UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046869 |
|---|---|
| Receipt number | R000053435 |
| Scientific Title | A randomized controlled trial on the effectiveness of active warming on preoperative patients before cardiovascular catheterization and intervention |
| Date of disclosure of the study information | 2022/02/08 |
| Last modified on | 2022/08/09 13:39:58 |
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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
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
noritana@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
University of Shizuoka, School of Nursing
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053435
