UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062889 |
|---|---|
| Receipt number | R000072008 |
| Scientific Title | Investigation of the Pain-Relieving Effects of a Hand-Gripping Task on Puncture-Related Pain in Patients Undergoing Maintenance Hemodialysis |
| Date of disclosure of the study information | 2026/09/11 |
| Last modified on | 2026/09/11 18:42:23 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Investigation of the Pain-Relieving Effects of a Hand-Gripping Task on Puncture-Related Pain in Patients Undergoing Maintenance Hemodialysis
Acronym
Investigation of the Pain-Relieving Effects of a Hand-Gripping Task on Puncture-Related Pain in Patients Undergoing Maintenance Hemodialysis
Scientific Title
Investigation of the Pain-Relieving Effects of a Hand-Gripping Task on Puncture-Related Pain in Patients Undergoing Maintenance Hemodialysis
Scientific Title:Acronym
Investigation of the Pain-Relieving Effects of a Hand-Gripping Task on Puncture-Related Pain in Patients Undergoing Maintenance Hemodialysis
Region
| Japan |
Condition
Condition
chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Hemodialysis requires treatment three times a week, with each session lasting approximately four hours. At the beginning of each treatment session, two needles are inserted: one for blood removal and the other for blood return. Dialysis needles are larger in diameter than conventional injection needles, and pain associated with needle insertion is an important issue that can negatively affect patients' quality of life. This study aims to investigate whether squeezing a stress ball during needle insertion can reduce pain. In particular, considering the aging of the hemodialysis population in Japan and the current use of analgesics prior to needle insertion, this study will exploratorily evaluate the effectiveness of this intervention in older patients who use analgesics.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual Analogue Scale
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
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
medium-hardness ball
Interventions/Control_2
hard-hardness ball
Interventions/Control_3
No intervention
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
| 65 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with stable maintenance hemodialysis who have been undergoing hemodialysis for at least 3 months and use an arteriovenous fistula or arteriovenous graft as vascular access
Patients receiving outpatient maintenance hemodialysis
Age 65 years or older
Patients with a VAS score of 1 or higher for pain during routine dialysis needle insertion
Patients who understand the study procedures and provide written informed consent
Key exclusion criteria
Patients with mental illness, cognitive impairment, or communication difficulties that interfere with their understanding of the study explanation or their ability to express their intentions
Patients with pain, paralysis, contractures, skin disorders, or other conditions affecting the hand or arm that may interfere with gripping the stress ball
Patients who have difficulty gripping the ball with the hand on the non-shunt side
Patients deemed unsuitable for participation by the principal investigator
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | Nakata Takesi |
| Middle name | |
| Last name | male |
Organization
Ooitadaigaku
Division name
fukusikennkoukagakubu
Zip code
870-1124
Address
ooitakennooitasidannnoharu700
TEL
097-554-6113
nakata@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Nakata Takesi |
| Middle name | |
| Last name | male |
Organization
ooitagaigaku
Division name
fukusikennkoukagakubu
Zip code
870-1124
Address
ooitakennooitasidannnoharu700
TEL
097-554-6113
Homepage URL
nakata@oita-u.ac.jp
Sponsor or person
Institute
ooitadaigaku
Institute
Department
Personal name
Funding Source
Organization
ooitadaigaku
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
ooitadaigaku
Address
ooitakennooitasidannnoharu700
Tel
097-554-6113
nakata@oita-u.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 | 09 | Month | 11 | 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 | 09 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 11 | Day |
Last modified on
| 2026 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072008
