UMIN-CTR Clinical Trial

Basic information
Public title	Study on visualization of expert nurses' hand skill in nursing art and its utilization in learning
Acronym	Study on visualization of expert nurses' hand skill in nursing art and its utilization in learning
Scientific Title	Study on visualization of expert nurses' hand skill in nursing art and its utilization in learning
Scientific Title:Acronym	Study on visualization of expert nurses' hand skill in nursing art and its utilization in learning
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Nursing Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	1.The purpose of this study is to visualize the expert hand skill in a daily nursing act by observing parts of the fingers and palms used for their act and their intensity . 2.Further,the authors aim at examining learning effects obtained by applying the visualized hand skill.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Contact pressure of the hand
Key secondary outcomes	Heart rate variability Visual analog scale

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Postural Change
Interventions/Control_2
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Healthy adults 2.Persons who describe the consent for reserch participation in oral and a documents
Key exclusion criteria	1.Persons who has suffered from illness
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Shinji Middle name Last name Akeno
Organization	Sapporo City University
Division name	Graduate School Nursing
Zip code	0600011
Address	Kita 11 Nishi 13,Chuo-ku,Sapporo,Hokkaido
TEL	011-726-2500
Email	1275001@st.scu.ac.jp

Public contact
Name of contact person	1st name Shinji Middle name Last name Akeno
Organization	Sapporo City University
Division name	Graduate School Nursing
Zip code	0600011
Address	Kita 11 Nishi 13,Chuo-ku,Sapporo,Hokkaido
TEL	011-726-2500
Homepage URL
Email	1275001@st.scu.ac.jp

Sponsor
Institute	Sapporo City University
Institute
Department

Funding Source
Organization	Sapporo City 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	Sapporo City University
Address	Kita 11 Nishi 13,Chuo-ku,Sapporo,Hokkaido
Tel	011-726-2500
Email	1275001@st.scu.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	2016 Year 04 Month 27 Day

Related information
URL releasing protocol	https://scu.repo.nii.ac.jp/?action=pages_view_main&active_action=repository_view_main_item_detail&it
Publication of results	Published

Result
URL related to results and publications	https://scu.repo.nii.ac.jp/?action=pages_view_main&active_action=repository_view_main_item_detail&it
Number of participants that the trial has enrolled	71
Results	There was a significant difference in the pressures applied at contact points of the fingers and palms in postural change actions between groups S and LS. These results allowed criteria to be defined for pressure points of fingers and palms for skilled use of the hands. These results suggest that a training method utilizing pressure levels as visual feedback is effective to learn skilled use of the hands.
Results date posted	2022 Year 06 Month 06 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	32 nurses and 39 students
Participant flow	Subjects who were judged to have given greater and lesser comfort to patients were categorized into the Skilled (S) and Less Skilled (LS) groups,
Adverse events	Not applicable
Outcome measures	Pressures applied at the contact points of the fingers and palms Subjective and physiological evaluations of patients
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 25 Day
Date of IRB	2017 Year 04 Month 16 Day
Anticipated trial start date	2016 Year 04 Month 14 Day
Last follow-up date	2019 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	2016 Year 04 Month 27 Day
Last modified on	2022 Year 06 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025481