UMIN-CTR Clinical Trial

Basic information
Public title	A randomized controlled trial on the effectiveness of active warming on preoperative patients before cardiovascular catheterization and intervention
Acronym	A randomized controlled trial on the effectiveness of active warming on preoperative patients before cardiovascular catheterization and intervention
Scientific Title	A randomized controlled trial on the effectiveness of active warming on preoperative patients before cardiovascular catheterization and intervention
Scientific Title:Acronym	A randomized controlled trial on the effectiveness of active warming on preoperative patients before cardiovascular catheterization and intervention
Region	Japan

Condition
Condition	Patients undergoing cardiovascular catheterization and intervention
Classification by specialty	Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We aimed to test a hypothesis that preoperative active warming reduces anxiety.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Anxiety will obtain the measurement before and after active warming.
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Patients in the intervention group were wearing active warming vests.
Interventions/Control_2	Patients in the control group were wearing non-active warming vests.
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	The inclusion criteria are patients undergoing cardiovascular catheterization and intervention.
Key exclusion criteria	Exclusion criteria are: emergency cardiovascular catheterization and intervention , patients implanted with internal cardiac pacemakers, patients with a diagnosis of cognitive impairment.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Noriyoshi Middle name Last name Tanaka
Organization	University of Shizuoka
Division name	School of Nursing
Zip code	422-8021
Address	2-2-1 Oshika, Suruga-ku, Shizuoka
TEL	054-202-2944
Email	noritana@u-shizuoka-ken.ac.jp

Public contact
Name of contact person	1st name Noriyoshi Middle name Last name Tanaka
Organization	University of Shizuoka
Division name	School of Nursing
Zip code	422-8021
Address	2-2-1 Oshika, Suruga-ku, Shizuoka
TEL	054-202-2944
Homepage URL
Email	noritana@u-shizuoka-ken.ac.jp

Sponsor
Institute	University of Shizuoka, School of Nursing
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Okamura Memorial Hospital Institutional Review Board
Address	293-1 Kakita Shimizu-cho, Sunto-gun, Shizuoka
Tel	055-973-3221
Email	yokoyama@okamura.or.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	岡村記念病院（静岡県）

Other administrative information
Date of disclosure of the study information	2022 Year 02 Month 08 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	100
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	2022 Year 02 Month 07 Day
Date of IRB	2022 Year 02 Month 07 Day
Anticipated trial start date	2022 Year 02 Month 07 Day
Last follow-up date	2022 Year 04 Month 08 Day
Date of closure to data entry	2022 Year 04 Month 08 Day
Date trial data considered complete	2022 Year 04 Month 08 Day
Date analysis concluded	2023 Year 01 Month 31 Day

Other
Other related information

Management information
Registered date	2022 Year 02 Month 08 Day
Last modified on	2022 Year 08 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053435