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NCT04959682

Music Interventions for Patients Undergoing Hemodialysis

Completed NA Last updated 8 October 2021
What this trial tests

NA trial testing Music Intervention in Renal Failure in 24 participants. Completed in 19 August 2021.

Timeline
21 April 2021
Primary endpoint
19 August 2021
19 August 2021

Quick facts

Lead sponsorUniversity of Southern Denmark
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposesupportive care
Enrollment24
Start date21 April 2021
Primary completion19 August 2021
Estimated completion19 August 2021
Sites1 location across Denmark

Drugs / interventions tested

Conditions studied

Sponsor

University of Southern Denmark

Who can join

Eligibility, any sex, with Renal Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Music Intervention

Trials testing the same drug.

Other recruiting trials for Renal Failure

Currently open trials in the same condition.

Other University of Southern Denmark trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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