UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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-
Title of the study (Brief 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-
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	Eiko Hoshina
Organization	Okayama University Hospital
Division name	Center of Active Reserch and Education for Nurses
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	Eiko Hoshina
Organization	Okayama University Hospital
Division name	Center of Active Reserch and Education for Nurses
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 10 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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