UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061164 |
|---|---|
| Receipt number | R000069007 |
| Scientific Title | Implementation and operational evaluation of an ICT-based provider-to-provider remote clinical support system for labor analgesia: an observational study |
| Date of disclosure of the study information | 2026/04/20 |
| Last modified on | 2026/04/05 20:41:24 |
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Basic information
Public title
Evaluation of an ICT-based provider-to-provider remote clinical support system for labor analgesia
Acronym
LARCS study
Scientific Title
Implementation and operational evaluation of an ICT-based provider-to-provider remote clinical support system for labor analgesia: an observational study
Scientific Title:Acronym
LARCS study
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the usefulness of implementing a healthcare provider-to-provider remote clinical support system using telecommunication technologies for labor analgesia conducted during weekday off-hours, in which obstetric anesthesiologists provide support for labor analgesia management from outside the hospital. The study population includes healthcare professionals and patients involved in labor analgesia management under the remote support system during off-hours. The primary outcomes are the success rate of establishing remote support and the perceived usefulness of remote support as assessed by questionnaire surveys administered to healthcare professionals. Through this study, we aim to obtain insights that may contribute to reducing the workload burden of anesthesiologists during off-hours and improving the efficiency of labor analgesia management systems.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Healthcare professionals involved in the remote clinical support system (midwives, obstetricians, and anesthesiologists) will complete a questionnaire using a five-point Likert scale and free-text responses to evaluate satisfaction with the communication application, perceived usefulness and safety of the remote clinical support system, improvements in interprofessional communication, intention for continued use, and operational challenges.
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthcare professionals (midwives, anesthesiologists, and obstetricians) involved in cases of labor analgesia management conducted under the remote support system during weekday off-hours.
Individuals who received an explanation of the purpose of this study and the questionnaire survey from the principal investigator, fully understood the explanation, and provided informed consent to participate in the study.
Key exclusion criteria
Individuals involved in cases in which remote support was not implemented at any time due to communication failures or other technical problems.
Individuals involved in cases in which labor progressed rapidly after the initiation of anesthesia and delivery was completed within a short period without any remote support.
Individuals who declined participation in this study.
Individuals deemed inappropriate for inclusion as study participants by the principal investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | MICHIKO |
| Middle name | |
| Last name | KANAZAWA |
Organization
Kansai Medical University
Division name
Department of Anesthesiology
Zip code
573-1010
Address
2-5-1 Shinmachi, Hirakata City, Osaka, Japan
TEL
072-804-0101
kanazawa.mic@kmu.ac.jp
Public contact
Name of contact person
| 1st name | MICHIKO |
| Middle name | |
| Last name | KANAZAWA |
Organization
Kansai Medical University
Division name
Department of Anesthesiology
Zip code
573-1010
Address
2-5-1 Shinmachi, Hirakata City, Osaka, Japan
TEL
09071119466
Homepage URL
kanazawa.mic@kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical University
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
Kansai Medical University
Address
2-5-1 Shinmachi, Hirakata City, Osaka, Japan
Tel
072-804-0101
kanazawa.mic@kmu.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
| 2026 | Year | 04 | Month | 20 | 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
| 2026 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is not an interventional study evaluating a new treatment or device, but an observational study assessing the operational performance and perceived usefulness of a remote support system implemented in routine clinical practice.
Management information
Registered date
| 2026 | Year | 04 | Month | 05 | Day |
Last modified on
| 2026 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069007
