Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2024-05-27
2025-12-31
Brief Summary
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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 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).
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
SUPPORTIVE_CARE
NONE
Study Groups
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Live music
Patients will have baseline data collection in the first week, followed by live music sessions and data collection during dialysis in the second week.
Live music
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 music
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.
Pre-recorded music
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.
Interventions
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Live music
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 music
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Diagnosed psychiatric disorder
21 Years
90 Years
ALL
No
Sponsors
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National Kidney Foundation, United States
OTHER
National University of Singapore
OTHER
Responsible Party
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Kathleen Rose Agres
Assistant Professor
Locations
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NKF Clementi Dialysis Centre
Singapore, , Singapore
Integrated Renal Care Centre
Singapore, , Singapore
Countries
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Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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NUS-IRB-2023-620
Identifier Type: -
Identifier Source: org_study_id
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