UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055176 |
|---|---|
| Receipt number | R000063043 |
| Scientific Title | Effect of attenuating puncture pain by iced water in hemodialysis patient with using local anesthesia. |
| Date of disclosure of the study information | 2024/08/06 |
| Last modified on | 2024/08/06 18:00:45 |
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Basic information
Public title
Effect of attenuating puncture pain by iced water in hemodialysis patient with using local anesthesia.
Acronym
Additional effect of attenuating puncture pain by iced water upon local anesthesia.
Scientific Title
Effect of attenuating puncture pain by iced water in hemodialysis patient with using local anesthesia.
Scientific Title:Acronym
Additional effect of attenuating puncture pain by iced water upon local anesthesia.
Region
| Japan |
Condition
Condition
hemodialysis patients
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We elucidate the additional effect of attenuating puncture pain by iced water in hemodialysis patients with local anesthesia tape.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cross-over analysis of treatment effects(visual analog scale(VAS)) is evaluated between ice water group and control group.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
iced water cooling
Interventions/Control_2
control
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Those who undergo hemodialysis over 90 days.
2.Those who use local anesthesia tape for puncture pain.
Key exclusion criteria
1.Those who have dementia.
2.Those who have so sensitive skin that iced water cooling is not recommended.
3.Those with sensory disturbance in upper limbs.
4.Those whom responsible doctors consider as inappropriate participants
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Okamura |
Organization
Ishikiri Seiki Hospital
Division name
Department of Dialysis
Zip code
579-8026
Address
18-28, Yayoi-cho, Higashiosaka-city, Osaka, Japan
TEL
072-988-3121
y-tateishi@ishikiriseiki.or.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Tateishi |
Organization
Ishikiri Seiki Hospital
Division name
Department of Dialysis
Zip code
579-8026
Address
18-28, Yayoi-cho, Higasiosaka-city, Osaka, Japan
TEL
072-988-3121
Homepage URL
y-tateishi@ishikiriseiki.or.jp
Sponsor or person
Institute
Ishikiri Seiki Hospital
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Ethics committee in Ishikiri Seiki Hospital
Address
18-28, Yayoi-cho, Higasiosaka-city, Osaka, Japan
Tel
072-988-3121
y-tateishi@ishikiriseiki.or.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 | 08 | Month | 06 | 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
| 2024 | Year | 06 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 08 | Month | 07 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 06 | Day |
Last modified on
| 2024 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063043
