Clinical trial NCT06478524: Music Intervention for Dialysis Patients
Official title: Music Intervention for Dialysis Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Renal Failure
Keywords: music
dialysis
mental health
quality of life
pain
itch
Lead sponsor: National University of Singapore
Sponsor class: OTHER
Collaborators: name: National Kidney Foundation, United States
First posted: 2024-06-27
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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).

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Diagnosed dementia or cognitive impairment
* Diagnosed psychiatric disorder

Primary outcomes:
measure: DASS-21
timeFrame: Baseline measurements taken at the end of weeks 1 and 3, intervention measurements taken at the end of weeks 2 and 4.
Secondary outcomes:
measure: WHO-5
timeFrame: Baseline measurements taken at the end of weeks 1 and 3, intervention measurements taken at the end of weeks 2 and 4.
Other outcomes:
measure: Pain and itch numerical ranking scale
timeFrame: Twice per week (first and third session of the week), for both baseline and intervention. Taken across all 4 weeks.
Locations:
city: Singapore
country: Singapore
facility: NKF Clementi Dialysis Centre
city: Singapore
country: Singapore
facility: Integrated Renal Care Centre
Study officials:
References:
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