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Renal FailureNCT06478524

Music Intervention for Dialysis Patients

A study testing Live music and Pre-recorded music in people with Renal Failure, run by National University of Singapore at 2 sites in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial is to examine the efficacy of both live and pre-recorded music interventions on alleviating the negative effects of dialysis treatment. The main questions it aims to answer are: Does music intervention have an effect on experienced pain, itch, anxiety, depression, and quality of life in… Read more about this study

Who is it for?
Ages 21 to 90 years
Conditions the study is for
Renal Failure
What is being tested?
Live music and Pre-recorded music
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
2 sitesSingapore
Study dates
27 May 2024to 22 Jun 2024
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 21 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Are between 21 and 90 years old
  • Undergoing dialysis at the Corporation Road level 1 or Clementi NKF dialysis centre
  • Normal or corrected hearing
  • Willing to stay awake and listen during the music intervention
  • Are able to speak English, Mandarin, Malay, or Hokkien

Who cannot join

  • Diagnosed dementia or cognitive impairment
  • Diagnosed psychiatric disorder

Trial locations and contacts

2 sites in 1 country.

Singapore2 sites
  • NKF Clementi Dialysis Centre

    Singapore, 120326

  • Integrated Renal Care Centre

    Singapore, 649808

Other trials in Singapore

About this study

The goal of this clinical trial is to examine the efficacy of both live and pre-recorded music interventions on alleviating the negative effects of dialysis treatment.

The main questions it aims to answer are:

Read more
  • Does music intervention have an effect on experienced pain, itch, anxiety, depression, and quality of life in dialysis patients?
  • To what extent do pre-recorded and live music performances differ in their effect on experienced pain, itch, anxiety, depression, and quality of life in dialysis patients?

Participants will Attend their regularly scheduled dialysis appointments for one week, and baseline data will be gathered (pain/itch NRS, WHO-5, DASS21).

During the second week, participants will be exposed to live music, and research data will be gathered.

This process will then be repeated in weeks 3 and 4, but with pre-recorded music as the intervention method.

Researchers will compare baseline data to intervention data (within group comparison), as well as live music to pre-recorded (between group comparison).

Read the detailed description

Singapore leads the world in the prevalence of diabetes-induced kidney failure, with approximately 6 new kidney failure patients diagnosed daily (US International Trade Administration, 2023). A growing body of research underscores the effectiveness of music interventions in mitigating the adverse impacts of dialysis. While the literature supports the efficacy of music interventions in alleviating the negative effects of dialysis, it is noteworthy that such interventions have not been conducted locally in Singapore. Our forthcoming study aims to address this gap by implementing a 2-armed investigation, comparing participants' baseline scores with live, pre-recorded music groups. We will assess mental health (including depression, anxiety, and stress), pain, itching, and quality of life scores in patients undergoing dialysis, with the overarching objective of ameliorating the negative effects associated with dialysis through music. Furthermore, distinctions in the effects of pre-recorded versus live music remain unexplored in this particular medical context. We hypothesize that scores from both music groups will improve compared to baseline control scores, and that the impact will be greater in the live intervention group compared to the pre-recorded music group.

Research procedures will take place at two National Kidney Foundation dialysis centres, at Corporation Road level 1 and at Clementi in Singapore. Procedures involve the TENG ensemble playing music, either live onsite or pre-recorded, for approximately 45 minutes to 1 hour at the centres while patients are midway through their dialysis treatment, around the end of the first hour or during the second hour. Each participant will experience a total of 3 music intervention sessions in either the live music or pre-recorded music group. Thus, each participant will experience a total of 6 research visits, 3 baseline sessions in the first week and 3 intervention sessions in the second week. Due to the nature of the study, neither participants nor research assistants can be blinded to the mode of intervention.

