UMIN-CTR Clinical Trial

Basic information
Public title	Study on stress before and after the maternal nursing training in the female college student of the nursing system
Acronym	Measurement of one of an amylase activity value in saliva and autonomic nervous function activity before and after the maternal nursing training in the female college student of the nursing system
Scientific Title	Study on stress before and after the maternal nursing training in the female college student of the nursing system
Scientific Title:Acronym	Measurement of one of an amylase activity value in saliva and autonomic nervous function activity before and after the maternal nursing training in the female college student of the nursing system
Region	Japan

Condition
Condition	Female college student of the nursing system
Classification by specialty	Psychosomatic Internal Medicine Nursing Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Measurement of one of an amylase activity value in saliva and autonomic nervous function activity before and after the maternal nursing training in the female college student of the nursing system
Basic objectives2	Others
Basic objectives -Others	Physiological changes
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Before and after maternal nursing training
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Female college student of the nursing system
Key exclusion criteria	Mental disease
Target sample size	43

Research contact person
Name of lead principal investigator	1st name Hiroe Middle name Last name Washio
Organization	Kansai University of International Studies
Division name	School of Health Sciences
Zip code	673-0521
Address	1-18 Aoyama, Shijimi-cho, Miki, Hyogo 673-0521 Japan
TEL	0794-84-3513
Email	h-washio@kuins.ac.jp

Public contact
Name of contact person	1st name Hiroe Middle name Last name Washio
Organization	Kansai University of Internatoonal Studies
Division name	School of Health Sciences
Zip code	673-0521
Address	1-18 Aoyama, Shijimi-cho, Miki, Hyogo 673-0521 Japan
TEL	0794-84-3513
Homepage URL
Email	h-washio@kuins.ac.jp

Sponsor
Institute	Kio University
Institute
Department

Funding Source
Organization	Kio 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	Kansai Unversity of International Studies
Address	School of Health Sciences
Tel	0794-84-3513
Email	h-washio@kuins.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 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	Suspended
Date of protocol fixation	2016 Year 08 Month 08 Day
Date of IRB	2016 Year 08 Month 15 Day
Anticipated trial start date	2016 Year 08 Month 08 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	No

Management information
Registered date	2016 Year 08 Month 08 Day
Last modified on	2020 Year 05 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027108