UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055431 |
|---|---|
| Receipt number | R000062814 |
| Scientific Title | Characteristics of Eye Movement During Perineal Protection Using a Phantom in Skilled Midwives and Novice Midwives |
| Date of disclosure of the study information | 2024/09/05 |
| Last modified on | 2025/03/03 15:14:09 |
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Basic information
Public title
Characteristics of Eye Movement During Perineal Protection Using a Phantom in Skilled Midwives and Novice Midwives
Acronym
Characteristics of Eye Movement During Perineal Protection Using a Phantom in Skilled Midwives and Novice Midwives
Scientific Title
Characteristics of Eye Movement During Perineal Protection Using a Phantom in Skilled Midwives and Novice Midwives
Scientific Title:Acronym
Characteristics of Eye Movement During Perineal Protection Using a Phantom in Skilled Midwives and Novice Midwives
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare eye movements and intentions during the implementation of perineal protection in skilled midwives and novice midwives using a simulation that simulates practice.
Basic objectives2
Others
Basic objectives -Others
The purpose of the study is to identify the characteristics of the gaze of skilled midwives and novice midwives.
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gaze Behavior (gaze trajectory, gazing time by region, number of gazes by region)
Key secondary outcomes
Intent of eye movement
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 22 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Midwives who have assisted in at least 100 deliveries, midwifery students enrolled in midwifery training programs, and new midwives who have assisted in less than 10 deliveries since joining the profession.
Experienced midwives who have experience in teaching delivery assistance in a phantom.
Key exclusion criteria
Those who wear glasses during labor and delivery
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hisayo |
| Middle name | |
| Last name | Okayama |
Organization
University of Tsukuba
Division name
Institute of Medicine
Zip code
305-8577
Address
1-1-1 Tennodai, Tsukuba City, Ibaraki Prefecture
TEL
029-853-8572
okayama@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Nagata |
Organization
Graduate School of Comprehensive Human Science, University of Tsukuba, Tsukuba, Ibaraki, Japan
Division name
Graduate Programs in Nursing Science, Degree Programs in Comprehensive Human Sciences
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba City, Ibaraki Prefecture
TEL
029-853-8572
Homepage URL
s2321383@u.tsukuba.ac.jp
Sponsor or person
Institute
Others
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
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
Graduate Programs in Nursing Science, Degree Programs in Comprehensive Human Sciences, Graduate School of Comprehensive Human Science, University of Tsukuba, Tsukuba, Ibaraki, Japan
Address
1-1-1 Tennodai, Tsukuba City, Ibaraki Prefecture
Tel
029-853-8572
s2321383@u.tsukuba.ac.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 05 | 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
19
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
| 2024 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 28 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
After recruiting the target population, a screening survey will be conducted using a questionnaire form to obtain responses regarding basic attributes. Based on the screening survey responses, we will check whether the inclusion and exclusion criteria are met. We will send an e-mail to those who responded to the screening survey asking whether or not they wish to participate in the experiment. For those who informally agree to participate, we will provide a detailed explanation of the study and arrange a date for the individual experiment to be conducted. If consent is obtained, the subject is asked to fill out a consent form, and is informed that he/she can withdraw consent at any time before the end of the experiment. In the experiment, the gaze analysis device is explained according to the pamphlet. After the gaze analysis device is attached, calibration is performed to correct the error between the gazing point calculated from the positional relationship between the pupil and the corneal reflection image and the actual gazing point. After successful calibration, the items to be used, the location of the CTG monitor, and the display of the video of the birth mother are explained. After that, "Please assist with the delivery from the onset to the delivery of the head of the baby, just as you would in an actual delivery" is explained, and the measurement is performed.
After the eye movement measurement, the video taken by the eye movement analyzer is reviewed with the subject to clarify the intention of the eye movement during the measurement, and an interview is conducted.
Management information
Registered date
| 2024 | Year | 09 | Month | 05 | Day |
Last modified on
| 2025 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062814
