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Completed

NCT Number: NCT04959682

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Margrethe Langer Bro

Odense, 5000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Deafness
  • Severe mental illness

Treatment and study plan

Music intervention

Other

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

Primary outcomes

  1. Immediate fatigue

    Time frame: 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).

    Visual Analogue Scale (VAS). Higher VAS score means higher levels of fatigue

  2. Longterm fatigue

    Time frame: Change from baseline longterm fatigue at 8 weeks. MFI-20 is measured at baseline (visit 1) and at follow-up (visit 8)

    Multidimensional Fatigue Inventory (MFI-20). Higher MFI-20 score means higher levels of fatigue

  3. Post-dialysis fatigue-diary

    Time frame: 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

    Visual Analogue Scale (VAS). Higher VAS score means higher levels of fatigue

Secondary outcomes

  1. Relaxation

    Time frame: 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)

    Visual Analogue Scale. Higher VAS score means higher levels of relaxation

  2. Anxiety and Depression

    Time frame: Change from baseline anxiety and depression at 8 weeks. HADS is measured at baseline (visit 1) and follow-up (visit 8)

    Hospital Anxiety Depression Scale (HADS). Higher HADS score means higher levels of anxiety and depression

  3. Treatment satisfaction

    Time frame: Change from baseline treatment satisfaction at 8 weeks. VAS is measured at baseline (visit 1) and at follow-up (visit 8)

    Visual Analogue Scale (VAS). Higher VAS score means higher levels of treatment satisfaction

  4. Work engagement (staff)

    Time frame: Change from baseline work engagement at 8 weeks. UWES is measured at baseline (visit 1) and at follow-up (visit 8)

    Utrecht Work Engagement Scale (UWES). Higher UWES score means higher levels of work engagement

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Aarhus University Hospital
  • Esbjerg Hospital - University Hospital of Southern Denmark
  • Hanze University of Applied Sciences Groningen
  • The Royal Academy of Music Aarhus/Aalborg
  • University of Aarhus
  • University of Music and Performing Arts, Vienna

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 13, 2021
Registry last updated
Oct 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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