UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060551 |
|---|---|
| Receipt number | R000069260 |
| Scientific Title | Effect of learning appropriate tourniquet pressure on peripheral vein dilation with a disposable tourniquet: A quasi-experimental pre-post study. |
| Date of disclosure of the study information | 2026/02/02 |
| Last modified on | 2026/02/02 14:07:21 |
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Basic information
Public title
Effect of learning appropriate tourniquet pressure on peripheral vein dilation with a disposable tourniquet.
Acronym
Effect of learning appropriate tourniquet pressure on peripheral vein dilation with a disposable tourniquet.
Scientific Title
Effect of learning appropriate tourniquet pressure on peripheral vein dilation with a disposable tourniquet: A quasi-experimental pre-post study.
Scientific Title:Acronym
Effect of learning appropriate tourniquet pressure on peripheral vein dilation with a disposable tourniquet: A quasi-experimental pre-post study.
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of learning appropriate tourniquet pressure on peripheral vein dilation when using a disposable tourniquet.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Vein cross-sectional area at 30 seconds after tourniquet application
Key secondary outcomes
1. Participants' characteristics (Nurse role)
- Age
- Gender
- Academic year or years of nursing experience
- Previous experience with disposable tourniquet use
2. Participants' characteristics (Patient role)
- Age
- Gender
- Non-dominant hand
- Upper arm circumference
- Blood pressure
3. Vein dilation outcomes at 30 seconds after tourniquet application
- Vein palpation score
- Vein depth
4. Subjective assessments (patient role) at 30 seconds after tourniquet application
- Subjective tightening feeling
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
A single educational intervention on appropriate tourniquet pressure will be conducted.
The intervention consists of an explanation of appropriate tourniquet pressure and application techniques, followed by five practice trials in which participants learn to acquire an appropriate tourniquet pressure by sensory perception, such as the feeling of tightening and tactile feedback, while referring to the scale markings as a reference.
The duration of the intervention is approximately 10 minutes, and it is conducted once on a single day during the study period.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Nurse-role participants:
- No history of allergy to metals or latex.
- No prior experience with a scale-marked tourniquet, either applying it or having it applied.
- Prior training in tourniquet application during the basic nursing education curriculum.
Patient-role participants:
- No underlying medical conditions.
- No history of surgery or range-of-motion limitation in the non-dominant shoulder/upper limb.
- No history of allergy to metals or latex.
- Blood pressure: diastolic < 90 mmHg and systolic >= 70 mmHg.
Key exclusion criteria
Inability to provide informed consent.
Poor physical condition on the day of the experiment (e.g., fever, feeling unwell).
Pain, physical discomfort, or other physical symptoms during the experiment.
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Riho |
| Middle name | |
| Last name | Tsuchiya |
Organization
Tokyo Healthcare University
Division name
Graduate school of Nursing
Zip code
152-8558
Address
2-5-1 Higashigaoka, Meguro, Tokyo
TEL
03-5779-5031
kg025009@thcu.ac.jp
Public contact
Name of contact person
| 1st name | Riho |
| Middle name | |
| Last name | Tsuchiya |
Organization
Tokyo Healthcare University
Division name
Graduate school of Nursing
Zip code
152-8558
Address
2-5-1 Higashigaoka, Meguro, Tokyo
TEL
03-5779-5031
Homepage URL
kg025009@thcu.ac.jp
Sponsor or person
Institute
Tokyo Healthcare University
Institute
Department
Personal name
Riho Tsuchiya
Funding Source
Organization
Tokyo Healthcare University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethical Review Board for Human-related Research, Tokyo Healthcare University
Address
4-1-17 Higashigotanda, Shinagawa, Tokyo
Tel
03-5721-7655
rinri @thcu.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
東京医療保健大学 国立病院機構キャンパス（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 05 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 02 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 02 | Month | 02 | Day |
Last modified on
| 2026 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069260
