Music Interventions for Patients Undergoing Hemodialysis

A Randomized Controlled Pilot Study Evaluating the Effect of Patient-tailored Live Music Interventions for Patients Undergoing Hemodialysis

Fatigue is found to be one of the most persistent problems among patients in treatment with hemodialysis, and associated with impaired health-related quality of life. A few, non-randomized controlled trials have found positive effects on fatigue by offering pre-recorded music intra-dialytic, however, without conclusive results. So far, no studies have investigated the feasibility of integrating person-tailored live music interventions performed by professional musicians into a hemodialysis setting. This leaves a deficit in knowledge for intervention planning, understanding and effectiveness of live music on fatigue, wellbeing and feelings of meaningfulness in this group of patients.

Methods: A pilot randomized controlled trial combined with qualitative methods. The data collection will involve recruitment of 24 patients from an outpatient clinic over a six-week period. The patients will be randomized into either an intervention group or a control group. Patients in the intervention group will be offered a 30-minute session of patient-tailored live music intervention per week for six consecutive weeks. Patients in the control group will receive standard care.

Quantitative analysis on immediate post-dialysis fatigue (VAS), and long-term fatigue (MFI-20), anxiety, depression (HADS) and treatment satisfaction (VAS) will show the potential effectiveness of intervention. Qualitative analysis of informal-interviews (patients/staff), observational data (patients) and focus group interviews (staff/musicians) will explore an in-depth understanding of whether music will improve wellbeing and create feelings of meaningfulness among this group of patients as well as to assess feasibility acceptability among patients, musicians and staff.

Perspectives: This trial will ensure a firm methodological approach for the development of a future definitive randomized controlled trial of music intervention for fatigue reduction and wellbeing among hemodialysis patients.

Study Overview

• Status: Completed
• Conditions: Renal Failure
• Intervention / Treatment: Other: Music Intervention

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Margrethe Langer Bro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18+
• Scheduled to receive hemodialysis treatment
• Able to understand written and spoken Danish

Exclusion Criteria:

• Deafness
• Severe mental illness

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Patients in the intervention group will receive 30 minutes of patient-tailored instrumental music in the beginning of one weekly hemodialysis treatment for a period of six weeks	Other: Music Intervention; After rating levels of fatigue and relaxation, the professional health care musicians will play 30 minutes of patient-tailored, pleasant instrumental music with a combination of relaxing (on average 60-80 bpm) and lively, slightly more up-beat tempo to regulate arousal-levels
No Intervention: Control group; The procedure in the control group is the same as in the intervention group, except that they don't listen to music

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immediate fatigue	Visual Analogue Scale (VAS). Higher VAS score means higher levels of fatigue	Change from baseline immediate fatigue at 8 weeks. VAS is measured at baseline (visit 1), after visit 2, visit 3, visit 4, visit 5, visit 6, visit 7 and at follow-up (visit 8).
Longterm fatigue	Multidimensional Fatigue Inventory (MFI-20). Higher MFI-20 score means higher levels of fatigue	Change from baseline longterm fatigue at 8 weeks. MFI-20 is measured at baseline (visit 1) and at follow-up (visit 8)
Post-dialysis fatigue-diary	Visual Analogue Scale (VAS). Higher VAS score means higher levels of fatigue	Change from baseline post dialysis fatigue at 8 weeks. Post-dialysis fatigue is measured the day after visit 2, visit, 3, visit 4, visit 5, visit, 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relaxation	Visual Analogue Scale. Higher VAS score means higher levels of relaxation	Change from baseline relaxation at 8 weeks. VAS is measured at baseline (visit 1), after visit 2, visit 3, visit 4, visit 5, visit 6, visit 7 and at followup (visit 8)
Anxiety and Depression	Hospital Anxiety Depression Scale (HADS). Higher HADS score means higher levels of anxiety and depression	Change from baseline anxiety and depression at 8 weeks. HADS is measured at baseline (visit 1) and follow-up (visit 8)
Treatment satisfaction	Visual Analogue Scale (VAS). Higher VAS score means higher levels of treatment satisfaction	Change from baseline treatment satisfaction at 8 weeks. VAS is measured at baseline (visit 1) and at follow-up (visit 8)
Work engagement (staff)	Utrecht Work Engagement Scale (UWES). Higher UWES score means higher levels of work engagement	Change from baseline work engagement at 8 weeks. UWES is measured at baseline (visit 1) and at follow-up (visit 8)

Collaborators and Investigators

• Sponsor: University of Southern Denmark
• Collaborators: Aarhus University Hospital; University of Aarhus; The Royal Academy of Music Aarhus/Aalborg; Hanze University; University of Music and Performing Arts, Vienna; University Hospital of Southern Denmark
• Investigators: Study Chair: Pia Dreyer, PhD, Institute of Public Health, University of Aarhus; Study Chair: Bibi Gram, PhD, Regional Health Research, University of Southern Denmark

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2021
• Primary Completion (Actual): August 19, 2021
• Study Completion (Actual): August 19, 2021

Study Registration Dates

• First Submitted: May 26, 2021
• First Submitted That Met QC Criteria: July 1, 2021
• First Posted (Actual): July 13, 2021

Study Record Updates

• Last Update Posted (Actual): October 8, 2021
• Last Update Submitted That Met QC Criteria: October 1, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Feasibility; Kidney failure; Renal dialysis; Music intervention; Mixed method; Randomized Controlled Pilot Study
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency
• Other Study ID Numbers: Music & Hemodialysis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No