NCT07657923

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 18, 2026

Completed
Last Updated

June 25, 2026

Status Verified

June 1, 2026

Enrollment Period

10 months

First QC Date

June 15, 2026

Last Update Submit

June 23, 2026

Conditions

Keywords

Hemodialysisarteriovenous fistulaacupressuremusic therapyprocedural painnursing care

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity During AVF Cannulation (VAS Score)

    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 Outcomes (1)

  • Change in Pain Scores Over Time

    Baseline and across 3 consecutive hemodialysis sessions

Study Arms (4)

Music-Assisted Acupressure Group

OTHER

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

Acupressure

OTHER

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

Music Group

OTHER

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

Standard Care

OTHER

Routine hemodialysis care without additional music or acupressure intervention during AVF cannulation.

Other: Standard Care

Interventions

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.

Music Group

Manual acupressure applied to the Hegu (LI4) point on the hand contralateral to the AVF site for approximately 3 minutes prior to AVF cannulation.

Acupressure

Listening to instrumental Classical Turkish Music (Acemaşiran mode) via headphones starting 5 minutes before AVF cannulation and continuing throughout the procedure.

Music-Assisted Acupressure Group

Routine hemodialysis care without additional music or acupressure intervention during AVF cannulation.

Standard Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep Şehir Hastanesi

Gaziantep, Şahinbey, 27470, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Pain, ProceduralArteriovenous Fistula

Interventions

Music TherapyAcupressureStandard of Care

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsArteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular FistulaVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFistulaPathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and ActivitiesTherapy, Soft TissueMusculoskeletal ManipulationsPhysical Therapy ModalitiesQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No blinding was applied in this study. Due to the nature of the interventions (music therapy and acupressure), participants, care providers, and investigators were not blinded. Outcome assessment was performed by the same researcher who collected the data; therefore, no additional masked parties were included.
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: This study employed a 2×2 factorial randomized controlled design to evaluate the independent and combined effects of music therapy and acupressure on procedural pain during arteriovenous fistula (AVF) cannulation in hemodialysis patients. Participants were randomly assigned to one of four groups: music-assisted acupressure, acupressure only, music only, or routine care (control). This design allowed the assessment of main effects of each intervention as well as their potential interaction effect on pain intensity measured by the Visual Analog Scale (VAS).
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Specialist Nurse (PhD Candidate)

Study Record Dates

First Submitted

June 15, 2026

First Posted

June 18, 2026

Study Start

February 1, 2024

Primary Completion

November 30, 2024

Study Completion

November 30, 2024

Last Updated

June 25, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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.

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