An interventional study of Music intervention in Hemodialysis, Pain and Anxiety, sponsored by Izmir Tinaztepe University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Izmir Tinaztepe University · Not applicable, Interventional, and Supportive care
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.
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.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's enrollment of 68 is close to the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →Izmir Tinaztepe University is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
-
Participants in this group received no intervention and followed standard routıne procedures
Participants in this grup received the experimental interventionin addition to standard care.
Behavioral: Music intervention
Music therapy intervention was applied to participants in the experimental group during treatment sessions.
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.
Time frame: Baseline and immediately after the intervention
Plan to share: No — Individual participant data will not be shared to protect patient privacy and confidentiality.
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Izmir Tinaztepe University