NCT07772583

Brief Summary

The aim of this study is to evaluate the effects of music therapy on pain intensity, anxiety levels, and hemodynamics (vital signs) in end-stage renal disease (ESRD) patients undergoing maintenance hemodialysis. This study employs a quasi-experimental design with a pretest-posttest control group, conducted among patients receiving routine hemodialysis treatment at the DaViVa Göztepe Dialysis Center. Participants in the intervention group receive music therapy applied in 30-minute sessions at the beginning of each hour throughout their hemodialysis treatments (specifically during vascular access/cannulation and dialytic sessions), while the control group receives standard nursing care. Objective physiological parameters along with validated subjective pain and anxiety scales are measured before and after the intervention to determine the therapeutic efficacy of music as a non-pharmacological nursing intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2025

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

June 23, 2025

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 19, 2026

Completed
Last Updated

August 19, 2026

Status Verified

August 1, 2026

Enrollment Period

14 days

First QC Date

August 8, 2026

Last Update Submit

August 18, 2026

Conditions

Keywords

HemodialysisMusic TherapyPainAnxietyStressVital SignsNursing

Outcome Measures

Primary Outcomes (1)

  • Level of Pain

    Scale Name: Visual Analog Scale (VAS) for Pain / Perceived Pain Severity Description: The Visual Analog Scale (VAS) is a validated, unidimensional, continuous measuring instrument used to assess subjective pain intensity. It consists of a horizontal straight line, typically 100 millimeters (or 10 centimeters) in length, anchored by two extreme verbal descriptors: "0" representing "No Pain" at the left endpoint and "10" (or "100 mm") representing "Worst Possible Pain / Unbearable Pain" at the right endpoint. Participants mark a point on the line corresponding to their currently perceived level of pain (specifically evaluated during arteriovenous fistula/graft cannulation and throughout the hemodialysis session). Pain intensity is measured in millimeters (0-100 mm) or centimeters (0-10 cm) from the left end to the patient's mark. Higher scores indicate greater pain severity.

    Baseline and immediately after the intervention

Study Arms (2)

Control Group

NO INTERVENTION

Participants in this group received no intervention and followed standard routıne procedures

Intervention Group

EXPERIMENTAL

Participants in this grup received the experimental interventionin addition to standard care.

Behavioral: Music intervention

Interventions

Music therapy intervention was applied to participants in the experimental group during treatment sessions.

Intervention Group

Eligibility Criteria

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

You may qualify if:

  • Aged 18 years and older,
  • Receiving hemodialysis (HD) treatment for at least 6 months,
  • Scheduled for HD treatment 3 days a week,
  • Free of hearing impairment,
  • Voluntarily agreeing to participate in the study. -

You may not qualify if:

  • Engaging in another complementary and integrative therapy,
  • Unwilling to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Daviva Goztepe Dialysis Center

Izmir, 35390, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Inclusion Criteria: Registered at the Daviva Göztepe Dialysis Center, Aged 18 years and older, Receiving hemodialysis (HD) treatment for at least 6 months, Scheduled for HD treatment 3 days a week, Free of hearing impairment, Voluntarily agreeing to participate in the study. Exclusion Criteria: Having a psychiatric diagnosis or hemodynamically unstable condition, Engaging in another complementary and integrative therapy, Unwilling to participate in the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 8, 2026

First Posted

August 19, 2026

Study Start

June 23, 2025

Primary Completion

July 7, 2025

Study Completion

July 12, 2025

Last Updated

August 19, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared to protect patient privacy and confidentiality.

Locations