Clinical Trial: Effect of music on pain and anxiety during central venous port placement: protocol for a prospective randomized controlled trial (Japan)

Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062612) titled 'Effect of music on pain and anxiety during central venous port placement: a randomized controlled trial' on Sept. 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - Placebo

Primary Sponsor: Institute - Shinshu University

Condition: Condition - Patients undergoing central venous port placement Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Central venous port placement is frequently performed in patients requiring cancer treatment or long-term venous access. As the procedure is commonly performed under local anesthesia, patients may experience pain and anxiety during the procedure. In recent years, music therapy has attracted attention as a safe and cost-effective adjunctive intervention for reducing pain and anxiety, and its effectiveness has been reported during procedures such as vascular access for hemodialysis, lumbar puncture, and cystoscopy. This randomized controlled trial aims to evaluate the effects of music therapy on pain and anxiety in patients undergoing central venous port placement, compared with a control group exposed to white noise. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Participants will listen to music through headphones or earphones during central venous port placement. Music will be played continuously from the start to the end of the procedure. Interventions/Control_2 - Participants will listen to white noise through headphones or earphones during central venous port placement. White noise will be played continuously from the start to the end of the procedure.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients undergoing central venous port placement. Male or female patients aged 18 years or older. Patients with adequate hearing ability who are able to receive an explanation of the central venous port placement procedure and personally provide written informed consent for the procedure. Patients who, after receiving sufficient information about the study, voluntarily provide written informed consent to participate in the study. Key exclusion criteria - Patients undergoing central venous port placement under general anesthesia. Patients who receive analgesics (e.g., acetaminophen, nonsteroidal anti-inflammatory drugs [NSAIDs], or opioid analgesics) on the day of central venous port placement. Patients with a history of congenital insensitivity to pain or other conditions associated with insensitivity to pain. Patients who are considered unsuitable for participation in the study by the principal investigator. Target Size - 390

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 19 Day Anticipated trial start date - 2026 Year 10 Month 01 Day Last follow-up date - 2032 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071676

Disclaimer: Curated by HT Syndication.