Arteriovenous Fistula DysfunctionNCT07766525
Complementary Music Therapy for Pain During Percutaneous Transluminal Angioplasty.
A study testing Complementary Music Therapy in people with Arteriovenous Fistula Dysfunction, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This study evaluated the effectiveness of complementary music therapy in reducing pain among hemodialysis patients undergoing percutaneous transluminal angioplasty (PTA) for arteriovenous fistula dysfunction. Participants were assigned to either a music intervention group or a control group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arteriovenous Fistula Dysfunction
- What is being tested?
- Complementary Music Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Feb 2025to 24 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled to undergo percutaneous transluminal angioplasty (PTA) under local anesthesia.
- Adults aged 18 years or older who are willing to participate and provide written informed consent.
Who cannot join
- Patients with impaired consciousness or inability to express their pain perception.
- Patients requiring additional anesthesia or sedation during the procedure due to their clinical condition.
- Patients with hearing impairment or who use hearing aids.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Complementary Music Therapy on Intraoperative Pain Reduction for Patients Undergoing Percutaneous Transluminal Angioplasty.
This study evaluated the effectiveness of complementary music therapy in reducing pain among hemodialysis patients undergoing percutaneous transluminal angioplasty (PTA) for arteriovenous fistula dysfunction. Participants were assigned to either a music intervention group or a control group. The intervention group listened to self-selected music during the procedure, while the control group received routine care without music. Pain intensity and physiological parameters, including heart rate, respiratory rate, and blood pressure, were assessed to determine the effects of complementary music therapy during PTA.
- Conditions
- Arteriovenous Fistula Dysfunction
- Being tested
- Complementary Music Therapy
- Keywords
- music therapy, percutaneous transluminal angioplasty, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complementary Music TherapyBehavioural
Participants listened to self-selected music at 60-80 beats per minute through over-ear headphones from the beginning to the end of the PTA procedure, in addition to routine care.
| Study group | Role | What they receive |
|---|---|---|
| Complementary Music Therapy Group | Experimental | Participants received complementary music therapy during the PTA procedure in addition to routine care. Participants listened to self-selected music at 60-80 beats per minute through over-ear headphones from the beginning to the end of the procedure. Receives: Behavioral: Complementary Music Therapy |
| Routine Care Group | No intervention | Participants received routine care during the PTA procedure without complementary music therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Measured by the Visual Analog Scale (VAS)
Pain intensity was assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, with higher scores indicating greater pain intensity. Pain was assessed during balloon inflation throughout the PTA procedure.
Measured: During the PTA procedure, at up to five balloon inflation time points.
Pain Intensity Measured by the Numeric Rating Scale (NRS)
Pain intensity was assessed using the Numeric Rating Scale (NRS), ranging from 0 to 10, with higher scores indicating greater pain intensity. After the PTA procedure, participants rated their current pain intensity and retrospectively rated the most and least pain experienced during the procedure.
Measured: Immediately after completion of the PTA procedure.
Secondary outcomes (4)
Heart Rate During the PTA Procedure
Heart rate was measured in beats per minute (bpm) before, during, and after the PTA procedure. During the procedure, measurements were recorded at up to five balloon inflation time points.
Measured: Before, during, and immediately after the PTA procedure.
Respiratory Rate During the PTA Procedure
Respiratory rate was measured in breaths per minute before, during, and after the PTA procedure. During the procedure, measurements were recorded at up to five balloon inflation time points.
Measured: Before, during, and immediately after the PTA procedure.
Systolic Blood Pressure During the PTA Procedure
Systolic blood pressure was measured in mmHg before, during, and after the PTA procedure. During the procedure, measurements were recorded at up to five balloon inflation time points.
Measured: Before, during, and immediately after the PTA procedure.
Diastolic Blood Pressure During the PTA Procedure
Diastolic blood pressure was measured in mmHg before, during, and after the PTA procedure. During the procedure, measurements were recorded at up to five balloon inflation time points.
Measured: Before, during, and immediately after the PTA procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start24 Feb 2025
- Primary completion24 Nov 2025
- Study completion24 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteriovenous Fistula DysfunctionStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07766525
- Sponsor's protocol ID
- 202402308B0D0001
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to participant privacy and confidentiality considerations.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Complementary Music Therapy on Intraoperative Pain Reduction for Patients Undergoing Percutaneous Transluminal Angioplasty.
- ClinicalTrials.gov ID
- NCT07766525
- Acronym / sponsor ID
- 202402308B0D0001
- Conditions
- Arteriovenous Fistula Dysfunction
- Keywords
- music therapy, percutaneous transluminal angioplasty, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 24 Nov 2025 (actual)
- Study completion
- 24 Nov 2025 (actual)
- First posted
- 14 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluated the effectiveness of complementary music therapy in reducing pain among hemodialysis patients undergoing percutaneous transluminal angioplasty (PTA) for arteriovenous fistula dysfunction. Participants were assigned to either a music intervention group or a control group. The intervention group listened to self-selected music during the procedure, while the control group received routine care without music. Pain intensity and physiological parameters, including heart rate, respiratory rate, and blood pressure, were assessed to determine the effects of complementary music therapy during PTA.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complementary Music Therapy Group | Experimental | Behavioral: Complementary Music TherapyParticipants received complementary music therapy during the PTA procedure in addition to routine care. Participants listened to self-selected music at 60-80 beats per minute through over-ear headphones from the beginning to the end of the procedure. |
| Routine Care Group | No intervention | –Participants received routine care during the PTA procedure without complementary music therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled to undergo percutaneous transluminal angioplasty (PTA) under local anesthesia.
- Adults aged 18 years or older who are willing to participate and provide written informed consent.
Key exclusion criteria (3 listed)
- Patients with impaired consciousness or inability to express their pain perception.
- Patients requiring additional anesthesia or sedation during the procedure due to their clinical condition.
- Patients with hearing impairment or who use hearing aids.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complementary Music TherapyParticipants listened to self-selected music at 60-80 beats per minute through over-ear headphones from the beginning to the end of the PTA procedure, in addition to routine care. | Behavioural | Complementary Music Therapy Group |
Primary outcome
Pain Intensity Measured by the Visual Analog Scale (VAS)
Time frame: During the PTA procedure, at up to five balloon inflation time points.
Pain intensity was assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, with higher scores indicating greater pain intensity. Pain was assessed during balloon inflation throughout the PTA procedure.
Pain Intensity Measured by the Numeric Rating Scale (NRS)
Time frame: Immediately after completion of the PTA procedure.
Pain intensity was assessed using the Numeric Rating Scale (NRS), ranging from 0 to 10, with higher scores indicating greater pain intensity. After the PTA procedure, participants rated their current pain intensity and retrospectively rated the most and least pain experienced during the procedure.
4 secondary outcomes
Heart Rate During the PTA Procedure
Time frame: Before, during, and immediately after the PTA procedure.
Respiratory Rate During the PTA Procedure
Time frame: Before, during, and immediately after the PTA procedure.
Systolic Blood Pressure During the PTA Procedure
Time frame: Before, during, and immediately after the PTA procedure.
Diastolic Blood Pressure During the PTA Procedure
Time frame: Before, during, and immediately after the PTA procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to participant privacy and confidentiality considerations.
Related trials for Arteriovenous Fistula Dysfunction
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Active, not recruiting
SelfWrap-Assisted Arteriovenous Fistulas
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complementary Music Therapy in people with Arteriovenous Fistula Dysfunction, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity Measured by the Visual Analog Scale (VAS) (time frame: During the PTA procedure, at up to five balloon inflation time points.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.