HemodialysisNCT07772583
THE EFFECT OF MUSİC THERAPY IN HEMODİALYSİS PATİENTS
A study testing Music intervention in people with Hemodialysis and Pain, run by Izmir Tinaztepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemodialysis, Pain, Anxiety
- What is being tested?
- Music intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jun 2025to 12 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EFFECTİVENESS OF MUSİC THERAPY ON PAİN, ANXİETY AND LİFE PARAMETERS OF 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.
Read the detailed description
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.
- Conditions
- Hemodialysis, Pain, Anxiety, Stress
- Being tested
- Music intervention
- Keywords
- Hemodialysis, Music Therapy, Pain, Anxiety, Stress, Vital Signs, Nursing
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music interventionBehavioural
Music therapy intervention was applied to participants in the experimental group during treatment sessions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Music intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start23 Jun 2025
- Primary completion7 Jul 2025
- Study completion12 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Tinaztepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Tüfekcioglu, Izmir Tinaztepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772583
- Sponsor's protocol ID
- MUKCE2025/45
- Status last verified
- Aug 2026
- First submitted
- 8 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect patient privacy and confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTİVENESS OF MUSİC THERAPY ON PAİN, ANXİETY AND LİFE PARAMETERS OF HEMODİALYSİS PATİENTS
- ClinicalTrials.gov ID
- NCT07772583
- Acronym / sponsor ID
- MUKCE2025/45
- Conditions
- Hemodialysis, Pain, Anxiety, Stress
- Keywords
- Hemodialysis, Music Therapy, Pain, Anxiety, Stress, Vital Signs, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Izmir Tinaztepe UniversityUniversity, hospital or other
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- 7 Jul 2025 (actual)
- Study completion
- 12 Jul 2025 (actual)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Participants in this group received no intervention and followed standard routıne procedures |
| Intervention Group | Experimental | Behavioral: Music interventionParticipants in this grup received the experimental interventionin addition to standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music interventionMusic therapy intervention was applied to participants in the experimental group during treatment sessions. | Behavioural | Intervention Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect patient privacy and confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music intervention in people with Hemodialysis and Pain, run by Izmir Tinaztepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Pain (time frame: Baseline and immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.