UMIN-CTR Clinical Trial

Basic information
Public title	Is e-learning useful to understand neonatal pain in NICUs ?
Acronym	Effect of e-learning on pain measurement of neonates in NICUs.
Scientific Title	Effect of e-learning on neonatal pain measurement among NICU nurses - A randomized study.
Scientific Title:Acronym	Effect of e-learning on pain measurement of neonates in NICUs.
Region	Japan

Condition
Condition	Neonates in NICUs
Classification by specialty	Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Develop and test an e-learning program for measuring neonatal pain in NICUs.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correct answer rate of knowledge test, score of FSPAPI and score of Japanese version of the PIPP.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	The e-learning program for measurement of neonatal pain in NICUs.
Interventions/Control_2	Self-learning of neonatal pain measurement in NICUs.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Certified Nurses in Neonatal Intensive Care who spend their name and affliction. 2. New learner of this e-learning. 3. Agreeing participate this study.
Key exclusion criteria	1. Nurse manager 2. Not working in NICU or GCU 3. Consider it ineligible
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Mio Middle name Last name Ozawa
Organization	Hiroshima University
Division name	Graduate School of Biomedical & Health Sciences
Zip code	734-8553
Address	1-2-3 Kasumi, Minami-ku, Hiroshima 734-8553, Japan
TEL	082-257-5432
Email	ozawamio@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Sayo Middle name Last name Fukushima
Organization	Hiroshima University
Division name	Graduate School of Biomedical & Health Sciences
Zip code	734-8553
Address	1-2-3 Kasumi, Minami-ku, Hiroshima 734-8553, Japan
TEL	082-257-5432
Homepage URL
Email	sfuku@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
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	Ethical Committee for Clinical Research of Hiroshima University
Address	1-2-3 Kasumi, Minami-ku, Hiroshima 734-8553, Japan
Tel	082-257-1732
Email	protocol@cimr.hiroshima-u.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	2020 Year 01 Month 31 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	Main results already published
Date of protocol fixation	2019 Year 12 Month 05 Day
Date of IRB	2020 Year 01 Month 16 Day
Anticipated trial start date	2020 Year 01 Month 29 Day
Last follow-up date	2021 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	2020 Year 01 Month 23 Day
Last modified on	2022 Year 07 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043864