UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029103 |
|---|---|
| Receipt number | R000033041 |
| Scientific Title | Evaluation of temperature sense with heat keeping by electric blanket after cryoablation for renal tumor. -Comparisom between the nomal bed group and the heat keeping group right after returning to the room- |
| Date of disclosure of the study information | 2017/10/20 |
| Last modified on | 2017/09/12 10:10:01 |
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Basic information
Public title
Evaluation of temperature sense with heat keeping by electric blanket after cryoablation for renal tumor. -Comparisom between the nomal bed group and the heat keeping group right after returning to the room-
Acronym
Evaluation of temperature sense with heat keeping by electric blanket after cryoablation for renal tumor. -Comparisom between the nomal bed group and the heat keeping group right after returning to the room-
Scientific Title
Evaluation of temperature sense with heat keeping by electric blanket after cryoablation for renal tumor. -Comparisom between the nomal bed group and the heat keeping group right after returning to the room-
Scientific Title:Acronym
Evaluation of temperature sense with heat keeping by electric blanket after cryoablation for renal tumor. -Comparisom between the nomal bed group and the heat keeping group right after returning to the room-
Region
| Japan |
Condition
Condition
kidney cancer
Classification by specialty
| Radiology | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effectiveness of using an electric blanket after kidney cryo abulation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
temperature sense of Hought and Yaglou
Key secondary outcomes
axillary temperature,with or without of shivering,peripheral coldness,body height and weight,body-mass index (BMI),with or without of renal arterial embolization,size of tumor,time of procedure,time of stay in the operating room,temperature and humidity of the operating room,temperature and humidity of the hospital ward,temperature inside the bed
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are 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
| Other |
Interventions/Control_1
not use elctric blanket after returning to the room
Interventions/Control_2
use elctric blanket after returning to the room
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
1.Patients who are receiving cryotherapy in the radiological ward, okayama university hospital, between October 20, 2017 and April 20, 2019.
2.Patients who have the ability to provide informed consent.
3.Patients aged 20 years old and above.
Key exclusion criteria
1.Cognitive decline.
2.Disturbance of perception.
3.Patients weighing more than 100Kg
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiko Hoshina |
Organization
Okayama University Hospital
Division name
Center of Active Reserch and Education for Nurses
Zip code
Address
2-5-1, Shikata-cho,Kita-ku,Okayama City,Okayama
TEL
086-235-6090
ehoshina@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiko Hoshina |
Organization
Okayama University Hospital
Division name
Center of Active Reserch and Education for Nurses
Zip code
Address
2-5-1, Shikata-cho,Kita-ku,Okayama City,Okayama
TEL
086-235-6090
Homepage URL
ehoshina@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Okayama University
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
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 10 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 21 | Day |
Date of closure to data entry
| 2019 | Year | 04 | Month | 22 | Day |
Date trial data considered complete
| 2019 | Year | 04 | Month | 25 | Day |
Date analysis concluded
| 2019 | Year | 10 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 12 | Day |
Last modified on
| 2017 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033041
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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