Music Intervention for Dialysis Patients

NCT06478524 | Recruiting

• 1 other identifier: NUS-IRB-2023-620
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief 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 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).

Conditions

Renal Failure

Keywords

music; dialysis; mental health; quality of life; pain; itch

Outcome Measures

Primary Outcomes (1)

• DASS-21

  Mental Health

  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)

• WHO-5

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

Other Outcomes (1)

• Pain and itch numerical ranking scale

  Twice per week (first and third session of the week), for both baseline and intervention. Taken across all 4 weeks.

Study Arms (2)

Live music

EXPERIMENTAL

Patients will have baseline data collection in the first week, followed by live music sessions and data collection during dialysis in the second week.

Behavioral: Live music

Pre-recorded music

ACTIVE COMPARATOR

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.

Behavioral: Pre-recorded music

Interventions

Live music BEHAVIORAL

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.

Live music

Pre-recorded music BEHAVIORAL

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.

Pre-recorded music

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Diagnosed dementia or cognitive impairment
• Diagnosed psychiatric disorder

Sponsors & Collaborators

• National University of Singapore: lead
• National Kidney Foundation, United States: collaborator

Study Sites (2)

NKF Clementi Dialysis Centre

Singapore, 120326, Singapore

RECRUITING

Integrated Renal Care Centre

Singapore, 649808, Singapore

RECRUITING

Related Publications (11)

• 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.

  PMID: 29144545 BACKGROUND

• 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.

  PMID: 24980265 BACKGROUND

• 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.

  PMID: 30249121 BACKGROUND

• 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.

  PMID: 33466179 BACKGROUND

• 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.

  PMID: 33371722 BACKGROUND

• 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.

  PMID: 36002178 BACKGROUND

• 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.

  PMID: 34828484 BACKGROUND

• 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.

  PMID: 21708894 BACKGROUND

• 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.

  PMID: 30057035 BACKGROUND

• 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.

  PMID: 18809642 BACKGROUND

• 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.

  PMID: 36739245 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency; Psychological Well-Being; Pain; Pruritus

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Personal Satisfaction; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations

Central Study Contacts

Kathleen R Agres, PhD

CONTACT

98996363; katagres@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Masking cannot be performed as participants will know whether they are receiving live or recorded music.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 22, 2024
• First Posted: June 27, 2024
• Study Start: May 27, 2024
• Primary Completion: June 22, 2024
• Study Completion: December 31, 2025
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)