Music-Assisted Acupressure for Pain During AVF Cannulation in Hemodialysis Patients (MUSIC-ACUP)

June 15, 2026 updated by: Gülsüm Gülşen

Effect of Music-Assisted Acupressure on Pain During Arteriovenous Fistula Cannulation in Hemodialysis Patients: A Randomized Controlled Trial

This randomized controlled trial was conducted to evaluate the effect of music-assisted acupressure on pain experienced during arteriovenous fistula (AVF) cannulation in hemodialysis patients. The study was carried out with 72 patients receiving hemodialysis treatment three times per week via AVF in a state hospital in Gaziantep, Türkiye.

Participants were randomly assigned to one of four groups: music-assisted acupressure, acupressure alone, music alone, and control group (routine care). The acupressure intervention was applied to the Hegu (LI4) point for approximately 3 minutes prior to needle insertion, while the music intervention consisted of listening to instrumental Classical Turkish Music in the Acemaşiran mode through headphones starting 5 minutes before cannulation and continuing until the end of the procedure.

Pain intensity during AVF cannulation was measured using the Visual Analog Scale (VAS) during three consecutive dialysis sessions. The primary outcome was pain severity during needle insertion. The study aimed to determine whether combining music therapy and acupressure would provide greater pain relief compared to single interventions or routine care.

Findings suggest that music-assisted acupressure may be an effective non-pharmacological nursing intervention for reducing procedural pain in hemodialysis patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study was designed as a randomized controlled trial to investigate the effect of music-assisted acupressure on procedural pain during arteriovenous fistula (AVF) cannulation in patients undergoing hemodialysis. The study was conducted between March and November 2024 in the hemodialysis unit of a state hospital in Gaziantep, Türkiye.

A total of 72 eligible patients receiving hemodialysis treatment via AVF were included. Patients were randomly assigned into four equal groups (n=18 per group): music-assisted acupressure, acupressure, music, and control. Randomization was performed using a simple lottery method. All AVF cannulation procedures were performed by the same experienced dialysis nurse to ensure procedural consistency.

The acupressure intervention was applied to the Hegu (LI4) point on the hand contralateral to the AVF site. Finger pressure was applied perpendicularly for approximately 3 minutes prior to needle insertion. The music intervention consisted of listening to instrumental Classical Turkish Music in the Acemaşiran mode through headphones, beginning 5 minutes before cannulation and continuing until the end of the procedure.

Participants in the combined intervention group received both acupressure and music simultaneously using the same protocols described above. The control group received routine hemodialysis care without additional intervention.

Pain intensity during AVF cannulation was assessed using the Visual Analog Scale (VAS, 0-10) immediately after each procedure. Measurements were repeated over three consecutive hemodialysis sessions. Sociodemographic and clinical data were also collected using a structured patient information form.

The primary outcome of the study was pain intensity during AVF cannulation. Data were analyzed using non-parametric statistical tests due to non-normal distribution, including Kruskal-Wallis, Friedman, and Brunner-Langer models for repeated measures. Statistical significance was set at p < 0.05.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Şahinbey
      • Gaziantep, Şahinbey, Turkey (Türkiye), 27470
        • Gaziantep Şehir Hastanesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Receiving hemodialysis treatment three times per week
  • Presence of an arteriovenous fistula (AVF) for vascular access
  • Ability to communicate in Turkish
  • No use of analgesic medication prior to AVF cannulation
  • No pain or pathology in the upper extremities that could affect intervention application or pain assessment
  • Willingness to participate in the study and provide informed consent

Exclusion Criteria:

  • Diagnosis of neuropathy
  • History of upper extremity surgery or soft tissue injury
  • Presence of bleeding disorders or coagulation disorders
  • Diagnosis of heart failure
  • Presence of a pacemaker
  • Inability to comply with study procedures or complete data collection
  • Any condition that could interfere with pain perception or the application of acupressure or music intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Music-Assisted Acupressure Group
Listening to instrumental Classical Turkish Music (Acemaşiran mode) via headphones starting 5 minutes before AVF cannulation and continuing throughout the procedure.
Other: Music-Assisted Acupressure
Combined application of acupressure at the Hegu (LI4) point for approximately 3 minutes together with simultaneous listening to instrumental Classical Turkish Music in the Acemaşiran mode starting 5 minutes before and continuing during AVF cannulation.
Other: Acupressure
Manual acupressure applied to the Hegu (LI4) point on the hand contralateral to the AVF site for approximately 3 minutes prior to AVF cannulation.
Other: Acupressure
Manual acupressure applied to the Hegu (LI4) point on the hand contralateral to the AVF site for approximately 3 minutes prior to AVF cannulation. Finger pressure was applied perpendicularly at a tolerable intensity to reduce procedural pain.
Other: Music Group
Participants listened to instrumental Classical Turkish Music in the Acemaşiran mode through headphones starting 5 minutes before AVF cannulation and continuing until the end of the procedure.
Other: Music Therapy
Listening to instrumental Classical Turkish Music in the Acemaşiran mode via headphones starting 5 minutes before arteriovenous fistula (AVF) cannulation and continuing until the end of the procedure. The aim is to reduce procedural pain by distraction and emotional regulation.
Other: Standard Care
Routine hemodialysis care without additional music or acupressure intervention during AVF cannulation.
Other: Standard Care
Routine hemodialysis care without any additional intervention during arteriovenous fistula (AVF) cannulation. Pain assessment was performed after the procedure using the Visual Analog Scale (VAS).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Intensity During AVF Cannulation (VAS Score)
Time Frame: During each hemodialysis session over 3 consecutive sessions (March-November 2024)
Pain intensity experienced during arteriovenous fistula (AVF) cannulation was assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Measurements were obtained immediately after each cannulation procedure across three consecutive hemodialysis sessions.
During each hemodialysis session over 3 consecutive sessions (March-November 2024)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Pain Scores Over Time
Time Frame: Baseline and across 3 consecutive hemodialysis sessions
Changes in pain intensity across repeated AVF cannulation procedures were evaluated to assess the consistency and trend of intervention effects over time among study groups.
Baseline and across 3 consecutive hemodialysis sessions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gülsüm Gülşen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GAÜN-SBF-PHD-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be publicly shared. The dataset includes sensitive clinical information from patients undergoing hemodialysis, and ethical approval and informed consent were obtained under the condition that data would be used only for scientific analysis within the research team. Due to privacy and confidentiality considerations, and in accordance with institutional data protection policies, individual-level data will not be made available for external sharing. Aggregated results are reported in the publication.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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