In total, the research team will make 20 research visits over 4 weeks, with 3 visits for each centre in the intervention weeks (Week 2 and Week 4), and 2 visits in the baseline weeks (Week 1 and Week 3). These visits will span about 3-4 hours per dialysis session. The second session of each week will not involve any data collection, for a total of 16 visits involving data collection, or 8 at each centre, over 4 weeks. One research assistant will still be present on the second session of the intervention weeks to ensure that the music is played appropriately. Participants will be reimbursed at the end of each week.

Variables of interest include quality of life, depression, anxiety, and stress scores will also be collected in addition to the pain and itch scores. The pain and itch survey is a simple 10 point numerical rating scale, and will take approximately 1 to 2 minutes to complete. The quality of life, depression, anxiety, and stress questionnaire will take approximately 12 minutes to complete. It includes the WHO 5 Wellbeing index, and the Depression and Anxiety Stress Scale 21 (DASS-21). The findings from these surveys will assist in illustrating the effects of music based interventions on the side effects of dialysis. This study also aims to demonstrate the value of music interventions as a low-risk, cost-effective form of Complementary and Alternative Medicine (CAM).

In summary, our study seeks to provide the first local evidence, to our knowledge, supporting the efficacy of music interventions for dialysis patients in Singapore. This will also be the first study internationally to rigorously examine the differences between live and pre-recorded music interventions for this clinical population.

Conditions
Renal Failure
Being tested
Live music, Pre-recorded music
Keywords
music, dialysis, mental health, quality of life, pain, itch
Medical subject headings
Renal Insufficiency, Psychological Well-Being, Pain, Pruritus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Live musicBehavioural

    Patients will have baseline data collection in the first week, followed by live music sessions and data collection during dialysis in the second week. The live music will be played for 45 minutes to one hour per dialysis session, and will be played during each of patients' three dialysis sessions in week 2 of this arm of the study.

  • Pre-recorded musicBehavioural

    Patients will have baseline data collection in the first week, followed by pre-recorded music sessions and data collection during dialysis in the second week. The pre-recorded music will be played for 45 minutes to one hour per dialysis session, and will be played during each of patients' three dialysis sessions in week 2 of this arm of the study.

Study groups in NCT06478524
Study groupRoleWhat they receive
Live musicExperimentalPatients will have baseline data collection in the first week, followed by live music sessions and data collection during dialysis in the second week.
Receives: Behavioral: Live music
Pre-recorded musicActive comparatorPatients will have baseline data collection in the first week, followed by pre-recorded music sessions and data collection during dialysis in the second week.
Receives: Behavioral: Pre-recorded music

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DASS-21

    Mental Health

    Measured: Baseline measurements taken at the end of weeks 1 and 3, intervention measurements taken at the end of weeks 2 and 4.

Secondary outcomes (1)
  1. WHO-5

    Quality of Life

    Measured: Baseline measurements taken at the end of weeks 1 and 3, intervention measurements taken at the end of weeks 2 and 4.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2024
  2. Study start27 May 2024
  3. Primary completion22 Jun 2024
  4. Study completion22 Jun 2024

Resources

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
Non-randomised
Intervention model
Sequential
Model description
Non-Parallel, Sequentially Allocated study design: This study involves two arms, with one arm receiving a live music intervention, and the other arm receiving a pre-recorded music intervention. The interventions are administered sequentially, with the live music intervention being conducted first across four patient groups, followed by the pre-recorded music intervention for a separate set of four patient groups.
Masking
None (open label)
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06478524
Sponsor's protocol ID
NUS-IRB-2023-620
Status last verified
Jun 2025
First submitted
22 Jun 2024
Last updated
16 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Coded participant data will only be available within the research team. IPD will not be shared outside of the research team.

Publications

  • Aalbers S, Fusar-Poli L, Freeman RE, Spreen M, Ket JC, Vink AC, Maratos A, Crawford M, Chen XJ, Gold C. Music therapy for depression. Cochrane Database Syst Rev. 2017 Nov 16;11(11):CD004517. doi: 10.1002/14651858.CD004517.pub3.

