UMIN-CTR Clinical Trial

Basic information
Public title	Effect of Preventive Countermeasures for Low Back Pain to Nurses by Action Research: Focus on the Transformation of Individuals and Organizations and the Effect on Health Related to Low Back Pain
Acronym	Effect of Preventive Countermeasures for Low Back Pain to Nurses by Action Research: Focus on the Transformation of Individuals and Organizations and the Effect on Health Related to Low Back Pain
Scientific Title	Effect of Preventive Countermeasures for Low Back Pain to Nurses by Action Research: Focus on the Transformation of Individuals and Organizations and the Effect on Health Related to Low Back Pain
Scientific Title:Acronym	Effect of Preventive Countermeasures for Low Back Pain to Nurses by Action Research: Focus on the Transformation of Individuals and Organizations and the Effect on Health Related to Low Back Pain
Region	Japan

Condition
Condition	low back pain
Classification by specialty	Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to clarify the effects of action research on back pain prevention measures for ward nurses on personal and organizational changes and health related to back pain.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Recognition of low back pain / prevention in preparation factors (such as knowledge of low back pain, low back pain prevention), attitudes to low back pain prevention (interest in the prevention, sense of crisis, etc.) Burden reduction), support in the surroundings (cooperation system), acquisition of preventive technology in the realization factor (implementation of correct Vinilance), resources available for prevention (preparation of goods, rules)
Key secondary outcomes	Behavioral and organizational transformations and health improvements related to back pain

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Behavior,custom Maneuver
Interventions/Control_1	Introduction of technology for moving on the bed using a plastic bag with low waist load,Health education related to back pain(Once a month for 6 months),Create an organization to prevent back pain
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	20 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	All nurses working in the selected ward
Key exclusion criteria	Persons with specific low back pain or other diseases who cannot obtain the doctor's permission to participate in the study
Target sample size	40

Research contact person
Name of lead principal investigator	1st name TAKUMA Middle name Last name YAMAMOTO
Organization	Japanese Red Cross Nursing University Graduate School of Nursing Doctoral Course
Division name	Fundamental nursing
Zip code	1520004
Address	1-15-8 Takaban, Meguro-ku, Tokyo Gakugeidai Hawk Palace 101
TEL	09030487891
Email	217D113@redcross.ac.jp

Public contact
Name of contact person	1st name YUKARI Middle name Last name KAWAHARA
Organization	Japanese Red Cross Nursing University
Division name	Fundamental nursing
Zip code	1500012
Address	4-1-3 Hiroo, Shibuya-ku, Tokyo
TEL	03-3409-0185
Homepage URL
Email	kawahara@redcross.ac.jp

Sponsor
Institute	Japanese Red Cross Nursing University
Institute
Department

Funding Source
Organization	Japanese Red Cross Nursing 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	Japanese Red Cross Nursing University
Address	4-1-3 Hiroo, Shibuya-ku, Tokyo
Tel	03-3409-0185
Email	kawahara@redcross.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	2019 Year 08 Month 22 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	2019 Year 08 Month 15 Day
Date of IRB	2019 Year 07 Month 29 Day
Anticipated trial start date	2019 Year 09 Month 15 Day
Last follow-up date	2020 Year 07 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	2019 Year 08 Month 19 Day
Last modified on	2019 Year 08 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043038