Music Interventions for Patients Undergoing Hemodialysis

Renal Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04959682
• Other study ID #: Music & Hemodialysis
• Status: Completed
• Phase: N/A
• Start date: April 21, 2021
• Est. completion date: August 19, 2021

Study information

• Verified date: October 2021
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 19, 2021
• Est. primary completion date: August 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Age 18+

• Scheduled to receive hemodialysis treatment

• Able to understand written and spoken Danish

Exclusion Criteria:

• Deafness

• Severe mental illness

Related Conditions & MeSH terms

• Renal Failure
• Renal Insufficiency

Intervention

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

Locations

Country	Name	City	State
Denmark	Margrethe Langer Bro	Odense

Sponsors (7)

Lead Sponsor	Collaborator
University of Southern Denmark	Aarhus University Hospital, Hanze University, The Royal Academy of Music Aarhus/Aalborg, University Hospital of Southern Denmark, University of Aarhus, University of Music and Performing Arts, Vienna

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)