UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050101 |
|---|---|
| Receipt number | R000057076 |
| Scientific Title | Effectiveness of stoma care video instruction in promoting the acquisition of stoma self-care. |
| Date of disclosure of the study information | 2023/01/22 |
| Last modified on | 2023/01/22 11:56:28 |
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Basic information
Public title
Effectiveness of stoma care video instruction in promoting the acquisition of stoma self-care.
Acronym
Effectiveness of stoma care video instruction in promoting the acquisition of stoma self-care.
Scientific Title
Effectiveness of stoma care video instruction in promoting the acquisition of stoma self-care.
Scientific Title:Acronym
Effectiveness of stoma care video instruction in promoting the acquisition of stoma self-care.
Region
| Japan |
Condition
Condition
rectal tumor
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine whether creating a stoma care video and using it in preoperative stoma orientation is effective in promoting patients' acquisition of stoma self-care, compared to teaching methods using paper media only.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stoma self-care capacity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Guidance will be given using pamphlets.
Interventions/Control_2
Brochures and videos will be used for guidance.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who are having a stoma placed for the first time.
Key exclusion criteria
Patient is unable to care for the stoma by himself/herself due to problems with manual dexterity.
The patient is unable to care for the stoma by himself/herself due to cognitive decline.
The patient is unable to perform preoperative stoma orientation due to emergency stoma creation, etc.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuriko |
| Middle name | |
| Last name | Narita |
Organization
Hirosaki University Hospital
Division name
nursing department
Zip code
036-8563
Address
53 Honmachi, Hirosaki-shi, Aomori
TEL
0172-33-5111
kn5263@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuriko |
| Middle name | |
| Last name | Narita |
Organization
Hirosaki University Hospital
Division name
nursing department
Zip code
036-8563
Address
53 Honmachi, Hirosaki-shi, Aomori
TEL
0172-33-5111
Homepage URL
kn5263@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University
Institute
Department
Personal name
Yuriko Narita
Funding Source
Organization
None
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
Ethics Committee, Graduate School of Medicine, Hirosaki University School of Medicine
Address
53 Honmachi, Hirosaki-shi, Aomori
Tel
0172-33-5111
rinri@hirosaki-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
| 2023 | Year | 01 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 01 | Month | 22 | Day |
Last modified on
| 2023 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057076
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
