Completed

NCT Number: NCT07772583

THE EFFECT OF MUSİC THERAPY IN HEMODİALYSİS PATİENTS

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.

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Key information

Conditions

Hemodialysis Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stress

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Daviva Goztepe Dialysis Center

Izmir, 35390, Turkey (Türkiye)

About this study

This study is designed as a quasi-experimental, pretest-posttest control group trial to systematically evaluate the psychophysiological effects of music therapy among end-stage renal disease (ESRD) patients undergoing routine hemodialysis treatment at the DaViVa Göztepe Dialysis Center.

Background and Rationale:Hemodialysis patients frequently experience high levels of physical pain, anxiety, distress, and hemodynamic instability secondary to repeated arteriovenous fistula (AVF) / graft cannulations and long, machine-dependent dialytic procedures. Non-pharmacological supportive nursing interventions, such as music therapy, offer safe, non-invasive, and cost-effective adjunctive care to alleviate symptom burden and enhance patient comfort.

Intervention Protocol:Participants eligible for the study are allocated into an intervention group and a control group.

Intervention Group: Participants receive personalized, relaxing music via headphones during their hemodialysis sessions. The music therapy protocol is administered for 30 minutes at the top of every hour (30 minutes on, 30 minutes off per hour) throughout the entire duration of the treatment session, starting from the initial vascular access/cannulation phase.

Control Group: Participants receive standard routine nursing and clinical hemodialysis care without any musical intervention or auditory stimulation.

Outcome Evaluation:Subjective and objective clinical assessments are performed at baseline (pre-test) prior to cannulation and hemodialysis initiation, and immediately following the completed intervention sessions (post-test):Subjective Parameters: Perceived pain severity is evaluated using validated pain rating scales, and anxiety levels are assessed using standardized anxiety measurement instruments.Objective/Physiological Parameters: Hemodynamic and vital signs-including systolic and diastolic blood pressure, heart/pulse rate, respiratory rate, and oxygen saturation (SpO2)are continuously monitored and recorded at designated time intervals throughout the session.The primary objective is to test whether structured music therapy significantly reduces perceived cannulation and intradialytic pain intensity, lowers anxiety levels, and stabilizes hemodynamic vital parameters compared to standard care in hemodialysis patients.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Music intervention

Behavioral

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

Primary outcomes

Level of Pain

Time frame: Baseline and immediately after the intervention

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.

Sponsors and collaborators

Lead sponsor

Izmir Tinaztepe University

Other

Registry information

Official study title

EFFECTİVENESS OF MUSİC THERAPY ON PAİN, ANXİETY AND LİFE PARAMETERS OF HEMODİALYSİS PATİENTS

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Aug 19, 2026
Registry last updated: Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed