UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004908 |
|---|---|
| Receipt number | R000005846 |
| Scientific Title | The study of the effectiveness of color images on stress reduction for isolated patients in bioclean room |
| Date of disclosure of the study information | 2011/01/20 |
| Last modified on | 2012/02/24 07:00:36 |
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Basic information
Public title
The study of the effectiveness of color images on stress reduction for isolated patients in bioclean room
Acronym
The study of the effectiveness of color images on stress reduction
Scientific Title
The study of the effectiveness of color images on stress reduction for isolated patients in bioclean room
Scientific Title:Acronym
The study of the effectiveness of color images on stress reduction
Region
| Japan |
Condition
Condition
Hematopoietic neoplasms
Classification by specialty
| Hematology and clinical oncology | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the effectiveness of color images on stress reduction for isolated patients in bioclean room
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
STAI(State-Trait Anxiety Inventory-Form)
Key secondary outcomes
The evaluation of QOL
(Incidence of the nfection,complication,
fatigue etc.)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
with view of color images
Interventions/Control_2
without view of color images
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are diagnosed being as
hematopoietic neoplasms and agree to the
study
Key exclusion criteria
Patients who change for the worse
from the decision point
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yumi Saito |
Organization
Kyoto University
Division name
Human Health Science,Graduate School of Medicine
Zip code
Address
53 Kawaramachi, Syogoin Sakyo-ku, Kyoto-city
TEL
075-751-3920
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miho Okazaki |
Organization
Kyoto University
Division name
Human Health Science,Graduate School of Medicine
Zip code
Address
53 Kawaramachi, Syogoink Sakyo-ku, Kyoto-city
TEL
075-751-3920
Homepage URL
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Ministries and government offices
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
京都大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 01 | Month | 20 | 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
| 2011 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 01 | Month | 20 | Day |
Last modified on
| 2012 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005846
