UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058855 |
|---|---|
| Receipt number | R000067298 |
| Scientific Title | Effect of natural sounds on anxiety and pain during percutaneous transluminal angioplasty for hemodialysis vascular access: A crossover study |
| Date of disclosure of the study information | 2025/08/22 |
| Last modified on | 2025/08/21 09:15:58 |
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Basic information
Public title
A study to investigate whether natural sounds such as birdsong alleviate anxiety and pain associated with percutaneous vascular access angioplasty
Acronym
The effect of natural sounds on anxiety and pain during percutaneous vascular access angioplasty
Scientific Title
Effect of natural sounds on anxiety and pain during percutaneous transluminal angioplasty for hemodialysis vascular access: A crossover study
Scientific Title:Acronym
Natural sounds and anxiety/pain during PTA in hemodialysis patients
Region
| Japan |
Condition
Condition
vascular access failure
Classification by specialty
| Nephrology | Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For patients undergoing hemodialysis, percutaneous vascular access angioplasty is frequently performed invasive procedures, and reducing anxiety and pain is important. Natural sounds (such as bird chirping) have the potential to alleviate mental tension during medical procedures, but studies in hemodialysis patients are limited. This study aims to evaluate whether listening to natural sounds during procedures reduces anxiety and pain using the numerical rating scale (NRS) and to clarify its efficacy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Anxiety before and after treatment (NRS), pain after treatment (NRS)
Key secondary outcomes
Changes in blood pressure, heart rate, and oxygen saturation
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
| Device,equipment |
Interventions/Control_1
Natural sounds
Interventions/Control_2
No natural sounds
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who are scheduled to undergo percutaneous transluminal vascular access angioplasty at our hospital two or more times.
Those who have obtained written consent.
Key exclusion criteria
Those who have difficulty expressing their intentions due to cognitive impairment, etc.
Those with severe hearing impairment.
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Sadanori |
| Middle name | |
| Last name | Shintaku |
Organization
Akane Medical Corporation Tsuchiya General Hospital
Division name
Department of kideny disease and blood purification therapy
Zip code
730-8655
Address
3-30 Nakajima-cho, Naka-ku, Hiroshima, Japan
TEL
082-243-9191
sada-shin50@m4.dion.ne.jp
Public contact
Name of contact person
| 1st name | Sadanori |
| Middle name | |
| Last name | Shintaku |
Organization
Akane Medical Corporation Tsuchiya General Hospital
Division name
Department of kideny disease and blood purification therapy
Zip code
730-8655
Address
3-30 Nakajima-cho, Naka-ku, Hiroshima, Japan
TEL
082-243-9191
Homepage URL
sada-shin50@m4.dion.ne.jp
Sponsor or person
Institute
Akane Medical Corporation Tsuchiya General Hospital
Institute
Department
Personal name
Sadanori Shintaku
Funding Source
Organization
self-supply
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical trials and ethics review committee
Address
3-30 Nakajima-cho, Naka-ku, Hiroshima, Japan
Tel
082-243-9191
postmaster@tsuchiya-hp.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
| 2025 | Year | 08 | Month | 22 | 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
| 2025 | Year | 07 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 22 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 08 | Month | 21 | Day |
Last modified on
| 2025 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067298
