UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057820 |
|---|---|
| Receipt number | R000066093 |
| Scientific Title | A study of the effects of learning about intraoperative hypotension on the psychological state of anesthesiologists and their practice of anesthesia management. |
| Date of disclosure of the study information | 2025/05/10 |
| Last modified on | 2025/05/09 18:59:12 |
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Basic information
Public title
A study of the effects of learning about intraoperative hypotension on the psychological state of anesthesiologists and their practice of anesthesia management.
Acronym
A study of the effects of learning about intraoperative hypotension on the psychological state of anesthesiologists and their practice of anesthesia management.
Scientific Title
A study of the effects of learning about intraoperative hypotension on the psychological state of anesthesiologists and their practice of anesthesia management.
Scientific Title:Acronym
A study of the effects of learning about intraoperative hypotension on the psychological state of anesthesiologists and their practice of anesthesia management.
Region
| Japan |
Condition
Condition
All patients undergoing surgery at Yamagata University Hospital, anesthesiologists working at the hospital
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The three main objectives of this study are
1) To evaluate the effects of learning about intraoperative hypotension on the psychological state of anesthesiologists.
To evaluate changes in the psychological state of anesthesiologists before and after learning about intraoperative hypotension by means of a questionnaire survey. Specifically, we will examine changes in psychological factors such as anxiety, confidence, and knowledge level regarding hypotension. 2.
(2) To examine the effects of learning about intraoperative hypotension on anesthesia management practice
Changes in anesthesia management practices before and after learning about intraoperative hypotension will be evaluated by a retrospective chart survey of anesthesiologists. Specifically, the study will examine changes in management practices, such as prevention of hypotension, monitoring methods, and selection of therapeutic interventions. 3.
3. explore the relationship between psychological status and anesthesia management practices
Basic objectives2
Others
Basic objectives -Others
We will statistically analyze the association between changes in psychological state caused by learning about intraoperative hypotension and changes in anesthesia management practices. This will allow us to determine how anesthesiologists' psychological factors influence the management of intraoperative hypotension.
By achieving these objectives, we aim to evaluate the impact of learning about intraoperative hypotension on anesthesiologists' psychological status and anesthesia management practices from multiple perspectives, and to gain knowledge that will be useful in developing more effective educational programs and providing safe, high-quality anesthesia management.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint of the study will be the change in anesthesiologists' confidence in the management of intraoperative hypotension, as measured by a questionnaire confidence scale, from baseline to post-intervention assessment.
The questionnaire confidence scale was designed specifically for this study and will assess anesthesiologists' confidence in various aspects of intraoperative hypotension management, including
Recognizing risk factors and conditions that predispose to intraoperative hypotension.
Implementing appropriate preventive strategies to minimize the occurrence of intraoperative hypotension.
Selecting and applying appropriate monitoring methods to promptly detect intraoperative hypotension.
Initiation of timely and effective therapeutic interventions to manage intraoperative hypotensive episodes.
Confidence measures will be administered at baseline (before the educational intervention) and post-intervention (after completion of the educational program). The change in confidence score from baseline to post-intervention will be calculated for each participant.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
educational interventions:
Develop a comprehensive educational program on intraoperative hypotension, covering topics such as pathophysiology, risk factors, prevention strategies, monitoring methods, and therapeutic interventions.
Deliver the educational program to participants through lectures, workshops, and hands-on training sessions.
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients undergoing surgery at Yamagata University Hospital, anesthesiologists working at the hospital
Key exclusion criteria
Anesthesiologists who anticipate significant time constraints or extended absences during the study period, such as planning an extended vacation or job change, will be excluded.
Any refusal to complete the questionnaire will be excluded.
Target sample size
6020
Research contact person
Name of lead principal investigator
| 1st name | kenya |
| Middle name | |
| Last name | yarimizu |
Organization
Yamagata University School of Medicine
Division name
Department of Anesthesiology
Zip code
9909585
Address
2-2-2, Iida-Nishi, Yamagata City, Yamagata Prefecture
TEL
0236285400
yarimizu.kenya@gmail.com
Public contact
Name of contact person
| 1st name | kenya |
| Middle name | |
| Last name | yarimizu |
Organization
Yamagata University School of Medicine
Division name
Department of Anesthesiology
Zip code
9909585
Address
2-2-2, Iida-Nishi, Yamagata City, Yamagata Prefecture
TEL
0236285400
Homepage URL
yarimizu.kenya@gmail.com
Sponsor or person
Institute
Yamagata University
Institute
Department
Personal name
Funding Source
Organization
Edwards Lifesciences
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamagata University School of Medicine
Address
2-2-2, Iida-Nishi, Yamagata City, Yamagata Prefecture
Tel
0236285400
yarimizu.kenya@gmail.com
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
| 2025 | Year | 05 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 10 | 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
| 2025 | Year | 05 | Month | 09 | Day |
Last modified on
| 2025 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066093
