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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.
Age
All ages
Sex
ALL
Healthy Volunteers
No
Margrethe Langer Bro
Odense, Denmark
Start Date
April 21, 2021
Primary Completion Date
August 19, 2021
Completion Date
August 19, 2021
Last Updated
October 8, 2021
24
ACTUAL participants
Music Intervention
OTHER
Lead Sponsor
University of Southern Denmark
Collaborators
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07237633