Ignite Creation Date:
2024-07-17 @ 11:18 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06478524
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-22
Brief Title:
Music Intervention for Dialysis Patients
Sponsor:
National University of Singapore
Organization:
National University of Singapore
Study Overview
Official Title:
Music Intervention for Dialysis Patients
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 painitch 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
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 painitch 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None