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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035588
Receipt No. R000040541
Scientific Title Stress management intervention for stress maladjustment in inflammatory bowel disease patients
Date of disclosure of the study information 2019/01/18
Last modified on 2019/07/22

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Basic information
Public title Stress management intervention for stress maladjustment in inflammatory bowel disease patients
Acronym Stress management intervention in inflammatory bowel disease patients
Scientific Title Stress management intervention for stress maladjustment in inflammatory bowel disease patients
Scientific Title:Acronym Stress management intervention in inflammatory bowel disease patients
Region
Japan

Condition
Condition Inflammatory bowel disease
Classification by specialty
Gastroenterology Endocrinology and Metabolism Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Improvement by stress management intervention of stress-coping abilities and pathological conditions in inflammatory bowel disease patients (three patients each with Crohn's disease and ulcerative colitis).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Before and after stress management intervention (6 weeks), the following data are analyzed and evaluated: beta-endorphin, adrenaline, noradrenaline, CRH, ACTH, cortisol, IL-6, TNFalpha, Japanese version of the General Self-Efficacy Scale, sense of coherence, Japanese Perceived Stress Scale, Tokyo University Egogram New Vern2.
Key secondary outcomes

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 Mindfulness, a type of stress management, is conducted for 2 hours once a week (six times in total).
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

Not applicable
Gender Male and Female
Key inclusion criteria Inflammatory bowel disease patients aged >=18 years in remission phase (CRP<2, 0<=IOIBD<2).
Key exclusion criteria Inflammatory bowel disease patients being treated with prednisolone.
Inflammatory bowel disease patients with CRP>=2 and IOIBD>=2.
Target sample size 6

Research contact person
Name of lead principal investigator
1st name Tsukasa
Middle name
Last name Kuroki
Organization Teikyo University Faculty of Fukuoka Medical Technology
Division name Department of nursing
Zip code 8368505
Address 6-22 Misaki-mach, Omuta, Fukuoka, Japan
TEL 0944578333
Email kuroki@fmt.teikyo-u.ac.jp

Public contact
Name of contact person
1st name Tsukasa
Middle name
Last name Kuroki
Organization Teikyo University Faculty of Fukuoka Medical Technology
Division name Department of nursing
Zip code 8368505
Address 6-22 Misaki-mach, Omuta, Fukuoka, Japan
TEL 0944578333
Homepage URL
Email kuroki@fmt.teikyo-u.ac.jp

Sponsor
Institute Teikyo University Faculty of Fukuoka Medical Technology
Institute
Department

Funding Source
Organization Japan science and technology agency
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Saga Medical School Department of internal Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization Teikyo University Faculty of Fukuoka Medical Technology
Address 6-22 Misaki-mach, Omuta, Fukuoka, Japan
Tel 0944578333
Email katuragawa@fmt.teikyo-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
2019 Year 01 Month 18 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 Open public recruiting
Date of protocol fixation
2017 Year 04 Month 06 Day
Date of IRB
2019 Year 03 Month 04 Day
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
2020 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
2019 Year 01 Month 18 Day
Last modified on
2019 Year 07 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040541

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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