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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029103
Receipt No. 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

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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
Email 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
Email ehoshina@cc.okayama-u.ac.jp

Sponsor
Institute Okayama University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033041

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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