Clinical trial NCT04959682: Music Interventions for Patients Undergoing Hemodialysis
Official title: A Randomized Controlled Pilot Study Evaluating the Effect of Patient-tailored Live Music Interventions for Patients Undergoing Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Failure
Keywords: Music intervention
Feasibility
Kidney failure
Mixed method
Renal dialysis
Randomized Controlled Pilot Study
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: The Royal Academy of Music Aarhus/Aalborg
name: Aarhus University Hospital
name: University of Aarhus
name: Hanze University of Applied Sciences Groningen
name: University of Music and Performing Arts, Vienna
name: University Hospital of Southern Denmark
First posted: 2021-07-13
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Deafness
* Severe mental illness

Primary outcomes:
measure: Immediate fatigue
timeFrame: 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).
measure: Longterm fatigue
timeFrame: Change from baseline longterm fatigue at 8 weeks. MFI-20 is measured at baseline (visit 1) and at follow-up (visit 8)
measure: Post-dialysis fatigue-diary
timeFrame: 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 outcomes:
measure: Relaxation
timeFrame: 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)
measure: Anxiety and Depression
timeFrame: Change from baseline anxiety and depression at 8 weeks. HADS is measured at baseline (visit 1) and follow-up (visit 8)
measure: Treatment satisfaction
timeFrame: Change from baseline treatment satisfaction at 8 weeks. VAS is measured at baseline (visit 1) and at follow-up (visit 8)
measure: Work engagement (staff)
timeFrame: Change from baseline work engagement at 8 weeks. UWES is measured at baseline (visit 1) and at follow-up (visit 8)
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Margrethe Langer Bro
Study officials:
affiliation: Institute of Public Health, University of Aarhus
name: Pia Dreyer, PhD
role: STUDY_CHAIR
affiliation: Regional Health Research, University of Southern Denmark
name: Bibi Gram, PhD
role: STUDY_CHAIR
References: