UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054618 |
|---|---|
| Receipt number | R000062403 |
| Scientific Title | Examination of cooling techniques for nurses during caesarean section surgery: A prospective intervention study |
| Date of disclosure of the study information | 2024/06/10 |
| Last modified on | 2024/06/10 16:43:13 |
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Basic information
Public title
Examination of cooling techniques for nurses during caesarean section surgery
Acronym
Examination of cooling techniques for nurses during caesarean section surgery
Scientific Title
Examination of cooling techniques for nurses during caesarean section surgery: A prospective intervention study
Scientific Title:Acronym
Examination of cooling techniques for nurses during caesarean section surgery
Region
| Japan |
Condition
Condition
Caesarean section
Classification by specialty
| Surgery in general | Obstetrics and Gynecology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
During caesarean section surgery, various measures are taken to keep the unborn fetus from getting cold. One of these efforts is to raise the operating room temperature. While this method is very effective for surgical purposes, it can be very stressful for operating room nurses, as they are required to work in a very hot operating room in addition to the tense surgical content. In addition, in recent years, in order to cut costs, surgical gowns made of thicker, reusable fabrics are often worn, making the heat even worse. In recent years, small cooling fans that can be worn under gowns have been developed and are said to be effective at construction sites and workplaces during the summer. The cooling fan is attached to the back and operated. This system uses evaporative heat to cool you down the more you sweat. We will conduct research to see if this can be applied to clinical situations.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Discomfort with heat during surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Setting the cooling fan
Interventions/Control_2
Placebo
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Nurse working in the operating room
Key exclusion criteria
Emergency surgery
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kojima |
| Middle name | |
| Last name | Yuki |
Organization
Asahi General Hospital
Division name
Anesthesiology
Zip code
2892511
Address
I-1326, Asahi city, Chiba.
TEL
0479638111
cojicoji1109@gmail.com
Public contact
Name of contact person
| 1st name | Kojima |
| Middle name | |
| Last name | Yuki |
Organization
Asahi General Hospital
Division name
Anesthesiology
Zip code
2892511
Address
I-1326, Asahi city, Chiba.
TEL
0479638111
Homepage URL
cojicoji1109@gmail.com
Sponsor or person
Institute
Asahi General Hospital
Institute
Department
Personal name
Funding Source
Organization
Asahi General Hospital
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
Asahi General Hospital
Address
I-1326, Asahi city, Chiba.
Tel
04796381111
cojicoji1109@gmail.com
Secondary IDs
Secondary IDs
YES
Study ID_1
2024052119
Org. issuing International ID_1
Asahi General Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 10 | 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
| 2024 | Year | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 10 | Day |
Last modified on
| 2024 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062403
