UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062612 |
|---|---|
| Receipt number | R000071676 |
| Scientific Title | Effect of music on pain and anxiety during central venous port placement: a prospective randomized controlled trial |
| Date of disclosure of the study information | 2026/09/01 |
| Last modified on | 2026/09/24 15:41:24 |
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Basic information
Public title
Effect of music on pain and anxiety during central venous port placement: a randomized controlled trial
Acronym
MUSIC-PORT trial
Scientific Title
Effect of music on pain and anxiety during central venous port placement: a prospective randomized controlled trial
Scientific Title:Acronym
MUSIC-PORT trial
Region
| Japan |
Condition
Condition
Patients undergoing central venous port placement
Classification by specialty
| Surgery in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Between-group difference in pain during central venous port placement, assessed immediately after the procedure using the Visual Analog Scale (VAS).
Key secondary outcomes
Change in anxiety scores before and after central venous port placement, assessed using the State-Trait Anxiety Inventory (STAI).
Changes in vital signs (heart rate and blood pressure) during central venous port placement.
Patient satisfaction assessed immediately after central venous port placement using a questionnaire and Visual Analog Scale (VAS).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are 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
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.
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
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 sample size
390
Research contact person
Name of lead principal investigator
| 1st name | Tadaaki |
| Middle name | |
| Last name | Shimizu |
Organization
Department of Surgery, Shinshu University School of Medicine
Division name
Division of Gastroenterological, Hepato-Biliary-Pancreatic, Transplantation and Pediatric Surgery
Zip code
390-0821
Address
3-1-1 Asahi, Matsumoto, Nagano 390-8621, Japan
TEL
0263-35-4600
tadaaki@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Tadaaki |
| Middle name | |
| Last name | Shimizu |
Organization
Department of Surgery, Shinshu University School of Medicine
Division name
Division of Gastroenterological, Hepato-Biliary-Pancreatic, Transplantation and Pediatric Surgery
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano 390-8621, Japan
TEL
0263-37-2654
Homepage URL
surgery1@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Ethics Committee for Medical and Health Research, Shinshu University School of Medicine
Address
3-1-1 Asahi, Matsumoto, Nagano, Japan
Tel
0263-37-3099
mdrinri@shinshu-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 | 01 | 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
| 2026 | Year | 08 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2032 | Year | 03 | 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
| 2026 | Year | 08 | Month | 19 | Day |
Last modified on
| 2026 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071676
