NCT07320859

Brief Summary

Inserting needles into the vascular access (fistula) is a major source of pain and anxiety for many hemodialysis patients. This study compared two simple, non-drug techniques to reduce this pain: listening to music and looking into a mirror during the needle insertion. A total of 75 adult patients receiving regular hemodialysis at Izmir Özel Can Dialysis Center were randomly divided into three groups: a music group, a mirror group, and a control group. Patients in the music group listened to calming, instrumental Turkish classical music (makam) via headphones during cannulation. Patients in the mirror group looked at the reflection of their healthy arm in a mirror. The control group received standard care without these interventions. Pain intensity was measured immediately after needle insertion using a 10-cm Visual Analogue Scale (VAS), where 0 means "no pain" and 10 means "the worst imaginable pain." Pain scores were compared between the groups to determine which method was more effective. The results of this study may provide nurses and patients with easy-to-use, evidence-based options to make hemodialysis needle procedures less painful and stressful.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2025

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2025

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 6, 2026

Completed
Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

Same day

First QC Date

December 15, 2025

Last Update Submit

January 6, 2026

Conditions

Keywords

Mirror TherapyMusic TherapyNon-pharmacological Pain ManagementHemodialysisVascular AccessCannulation Pain

Outcome Measures

Primary Outcomes (1)

  • Procedural pain intensity during arteriovenous fistula cannulation

    Pain intensity experienced by the patient immediately following the needle insertion for hemodialysis. This primary outcome is measured during the second and third hemodialysis sessions following randomization (the first session post-randomization served as a runin with no intervention). Pain is measured using a 10-cm Visual Analogue Scale (VAS). Scores range from 0 to 10, where 0 cm represents 'no pain' and 10 cm represents 'the worst pain imaginable,' and higher scores indicate worse pain (greater pain intensity). The patient marks their pain level on the line, and the score is recorded in centimeters.

    Procedure (during cannulation)

Study Arms (3)

Mirror group

EXPERIMENTAL

During arteriovenous fistula cannulation, patients viewed the reflection of their healthy arm in a 40-cm mirror placed approximately 30 cm away. They focused on this image for 10 minutes before cannulation (adaptation phase), and the procedure was performed while they continued to look at the mirror. The visual illusion aimed to modulate pain perception.

Device: Mirror Therapy (Visual Illusion Therapy)

Music group

EXPERIMENTAL

During arteriovenous fistula cannulation, patients listened to pre-selected, calming instrumental Turkish classical music (Nihavend and Muhayyerkürdi maqams) via headphones and an MP3 player at a comfortable volume. The music started before cannulation and continued throughout the procedure.

Other: Music Therapy

Control group

NO INTERVENTION

Patients received routine, standard cannulation care as per the hemodialysis unit protocol, without any additional non-pharmacological intervention such as mirror or music therapy.

Interventions

A non-pharmacological, complementary therapy. Patients listen to pre-recorded, instrumental Turkish classical music (specifically Nihavend and Muhayyerkürdi maqams) via headphones during the cannulation procedure. The music is selected for its calming properties and starts before needle insertion. The intervention aims to reduce pain and anxiety through auditory distraction, emotional modulation, and relaxation.

Music group

A non-pharmacological, behavioral intervention. A standard mirror (40 cm diameter) is positioned to allow the patient to view the reflection of their non-cannulated, healthy arm during arteriovenous fistula cannulation. The patient focuses on this visual illusion for an adaptation period (10 minutes) before the needle insertion. The intervention is based on the principles of graded motor imagery and aims to reduce procedural pain by modulating cortical representation and attention.

Mirror group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being 18-85 years of age or older
  • Receiving HD treatment 3 days a week
  • Being able to read and write
  • Having no hearing impairment
  • Having Turkish as their native language
  • Having received HD treatment for at least 6 months
  • Having a VAS pain score \>3
  • Agreeing to listen to music

You may not qualify if:

  • Having a psychological disorder
  • Having communication problems
  • Having cancer
  • Not wanting to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Kavram Vocational School

Konak, İzmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicPain, ProceduralArteriovenous Fistula

Interventions

Mirror Movement TherapyMusic Therapy

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsArteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular FistulaVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFistulaPathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesRehabilitationTherapeuticsSensory Art TherapiesComplementary TherapiesAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Due to the nature of the interventions (music listening and mirror viewing), participants and the nurses providing care were not blinded to group assignment. However, the statistician who performed the final data analysis was blinded to group allocation.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned in a 1:1:1 ratio to one of three parallel groups for the duration of the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Dr

Study Record Dates

First Submitted

December 15, 2025

First Posted

January 6, 2026

Study Start

December 1, 2025

Primary Completion

December 1, 2025

Study Completion

December 6, 2025

Last Updated

January 8, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

The datasets generated during this study are not publicly available due to the small sample size and the potential risk of compromising individual privacy, even after de-identification. However, anonymized data may be made available from the corresponding author upon reasonable request and with permission from the institutional ethics committee.

Locations