Year | 10 | Month | 01 | Day |
Last modified on
| 2024 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055921
