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临床试验/NCT06478524
NCT06478524已完成不适用

Music Intervention for Dialysis Patients

National University of Singapore4 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2024年5月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
102
试验地点
4
主要终点
DASS-21

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Supportive Care
盲法
None

盲法说明

Masking cannot be performed as participants will know whether they are receiving live or recorded music.

入排标准

年龄范围
21 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Diagnosed dementia or cognitive impairment
  • Diagnosed psychiatric disorder

研究组 & 干预措施

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.

干预措施: Pre-recorded music (Behavioral)

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.

干预措施: Live music (Behavioral)

结局指标

主要结局

DASS-21

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

Mental Health

次要结局

  • WHO-5(Baseline measurements taken at the end of weeks 1 and 3, intervention measurements taken at the end of weeks 2 and 4.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kathleen Rose Agres

Assistant Professor

National University of Singapore

研究点 (4)

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