Tokyo, Sept. 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062889) titled 'Investigation of the Pain-Relieving Effects of a Hand-Gripping Task on Puncture-Related Pain in Patients Undergoing Maintenance Hemodialysis' on Sept. 11.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - ooitadaigaku
Condition:
Condition - chronic kidney disease
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
Interventions/Control_1 - medium-hardness ball
Interventions/Control_2 - hard-hardness ball
Eligibility:
Age-lower limit - 65
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 Size - 21
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 09 Month 11 Day
Anticipated trial start date - 2026 Year 09 Month 17 Day
Last follow-up date - 2026 Year 10 Month 17 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072008
Disclaimer: Curated by HT Syndication.
