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NCT04959682
Music Interventions for Patients Undergoing Hemodialysis
NA trial testing Music Intervention in Renal Failure in 24 participants. Completed in 19 August 2021.
19 August 2021
Quick facts
| Lead sponsor | University of Southern Denmark |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 24 |
| Start date | 21 April 2021 |
| Primary completion | 19 August 2021 |
| Estimated completion | 19 August 2021 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Music Intervention — full drug profile →
Conditions studied
- Renal Failure — all drugs for Renal Failure →
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:
- PubMed search for NCT04959682
- Europe PMC full search
- ASCO Meeting Library
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Related trials
Other trials of Music Intervention
Trials testing the same drug.
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- NCT05285995 — The Effect of Two Distraction Strategies in Reducing Preoperative Anxiety in Children · NA · completed
- NCT03676491 — Music to Improve Sleep Quality in Adults With Depression and Insomnia · NA · completed
Other recruiting trials for Renal Failure
Currently open trials in the same condition.
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- NCT06620523 — Prevent Cardiac Surgery Associated AKI Trial · Phase 2 · recruiting
Other University of Southern Denmark trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04959682 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Southern Denmark
- Last refreshed: 8 October 2021
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