UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062888 |
|---|---|
| Receipt number | R000072007 |
| Scientific Title | Maindofurunesu meisou de ketsueki touseki kanja no ketsuatsu o kusuri ni tayorazu kanri suru houhou ni tsuite no kousatsu |
| Date of disclosure of the study information | 2026/09/11 |
| Last modified on | 2026/09/11 18:40:15 |
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Basic information
Public title
Maindofurunesu meisou de ketsueki touseki kanja no ketsuatsu o kusuri ni tayorazu kanri suru houhou ni tsuite no kousatsu
Acronym
Maindofurunesu meisou de ketsueki touseki kanja no ketsuatsu o kusuri ni tayorazu kanri suru houhou ni tsuite no kousatsu
Scientific Title
Maindofurunesu meisou de ketsueki touseki kanja no ketsuatsu o kusuri ni tayorazu kanri suru houhou ni tsuite no kousatsu
Scientific Title:Acronym
Maindofurunesu meisou de ketsueki touseki kanja no ketsuatsu o kusuri ni tayorazu kanri suru houhou ni tsuite no kousatsu
Region
| Japan |
Condition
Condition
End-stage kidney failure (on dialysis)
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
After obtaining consent and during the waiting time before starting dialysis, about 5 minutes of guided mindfulness meditation with an audio guide will be conducted in a quiet environment using headphones or speakers. The audio guide will focus on breathing and will not aim for religious proselytizing or promoting any particular ideology.
In the control condition, participants will listen to white noise for the same amount of time in the same environment. If possible, the mindfulness meditation condition and the control condition will be compared within the same participants.
Each condition will be conducted three times a week before dialysis, with a basic plan of about three total sessions. As needed, feasibility can be checked in healthy individuals or a small number of cases, and the intervention period and procedure can be adjusted accordingly.
Blood pressure and pulse before and after the intervention and during dialysis will be recorded within the range usually measured in routine care. In addition, increases in systolic blood pressure of 30 mmHg or more after the start of dialysis, hypotension during dialysis, symptoms, use of antihypertensive drugs, and dialysis conditions will be recorded.
As an outcome measure for the effect of mindfulness meditation, the STAI (state and trait anxiety) or Affect Grid will be used as much as possible to evaluate changes in anxiety and emotional states before and after the intervention.
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
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Mindfulness meditation
Interventions/Control_2
White Noise
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
| 90 | years-old | <= |
Age-upper 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 sample size
20
Research contact person
Name of lead principal investigator
| 1st name | takesi |
| Middle name | |
| Last name | nakata |
Organization
Oita University
Division name
Faculty of Welfare and Health Sciences, Physical Therapy Course
Zip code
870-1124
Address
700 Danno-hara, Oita City, Oita Prefecture
TEL
090-554-6613
nakata@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | takesi |
| Middle name | |
| Last name | nakata |
Organization
Oita University
Division name
Faculty of Welfare and Health Sciences, Physical Therapy Course
Zip code
870-1124
Address
700 Danno-hara, Oita City, Oita Prefecture
TEL
090-554-6613
Homepage URL
nakata@oita-u.ac.jp
Sponsor or person
Institute
Oita University
Institute
Department
Personal name
Funding Source
Organization
Oita University
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
Oita University
Address
700 Danno-hara, Oita City, Oita Prefecture
Tel
090-554-6613
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
Partially published
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=R000072007
