Tokyo, Aug. 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058855) titled 'A study to investigate whether natural sounds such as birdsong alleviate anxiety and pain associated with percutaneous vascular access angioplasty' on Aug. 22.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Placebo
Primary Sponsor:
Institute - Akane Medical Corporation Tsuchiya General Hospital
Condition:
Condition - vascular access failure
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
Interventions/Control_1 - Natural sounds
Interventions/Control_2 - No natural sounds
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 Size - 22
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067298
Disclaimer: Curated by HT Syndication.