UMIN-CTR Clinical Trial

Basic information
Public title	Acceptance and commitment training for new nursing staff: A pre-post trial
Acronym	Acceptance and commitment training for new nursing staff: A pre-post trial
Scientific Title	Acceptance and commitment training for new nursing staff: A pre-post trial
Scientific Title:Acronym	Acceptance and commitment training for new nursing staff: A pre-post trial
Region	Japan

Condition
Condition	none
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the effectiveness of acceptance and commitment training for new nursing staff
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Professional Quality of Life Scale version 5(ProQOL-5) ProQOL is evaluated at the end of training and 1 month, 6months after the training.
Key secondary outcomes	1.Perceived Stress Scale 2.Acceptance and Action Questionnaire-2 3.Cognitive Fudion Questionnaire 4.Valuing Questionnaire 5.The Mindful Attention Awareness Scale 6.Three Senses of the Selves Questionnaire

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
Interventions/Control_1	Group acceptance and commitment training; 90minutes, 4 sessions plus 1 booster session
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	Nursing staff who got a job at Yokosuka Kyos ai Hospital in April 2021
Key exclusion criteria	none
Target sample size	55

Research contact person
Name of lead principal investigator	1st name Hiroo Middle name Last name Mitsusada
Organization	Yokosuka Kyosai Hospital, Federation of National Public Service Personnel Mutual Aid Associations
Division name	Department of Psychiatry
Zip code	238-8558
Address	1-16 Yonegahamadori, Yokosuka, Kanagawa, Japan
TEL	0468222710
Email	hiroo.mitsusada@ykh.gr.jp

Public contact
Name of contact person	1st name Hiroo Middle name Last name Mitsusada
Organization	Yokosuka Kyosai Hospital, Federation of National Public Service Personnel Mutual Aid Associations
Division name	Department of Psychiatry
Zip code	238-8558
Address	1-16 Yonegahamadori, Yokosuka, Kanagawa, Japan
TEL	0468222710
Homepage URL
Email	hiroo.mitsusada@ykh.gr.jp

Sponsor
Institute	Department of Psychiatry, Yokosuka Kyosai Hospital, Federation of National Public Service Personnel Mutual Aid Associations
Institute
Department

Funding Source
Organization	Department of Psychiatry, Yokosuka Kyosai Hospital, Federation of National Public Service Personnel Mutual Aid Associations
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Yokosuka Kyosai Hospital, Federation of National Public Service Personnel Mutual Aid Associations
Address	1-16 Yonegahamadori, Yokosuka, Kanagawa, Japan
Tel	0468222710
Email	hiroo.mitsusada@ykh.gr.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	国家公務員共済組合連合会横須賀共済病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2021 Year 03 Month 01 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	Completed
Date of protocol fixation	2021 Year 02 Month 19 Day
Date of IRB	2021 Year 02 Month 19 Day
Anticipated trial start date	2021 Year 04 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry	2022 Year 03 Month 31 Day
Date trial data considered complete	2022 Year 03 Month 31 Day
Date analysis concluded	2022 Year 05 Month 30 Day

Other
Other related information

Management information
Registered date	2021 Year 02 Month 22 Day
Last modified on	2022 Year 08 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049291