UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060101 |
|---|---|
| Receipt number | R000068738 |
| Scientific Title | Development and Evaluation of an Educational Support Program to Strengthen Nursing Perspectives in Peripherally Inserted Central Catheter Insertion by Nurse Practitioners |
| Date of disclosure of the study information | 2025/12/17 |
| Last modified on | 2025/12/17 00:45:18 |
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Basic information
Public title
Development and Evaluation of an Educational Support Program to Strengthen Nursing Perspectives in Peripherally Inserted Central Catheter Insertion by Nurse Practitioners
Acronym
NP-PICC Education Study
Scientific Title
Development and Evaluation of an Educational Support Program to Strengthen Nursing Perspectives in Peripherally Inserted Central Catheter Insertion by Nurse Practitioners
Scientific Title:Acronym
NP-PICC Education Study
Region
| Japan |
Condition
Condition
Not applicable (Educational intervention study for nurse practitioners)
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop an educational support program to strengthen nursing perspectives in peripherally inserted central catheter (PICC) insertion by nurse practitioners and to evaluate its feasibility and educational outcomes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in scores on the Nurse Problem-Solving Behavior Self-Evaluation Scale developed by Hattori et al., before and after implementation of the educational support program.
Key secondary outcomes
Changes in scores of self-assessment items related to nursing practices in PICC insertion, including pre-insertion explanation, support during insertion, post-insertion management education for nurses, and interprofessional collaboration.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Participants in the intervention group received an educational support program designed to strengthen nursing perspectives in peripherally inserted central catheter (PICC) insertion by nurse practitioners. The program consisted of lecture materials, video-based learning, and case discussions covering nursing practices before, during, and after PICC insertion.
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
| 20 | years-old | <= |
Age-upper limit
| 55 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Nurse practitioners currently working in a healthcare setting who have experience related to peripherally inserted central catheter (PICC) insertion. Participants who provided written informed consent after receiving an explanation of the study purpose and procedures.
Key exclusion criteria
Individuals who have no experience with peripherally inserted central catheter (PICC) insertion.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Mayumi |
| Middle name | |
| Last name | Sato |
Organization
Graduate School of Health and Welfare Sciences,International University of Health and Welfare
Division name
Department of Nursing
Zip code
107-8402
Address
4-1-26 Akasaka, Minato-ku, Tokyo 107-8402, Japan
TEL
08019236988
25u1628@g.iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Mayumi |
| Middle name | |
| Last name | Sato |
Organization
Graduate School of Health and Welfare Sciences, International University of Health and Welfare
Division name
Department of Nursing
Zip code
107-8402
Address
4-1-26 Akasaka, Minato-ku, Tokyo 107-8402, Japan
TEL
0355743900
Homepage URL
25u1628@g.iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
None
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
Institutional Review Board, International University of Health and Welfare
Address
4-1-26 Akasaka, Minato-ku, Tokyo 107-8402, Japan
Tel
03-5574-3900
rinri-tky@iuhw.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
| 2025 | Year | 12 | Month | 17 | 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 | 08 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 06 | 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
| 2025 | Year | 12 | Month | 17 | Day |
Last modified on
| 2025 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068738
