Tokyo, Sept. 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062888) titled 'Maindofurunesu meisou de ketsueki touseki kanja no ketsuatsu o kusuri ni tayorazu kanri suru houhou ni tsuite no kousatsu' on Sept. 11.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Placebo
Primary Sponsor:
Institute - Oita University
Condition:
Condition - End-stage kidney failure (on dialysis)
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - In patients on maintenance hemodialysis, high blood pressure and blood pressure fluctuations during dialysis are often an issue, contributing to cardiovascular events and reduced quality of life. While managing with antihypertensive drugs and salt and fluid restrictions is important, there are limited non-drug options that patients can easily take on themselves. Mindfulness meditation has been reported to reduce stress and anxiety, lower sympathetic nervous activity, and help lower blood pressure, and it might be possible to do it during the waiting time before dialysis. This study explores the feasibility and potential effects on blood pressure stabilization of audio-guided mindfulness meditation in outpatient maintenance hemodialysis patients.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Mindfulness meditation
Interventions/Control_2 - White Noise
Eligibility:
Age-lower limit - 90
years-old
=
Gender - Male and Female
Key inclusion criteria - Patients receiving outpatient maintenance hemodialysis
Those who show a systolic blood pressure increase of 30 mmHg or more during dialysis, or have blood pressure instability such as hypotension during dialysis
Those who have the hearing and cognitive ability to listen to audio guidance and practice mindfulness meditation
Those who understand the study and can give written consent
Key exclusion criteria - People who have a history or current condition of mental disorders where symptoms like psychotic disorders, mania, or suicidal thoughts might worsen with mindfulness meditation.
People with severe cognitive or communication impairments.
People with hearing difficulties that make it hard to hear audio.
People who are expected to have major changes in dialysis conditions, blood pressure medications, or dry weight during the study period.
People whom the study supervisor deems inappropriate.
Target Size - 20
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=R000072007
Disclaimer: Curated by HT Syndication.
