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 2022/10/01 18:45:40

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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

Email

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


Email

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

Email

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


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

2022 Year 10 Month 01 Day

Date of IRB


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

2022 Year 10 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055921


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name