UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035588 |
|---|---|
| Receipt number | 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 | 2023/07/25 14:07:54 |
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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
Fukuoka International University of Health and Welfare
Division name
Department of nursing
Zip code
8140001
Address
1-7-4 Momochihama, Sawara-ku, Fukuoka
TEL
0924070805
tkuroki@takagigakuen.ac.jp
Public contact
Name of contact person
| 1st name | Tsukasa |
| Middle name | |
| Last name | Kuroki |
Organization
Fukuoka International University of Health and Welfare
Division name
Department of nursing
Zip code
8140001
Address
1-7-4 Momochihama, Sawara-ku, Fukuoka
TEL
0924070805
Homepage URL
tkuroki@takagigakuen.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
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
International University of Health and Welfare
Address
3-6-40 Momochihama, Sawara-ku, Fukuoka
Tel
092-407-0805
fiuhw-rinri@takagigakuen.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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
0
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
| 2017 | Year | 04 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2023 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040541