    PubMed 29144545
  • Burrai F, Micheluzzi V, Zito MP, Pietro G, Sisti D. Effects of live saxophone music on physiological parameters, pain, mood and itching levels in patients undergoing haemodialysis. J Ren Care. 2014 Dec;40(4):249-56. doi: 10.1111/jorc.12078. Epub 2014 Jul 1.

    PubMed 24980265
  • Burrai F, Lupi R, Luppi M, Micheluzzi V, Donati G, Lamanna G, Raghavan R. Effects of Listening to Live Singing in Patients Undergoing Hemodialysis: A Randomized Controlled Crossover Study. Biol Res Nurs. 2019 Jan;21(1):30-38. doi: 10.1177/1099800418802638. Epub 2018 Sep 24.

    PubMed 30249121
  • Cheng J, Zhang H, Bao H, Hong H. Music-based interventions for pain relief in patients undergoing hemodialysis: A PRISMA-compliant systematic review and meta-analysis. Medicine (Baltimore). 2021 Jan 15;100(2):e24102. doi: 10.1097/MD.0000000000024102.

    PubMed 33466179
  • Chung CW, Kalbavi V, Siegel JB, Taber DJ, Rohan V. Music Therapy in Dialysis Access Procedures With Moderate Sedation. Am Surg. 2022 Jan;88(1):70-73. doi: 10.1177/0003134820973383. Epub 2020 Dec 28.

    PubMed 33371722
  • Inayama E, Yamada Y, Kishida M, Kitamura M, Nishino T, Ota K, Takahashi K, Shintani A, Ikenoue T. Effect of Music in Reducing Pain during Hemodialysis Access Cannulation: A Crossover Randomized Controlled Trial. Clin J Am Soc Nephrol. 2022 Sep;17(9):1337-1345. doi: 10.2215/CJN.00360122. Epub 2022 Aug 24.

    PubMed 36002178
  • Kim S, Jeong H. Effects of Patient-Selected Music Listening on the Pain and Anxiety of Patients Undergoing Hemodialysis: A Randomized Controlled Trial. Healthcare (Basel). 2021 Oct 25;9(11):1437. doi: 10.3390/healthcare9111437.

    PubMed 34828484
  • Lin YJ, Lu KC, Chen CM, Chang CC. The effects of music as therapy on the overall well-being of elderly patients on maintenance hemodialysis. Biol Res Nurs. 2012 Jul;14(3):277-85. doi: 10.1177/1099800411413259. Epub 2011 Jun 27.

    PubMed 21708894
  • Martin-Saavedra JS, Vergara-Mendez LD, Talero-Gutierrez C. Music is an effective intervention for the management of pain: An umbrella review. Complement Ther Clin Pract. 2018 Aug;32:103-114. doi: 10.1016/j.ctcp.2018.06.003. Epub 2018 Jun 7.

    PubMed 30057035
  • Pothoulaki M, Macdonald RA, Flowers P, Stamataki E, Filiopoulos V, Stamatiadis D, Stathakis ChP. An investigation of the effects of music on anxiety and pain perception in patients undergoing haemodialysis treatment. J Health Psychol. 2008 Oct;13(7):912-20. doi: 10.1177/1359105308095065.

    PubMed 18809642
  • Soliva MS, Salvador IR, Testal AG, Lopez CC, Ramon RO, Coca JV, Maset RG. Intervention study to verify the effect of live classic music during hemodialysis on the quality of life of patients with chronic kidney disease. Nefrologia (Engl Ed). 2022 Sep-Oct;42(5):559-567. doi: 10.1016/j.nefroe.2021.07.010. Epub 2023 Feb 2.

    PubMed 36739245

Questions about this trial

What is this clinical trial studying?

A study testing Live music and Pre-recorded music in people with Renal Failure, run by National University of Singapore at 2 sites in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. 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 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Singapore. 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?

DASS-21 (time frame: Baseline measurements taken at the end of weeks 1 and 3, intervention measurements taken at the end of weeks 2 and 4.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06478524, which also lists 11 linked publications.

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 16 Jun 2026.

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